SUN-LB115 Is the Stepping-Down Approach a Better Option Than Multiple Daily Injections in Patients With Chronic Poorly-Controlled Diabetes on Advanced Insulin Therapy?

Abstract In the traditional step-up approach, patients with poorly-controlled T2DM are eventually advanced to multiple daily insulin injections (MDI). However, some on advanced insulin therapy (AIT) continue to have poor control due to poor compliance with MDI and fear of insulin-induced weight gain. The recent guidelines recommend the use of anti-hyperglycemic agents with weight loss benefits, such as SGLT2i or GLP1 RA, with basal insulin before the patients are advanced to MDI. Objective: To determine if de-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin by using the stepping-down approach is a better option than MDI in obese patients with poorly- controlled T2DM on AIT. Research Design: This pilot, prospective, randomized, open-label, controlled, parallel-group trial enrolled 22 obese patients with T2DM on AIT, who had BMI ≥30 kg/m2, A1c >8% and eGFR >45. Patients were randomized to either intervention (Step-Down) or control (MDI) group. In the control group, the patient was advised to remain on MDI. In the intervention group, all prandial insulin injections were discontinued; but the patient remained on the basal insulin and metformin to which SGLT2i, Empagliflozin, and GLP1 RA, Dulaglutide, were added. They were followed up for 16 weeks. The primary outcome was A1c change and secondary outcomes were the change in fasting BG, weight, BP, HR, fasting lipids, serum Na and K, serum Cr, liver enzymes, CBC and Diabetes Medications Satisfaction (DM-SAT) scores at 16 weeks. Results: There was no difference in A1c between 2 groups (10.36% vs 9.69%;p=0.171) at baseline. However, A1c was significantly lower at 4 weeks (9.54% vs 7.31%; p=0.0088) and 16 weeks (9.7% vs 8.25%; p<0.001) in intervention group (n=10). Compared to baseline, in the control group (n=8), there was no significant change at secondary outcome variables except slightly higher SBP at 16 weeks. In intervention group, compared to baseline, there was a significant decrease in weight (-16.38 Lbs; p=0.003), BMI (-3.06; p<0.001), LDL cholesterol (-15.7 mg/d; p=0.0378), total cholesterol (-18.5 mg/dL; p=0.0386), total daily insulin dose (-57.3 units; p<0.001) and a significant improvement in DM-SAT patient satisfaction 0-100 scores - total score (+45.3; p <0.001) and subscale scores (Convenience +35.28, p =0.019; Lifestyle +35.8, p=0.0052; Medical control +51.3, p<0.001; Wellbeing +47.2,p=0.0091) at 16 weeks. Conclusions: De-escalating from AIT to the combined use of metformin, SGLT2i, GLP1 RA and basal insulin in obese patients with poorly-controlled T2DM by using the stepping-down approach results in the significant improvement in glycemic control, weight loss, and significantly higher patient satisfaction. This noble stepping-down approach may be a better option than continuing MDI in such patients. This pilot study result needs to be confirmed with a larger trial. ClinicalTrials ID: NCT02846233

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Randomized Trial for Weight Loss Using a Digital Therapeutic Application

Journal of Diabetes Science and Technology ◽

10.1177/19322968211000815 ◽

2021 ◽

pp. 193229682110008

Author(s):

Tryggvi Thorgeirsson ◽

Johanna E. Torfadottir ◽

Erlendur Egilsson ◽

Saemundur Oddsson ◽

Thrudur Gunnarsdottir ◽

...

Keyword(s):

Weight Loss ◽

Mobile Application ◽

Intervention Group ◽

Lifestyle Change ◽

Noncommunicable Diseases ◽

Control Group ◽

Intention To Treat ◽

Protocol Group ◽

Lifestyle Program ◽

Program Intervention

Background: Smartphones present a near-ubiquitous channel through which structured lifestyle change can reduce risk or progression of the most common noncommunicable diseases. We explored whether a digital structured lifestyle program enhances weight loss. Methods: We randomized overweight and obese participants attending a four-month lifestyle change program to either standard weekly coaching sessions (controls), or standard treatment supplemented with a digital therapeutic mobile application (intervention). Changes in body mass index after four months were the main outcome measure. Odds ratios of achieving 5% weight loss were estimated with unconditional logistic regression. Results: Of 234 eligible persons, 146 (62%) agreed to participate, were block-randomized, showed up for the baseline measures, and constituted the intention-to-treat (ITT) sample ( n = 95 intervention group, n = 51 control group). In the intervention group, 70 (74%) downloaded the mobile application and completed the program (intervention per-protocol). Significant weight loss and BMI reduction were observed for both the intention-to-treat intervention group ( P < 0.05, P = 0.01) and the per-protocol intervention group ( P < 0.0001, P < 0.0001). For the intervention per-protocol group, the odds ratio of achieving 5% weight loss, compared to not treated per-protocol, was 3.3 (95% CI 1.3-8.2), adjusting for age and weight at baseline.Attendance to weekly coaching sessions decreased by 18% during the program in the control group while it increased by 3% amongst the per-protocol group ( P = 0.004). Conclusions: These preliminary findings support the benefit of a digital therapeutic to enhance weight reduction and attendance in a structured lifestyle change program. Larger trials of longer duration are needed to confirm these findings.

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Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial

F1000Research ◽

10.12688/f1000research.55619.1 ◽

2021 ◽

Vol 10 ◽

pp. 929

Author(s):

Nouran Hesham El-Sherazy ◽

Naglaa Samir Bazan ◽

Sara Mahmoud Shaheen ◽

Nagwa A. Sabri

Keyword(s):

Ascorbic Acid ◽

Critically Ill ◽

Critically Ill Patients ◽

Statistical Significance ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Control Groups ◽

The Absolute ◽

And Control

Background Antioxidants show nephroprotective effect against vancomycin associated nephrotoxicity (VAN) in animals. This study aimed to assess the ascorbic acid nephro-protective role against VAN clinically. Methods Forty-one critically ill patients were randomly assigned to one of two groups: intervention group (vancomycin IV plus ascorbic acid, n=21) or control group (vancomycin IV only, n=20). Primary outcomes were the incidence of VAN and the absolute change in creatinine parameters, while mortality rate was the secondary outcome. Nephrotoxicity was defined as an increase in serum creatinine (S.cr) by at least 0.5 mg/dL or 50% of baseline for at least two successive measurements. This study is registered at Clinicaltrials.gov (NCT03921099), April 2019. Results Mean absolute S.cr increase was significant when compared between both groups, P-value = 0.036, where S.cr increased by 0.05(0.12) and 0.34(0.55) mg/dL in the intervention and control groups, respectively. Mean absolute Cr.cl decline was significant when compared between both groups, P-value = 0.04, where Cr.cl was decreased by 5.9(17.8) and 22.3(30.4) ml/min in the intervention and control groups, respectively. Incidence of VAN was 1/21(4.7%) versus 5/20(25%) in the intervention and control groups, respectively (RR: 0.19; CI: 0.024–1.49; P-value = 0.093). Mortality was higher in the control group; however, it was not statistically significant, P-value = 0.141. Conclusion Co-administration of ascorbic acid with vancomycin preserved renal function and reduced the absolute risk of VAN by 20.3%, however, the reduction in VAN incidence didn’t reach statistical significance level. Further large multicenter prospective trials are recommended.

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Antibiotic Stewardship in Patients after Cellular Therapy with Febrile Neutropenia- a Single Center Prospective Unblinded Randomized Trial

Blood ◽

10.1182/blood-2021-152559 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 747-747

Author(s):

Ron Ram ◽

Odelia Amit ◽

Amos Adler ◽

Yael Bar-On ◽

Ofrat Beyar-Katz ◽

...

Keyword(s):

Febrile Neutropenia ◽

Antibiotic Stewardship ◽

Cellular Therapy ◽

Randomized Study ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Single Center ◽

Car T ◽

Empiric Antibiotic

Abstract Background: Neutropenic fever is a life-threatening condition which is common in patients undergoing allogeneic/autologous hematopoietic cell transplantation (HCT) or chimeric antigen receptor - T cell (CAR-T) therapy. Empirical treatment includes monotherapy with a beta-lactam containing anti-pseudomonal activity. Nevertheless, stewardship of antibiotic in this vulnerable population is controversial. Methods: This was a single center, prospective, unblinded randomized study, of patients after HCT or CAR-T therapy that were enrolled between January 2020 and March 2021. Allocation was concealed in sequentially numbered sealed opaque envelopes. All patients signed informed consent and the study was approved by the Tel Aviv Medical Center Institutional Review Board. Patients were randomly assigned to receive either standard empiric antibiotic ( piperacillin/tazobactam or ceftazidime) that was continued until recovery of counts (control group), or standard empiric antibiotic that was discontinued after 48-72 hours providing there was no evidence of clinical or microbiology documented infection (intervention group). Rapid identification of bloodstream infections was performed with BioFire filmarray multiplex PCR assay (bioMerieux), and results were used to adjust antibiotic treatment early. The primary outcome was the percentage of days without empiric antibiotic (antibiotic-free-neutropenia days). Secondary outcome included successful response to treatment, defined as the combination of- continuation of clinical improvement on day 5 after initiation of antibiotic, no reoccurrence of bacetermia/fever/clinical infection signs on day 5, and no need for additional therapy on day 4-5 after starting antibiotic. Breakthrough fever, death within 30 days of episode onset, duration of hospitalization, duration of neutropenia, graft vs. host disease (GVHD) and characteristics of cytokine release syndrome (CRS) were also evaluated, as appropriate. Results: 110 patients were randomized to standard therapy (control group, n=51) and antibiotic stewardship strategy (intervention group, n=59), Figure 1. The patients' baseline characteristics were well-balanced between the 2 groups, Table 1. Febrile neutropenia occurred in 91 of the patients, and these patients were eligible for the per-protocol analysis. In the intention-to-treat population, the fraction of antibiotic-free neutropenia days was significantly higher for patients allocated to the stewardship arm, compared to those allocated to the standard arm (median [IQR], 0.8 [0.62-0.86] versus 0.51 [0.17-0.86], respectively, p=.0016). This was also true for the subgroups of patients treated per-protocol (median [IQR], 0.75 [0.61-0.83] versus 0.42 [0.12-0.72], respectively, p<.001) and in the subgroups of patients after allogeneic HCT, autologous HCT and CAR-T therapy (0.75 [0.57-0.86] vs. 0.5 [0.40-0.51], p=.0046; 0.66 [0.62-0.83] vs. 0.59 [0.19-0.81], p=.077; and 0.7 [0.45-0.82] vs 0.06 [0-0.28], p=.025, respectively), Figure 2. There was no difference in the success rate between the 2 groups (84.7% vs. 78%, P =0.45). Thirty-day death rate was similarly low in both groups. Other outcome are depicted in Table 2. Linear regression was used to assess the interaction of patient and treatment variables with the fraction of antibiotic-free days. Assignment to the stewardship arm was significantly associated with a higher fraction of antibiotic-free days (p=.003), whereas CART treatment was associated with a lower fraction of antibiotic-free days (p=.004). Conclusions: This is the first randomized study showing in a homogenous population of patients after cellular therapy, the safety of antibiotic stewardship. Optimization of antibiotic schedule is a widely available and cost-effective strategy to improve treatment outcomes in patients with high risk febrile neutropenia after cellular therapy. Figure 1 Figure 1. Disclosures Ram: Gilead: Honoraria; Novartis: Honoraria. Avivi: Kite, a Gilead Company: Speakers Bureau; Novartis: Speakers Bureau.

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A Pilot Randomized Controlled Trial of a Preoperative Patient Education Intervention to Improve Satisfaction and Reduce Resource Utilization in Gynecologic Surgery

Current Opinion in Gynecology and Obstetrics ◽

10.18314/cogo.v1i1.1409 ◽

2018 ◽

Vol 1 (1) ◽

pp. 82-87

Author(s):

Alexandre Buckley de Meritens ◽

Caitlin Baptiste ◽

June Y Hou ◽

William M Burke ◽

Jason D Wright ◽

...

Keyword(s):

Patient Satisfaction ◽

Resource Utilization ◽

Educational Intervention ◽

Intervention Group ◽

Emergency Department Visits ◽

Gynecologic Surgery ◽

Control Group ◽

Phone Calls ◽

Communication Time ◽

Preoperative Patient

During the initial surgical consult patients may feel overwhelmed by the information they are given regarding their diagnosis and surgical plan. We looked to determine if a preoperative patient educational intervention would improve patient satisfaction and optimize use of medical services after discharge. Methods: We randomized women undergoing major gynecologic surgery by laparoscopy or laparotomy, to standard of care (Control) or a preoperative educational intervention. The pre-operative educational intervention consisted of: 1) a handout with information on inpatient and outpatient recovery and 2) a preoperative phone-call to review the handout and answer questions. At the post-operative visit, patients completed a Patient Satisfaction Questionnaire (PSQ-18), addressing satisfaction, interpersonal manner, communication, time spent with doctors and physician accessibility. The number of phone calls, emergency department visits and unscheduled post-operative clinic visits were quantified during the first 2 weeks after surgery. Descriptive statistics and t-tests were used for analysis.Results: 62 consecutive patients were randomized: 31 to intervention and 31 to the control group. Within the cohort 35 patients underwent laparoscopy and 21 laparotomy, 6 patients withdrew or cancelled their surgery. Forty postoperative patient satisfaction questionnaires were collected, 20 in the intervention group and 20 in the control group (response rate 71%). Intervention was associated to increased patient satisfaction. In the LSC group, the intervention improved patients’ perception of their physicians’ interpersonal manners, communication and time spent with the doctor (p < 0.05). Only one patient (3.5%) in the intervention group visited the ER post-operatively (laparotomy, wound separation) compared to 5 (17.8%) control patients (4 laparoscopy, 1 laparotomy, p < 0.05), all for minor complaints (pain, anxiety, incision).Conclusions: In our randomized trial this low-cost, feasible pre-operative educational intervention improves patients’ perception of their surgeons’ communication skills and decreased post-operative healthcare resource utilization. The effects are most pronounced in women undergoing minimally invasive surgery.

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The Effectiveness of a Healthcare Application and Human Coaching Program in Primary Care Clinics: A Non-randomized Controlled Trial (Preprint)

10.2196/preprints.34531 ◽

2021 ◽

Author(s):

HyoRim Ju ◽

EunKyo Kang ◽

YoungIn Kim ◽

HyunYoung Ko ◽

Belong Cho

Keyword(s):

Primary Care ◽

Weight Loss ◽

Sleep Quality ◽

Chronic Conditions ◽

Chronic Condition ◽

Intervention Group ◽

Self Management ◽

Control Group ◽

Primary Care Clinics ◽

Healthcare Application

BACKGROUND As the global burden of chronic conditions increases, effective management for these are a concern. There is an increasing need for chronic condition management using mobile self-management healthcare applications. OBJECTIVE This study evaluated the effectiveness of a mobile self-management healthcare application combined with human coaching for primary care services in patients with chronic conditions. METHODS A total of 110 patients with hypertension, diabetes, dyslipidemia, and/or metabolic syndrome who visited one of 17 participating primary care clinics from September 2020 to November 2020 were included in this study. Data regarding changes in body weight, sleep conditions, quality of life, depression, anxiety, stress, body mass index, waist circumference, blood sugar levels, blood pressure, and blood lipids levels were recorded. The intervention group (N=65) used a mobile self-management healthcare application with human coaching for 12 weeks, and the control group (N=45) underwent conventional, self-managed health care. RESULTS Patients in the intervention group reported significantly more weight loss than those in the control group (P=.002). The weight loss was markedly greater after using application for nine weeks than using it for four weeks or five to eight weeks (P=.002). Patients in the intervention group reported better sleep quality (P=.04) and duration (P=.004) than those in the control group. CONCLUSIONS The combination of a mobile self-management healthcare application and human coaching in primary care clinics results in better management of chronic conditions. The observed weight loss was greater and sleep quality improved than conventional primary care for patients with at least one chronic condition.

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Evaluating the effects of a mindfulness mobile application on student pharmacists’ stress, burnout, and mindfulness

American Journal of Health-System Pharmacy ◽

10.1093/ajhp/zxab467 ◽

2021 ◽

Author(s):

Angela Chu ◽

Tyler M Rose ◽

Danielle A Gundrum ◽

Tressa E McMorris ◽

Eytan A Klausner ◽

...

Keyword(s):

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Control Group ◽

Intervention Period ◽

Entire Study ◽

Positive Effects ◽

Waitlist Control Group

Abstract Disclaimer In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists’ perceived stress, burnout, and mindfulness. Methods This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. Results Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. Conclusion A mindfulness mobile application significantly improved student pharmacists’ stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

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Abstract WP221: Very Brief Intervention Improves Stroke Response in a Randomized Trial: Stroke Ready Very Brief Intervention

Stroke ◽

10.1161/str.51.suppl_1.wp221 ◽

2020 ◽

Vol 51 (Suppl_1) ◽

Author(s):

Lesli E Skolarus ◽

Maria Cielito Robles ◽

Springer Mellanie ◽

Chun Chieh Lin ◽

Casey Corches ◽

...

Keyword(s):

Brief Intervention ◽

Action Plan ◽

Controlled Trial ◽

Intervention Group ◽

Secondary Outcome ◽

Average Score ◽

Control Group ◽

Symptom Recognition ◽

Stroke Symptom ◽

One To One

Introduction: Stroke pre-hospital delay has not improved over time. Hypothesis: Stroke Ready, a very brief (5 minute), theory based, peer-led, stroke preparedness intervention, will increase stroke response compared with a control intervention. Methods: We performed a randomized, single-blind controlled trial among adults in Flint, MI. The stroke preparedness intervention group received a Stroke Ready pamphlet and action plan, while the control group received stroke prevention materials - both delivered during a one-to-one interaction with a trained peer educator. Research staff, blinded to group intervention assignment, assessed baseline and immediate post-intervention outcomes. Primary outcome was change in stroke response (behavioral intent to call 911) using a community-modified stroke action test (range 0-12). Secondary outcome was change in stroke symptom recognition (range 0-8). We conducted descriptive analyses and used a linear regression model to evaluate the effect of the intervention on stroke response after adjustment for pre-intervention intent, age, education, race, marital status, history of stroke, stroke in someone they know and psychological constructs. Results: We enrolled 129 participants (74 intervention; 55 control). Mean age was 60 years (SD 14); 61% were women, 89% were African American and 19% were not high school graduates. Intervention participants had greater improvement in stroke response than control participants (figure 1), which remained after full adjustment (improvement in average score for stroke response was 1.7 higher in intervention participants than control participants, 95% CI 0.9-2.5, p<0.0001). There was no difference in stroke symptom recognition (figure 1). Conclusion: The Stroke Ready very brief intervention increased stroke response. This new approach using a very brief, one-to-one interaction with trained peer educators is a promising, scalable, intervention to increase stroke response.

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Effectiveness of a primary care-based group educational intervention in the management of patients with migraine: a randomized controlled trial

Primary Health Care Research & Development ◽

10.1017/s1463423619000720 ◽

2019 ◽

Vol 20 ◽

Cited By ~ 1

Author(s):

Iñaki Aguirrezabal ◽

Maria Soledad Pérez de San Román ◽

Raquel Cobos-Campos ◽

Estibalitz Orruño ◽

Arturo Goicoechea ◽

...

Keyword(s):

Primary Care ◽

Educational Intervention ◽

Controlled Trial ◽

Basque Country ◽

Intervention Group ◽

Cost Effective ◽

Response To Treatment ◽

Secondary Outcome ◽

Control Group ◽

Randomised Controlled

Abstract Aim: The aim of this study was to assess the effectiveness of a primary care-based group educational intervention about concepts of pain neuroscience for the management of migraine compared to the routine medical care delivered to patients with this condition. Background: The way pain is understood has been radically changed in recent decades, thanks to developments in the field of neuroscience. Thus, migraine may develop as a result of an exaggerated perception of threat that activates the pain neuromatrix, which might be modifiable, from a learning perspective, by adjusting the beliefs and behaviours that favour the onset of an attack. Methods: A randomised controlled trial was carried out in five primary care health centres of Vitoria-Gasteiz (Basque Country, Spain). The follow-up period was 12 months. The main outcome measure was the reduction in days lost due to migraine-related disability according to the Migraine Disability Assessment Test (MIDAS) score. Secondary outcome measures included the intensity and frequency of the pain and the number of analgesic drugs taken in the previous three months. A positive response to treatment was considered when the MIDAS score decreased by at least 50% from baseline. Findings: Days lost due to migraine-related disability decreased by at least 50% in 68.9% (n = 37) of patients in the intervention group and 34.6% of patients in the control group (n = 18) (P < 0.001). The intensity of the headache [odds ratio (OR) 9.116; P = 0.005] and the medication intake (OR 13.267; P < 0.001) were also significantly reduced with the intervention. Conclusions: The provision of suitable information through a group educational intervention delivered in primary care appears to be effective in preventing migraine attacks. Moreover, the intervention could offer a new cost-effective management alternative that seems to reduce the need for pharmacological treatment in patients with migraine.

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Platelet Functions are Decreased in Obesity and Restored after Weight Loss: Evidence for a Role of the SERCA3-Dependent ADP Secretion Pathway

Thrombosis and Haemostasis ◽

10.1055/s-0038-1677033 ◽

2019 ◽

Vol 119 (03) ◽

pp. 384-396 ◽

Cited By ~ 3

Author(s):

Ziane Elaïb ◽

Jose Lopez ◽

Muriel Coupaye ◽

Kevin Zuber ◽

Yann Becker ◽

...

Keyword(s):

Weight Loss ◽

Gastric Bypass Surgery ◽

Calcium Signalling ◽

Adenosine Diphosphate ◽

Control Group ◽

Obese Patients ◽

Secretion Pathway ◽

Healthy Control ◽

Platelet Functions

AbstractIn obesity, platelets are described as hyperactive, mainly based on increased platelet size and presence of pro-thrombotic plasmatic molecules. We explored platelet functions, including calcium signalling in obesity, and the effect of weight loss. We included 40 obese patients (women with body mass index [BMI] of ≥ 35 kg/m2) who were to undergo gastric bypass surgery and 40 healthy lean subjects (women with BMI of < 25 kg/m2) as a control group. Approximately 1 year after surgery, the obese patients lost weight (75% had a BMI < 35 kg/m2). They were explored a second time with the same healthy control for the same platelet experiments. Compared with controls, obese patients' platelets displayed reduced sensitivity to thrombin (aggregation EC50 increased by 1.9 ± 0.3-fold, p = 0.005) and a lower Ca2+ response (70 ± 7% decrease, p < 10−4). In 17 pairs of patients, we performed additional experiments: in obese patients' platelets, thrombin-induced αIIbβ3 activation was significantly lower (p = 0.003) and sarco-endoplasmic reticulum Ca2+ATPase (SERCA3) expression was decreased (48 ± 6% decrease, p < 10−4). These differences were abolished after weight loss. Interestingly, pharmacological inhibition of SERCA3 activity in control group's platelets mimicked similar alterations than in obese patients' platelets and was associated with defective adenosine diphosphate (ADP) secretion. Addition of ADP to agonist restored platelet functions in obese patients and in SERCA3-inhibited control platelets (five experiments) confirming the direct involvement of the SERCA3-dependent ADP secretion pathway. This is the first study demonstrating that platelets from obese patients are hypo-reactive, due to a deficiency of SERCA3-dependent ADP secretion. Weight loss restores SERCA3 activity and subsequent calcium signalling, αIIbβ3 activation, platelet aggregation and ADP secretion.

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Results of the Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) Trial: A Behavioral Weight Loss Intervention in Overweight or Obese Breast Cancer Survivors

Journal of Clinical Oncology ◽

10.1200/jco.2015.61.1095 ◽

2015 ◽

Vol 33 (28) ◽

pp. 3169-3176 ◽

Cited By ~ 98

Author(s):

Cheryl L. Rock ◽

Shirley W. Flatt ◽

Tim E. Byers ◽

Graham A. Colditz ◽

Wendy Demark-Wahnefried ◽

...

Keyword(s):

Breast Cancer ◽

Blood Pressure ◽

Weight Loss ◽

Breast Cancer Mortality ◽

Intervention Group ◽

Good Health ◽

Control Group ◽

Weight Loss Intervention ◽

Behavioral Weight Loss ◽

Behavioral Weight Loss Intervention

Purpose Obesity increases risk for all-cause and breast cancer mortality and comorbidities in women who have been diagnosed and treated for breast cancer. The Exercise and Nutrition to Enhance Recovery and Good Health for You (ENERGY) study is the largest weight loss intervention trial among survivors of breast cancer to date. Methods In this multicenter trial, 692 overweight/obese women who were, on average, 2 years since primary treatment for early-stage breast cancer were randomly assigned to either a group-based behavioral intervention, supplemented with telephone counseling and tailored newsletters, to support weight loss or a less intensive control intervention and observed for 2 years. Weight and blood pressure were measured at 6, 12, 18, and 24 months. Longitudinal mixed models were used to analyze change over time. Results At 12 months, mean weight loss was 6.0% of initial weight in the intervention group and 1.5% in the control group (P < .001). At 24 months, mean weight loss in the intervention and control groups was 3.7% and 1.3%, respectively (P < .001). Favorable effects of the intervention on physical activity and blood pressure were observed. The weight loss intervention was more effective among women older than 55 years than among younger women. Conclusion A behavioral weight loss intervention can lead to clinically meaningful weight loss in overweight/obese survivors of breast cancer. These findings support the need to conduct additional studies to test methods that support sustained weight loss and to examine the potential benefit of intentional weight loss on breast cancer recurrence and survival.

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