scholarly journals SUN-LB113 A Continuous Remote Care Intervention Utilizing Carbohydrate Restriction Including Nutritional Ketosis Improves Markers of Metabolic Risk and Reduces Diabetes Medication Use in Patients With Type 2 Diabetes Over 3.5 Years

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Amy McKenzie ◽  
Shaminie Athinarayanan ◽  
Rebecca Adams ◽  
Jeff Volek ◽  
Stephen Phinney ◽  
...  

Abstract Novel lifestyle, pharmaceutical, and/or surgical therapies for type 2 diabetes (T2D) are under study to assess lasting impact on metabolic risk. Among them, carbohydrate restriction including nutritional ketosis (CR) has emerged as a safe and effective nutrition therapy for reducing hyperglycemia in patients with T2D1, yet longer term effects are unknown. At the conclusion of a 2-year study assessing a continuous remote care intervention utilizing CR (CCI) among patients who selected this therapy, intervention participants were offered the opportunity to consent to participate in a 3-year extension assessing outcomes at 3.5- and 5-y following initial enrollment. 143 of 169 extension-consented participants provided data at 3.5-y follow up. Among 3.5-y completers, linear mixed effects models were used to assess change over time in diabetes-related outcomes and McNemar’s tests were used to assess for a difference in the proportion of participants meeting certain criteria at baseline compared to follow-up. At enrollment, 3.5-y completers were (mean±SE) 55±1 y of age, 40.8±0.7 kg/m2, and 8±1 y since diagnosis. Following treatment with the CCI for 3.5 y, significant improvements compared to baseline were observed in HbA1c (-0.6±0.1 from 7.4±0.1%; P = 1.9x10-5), weight (-10.9±1.1 from 117.4 kg; P = 6.9x10-17), nonHDL-C (-10±4 from 139±3 mg/dL; P = 0.005), triglycerides (-41±11 from 189±10 mg/dl; P = 2.1x10-4), and HDL-C (+9±1 from 43±1 mg/dl; P = 3.0x10-11); total cholesterol and LDL-C were statistically unchanged. The percentage of participants prescribed diabetes medication decreased from 84.6 to 67.1% (P = 5.0x10-6), while 50.2% of diabetes medications and 71.4% of diabetes medications other than metformin were discontinued. The percentage of participants treated with no pharmaceuticals or monotherapy increased from 52.5 to 81.9% (P = 1.3x10-8). 45.5% (65/143) of participants achieved HbA1c <6.5% with either no medication (34/65, 52%) or only metformin (31/65, 48%) at 3.5 y; 37.8% of participants maintained this status from 1 through 3.5 y of treatment. 22% of participants achieved diabetes remission at 3.5 y, and 17.5% of participants maintained remission status from 2 through 3.5 y of treatment. This demonstrates that clinically meaningful improvements across multiple markers of metabolic risk can be sustained in patients with T2D who selected treatment with this CCI for 3.5 y. Improvements in metabolic risk markers reduced the need for diabetes medication, allowing some patients to achieve and sustain diabetes remission. This ongoing trial will assess 5-y effects. 1. American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care. 2020; 43(Supplement 1): S48-S65. 2. Athinarayanan SJ, et al. Front Endocrinol. 2019; 10:348.

2021 ◽  
Author(s):  
Kajsa Sjöholm ◽  
Lena MS Carlsson ◽  
Per-Arne Svensson ◽  
Johanna C. Andersson-Assarsson ◽  
Felipe Kristensson ◽  
...  

<b>OBJECTIVE</b> <p>Obesity and type 2 diabetes are associated with serious, adverse health effects, including cancer. Although bariatric surgery has been shown to reduce cancer risk in patients with obesity, the effect of bariatric surgery on cancer risk in patients with obesity and diabetes is less studied. We therefore examined the long-term incidence of cancer after bariatric surgery and usual care in patients with obesity and diabetes in the matched prospective Swedish Obese Subjects (SOS) study. </p> <p><b>RESEARCH DESIGN AND METHODS</b></p> <p>The SOS study examines long-term outcomes following bariatric surgery or usual care. The current analysis includes 701 patients with obesity and type 2 diabetes at baseline, 393 of which underwent bariatric surgery, and 308 who received conventional obesity treatment. Information on cancer events was obtained from the Swedish National Cancer Register. Median follow-up time was 21.3 years (interquartile range 17.6-24.8 years, maximum 30.7 years). </p> <p><b>RESULTS</b></p> <p>During follow-up, the incidence rate for first-time cancer was 9.1 per 1000-person-years (95% CI, 7.2-11.5) in patients with obesity and diabetes treated with bariatric surgery and 14.1 per 1000-person-years (95% CI, 11.2-17.7) in patients treated with usual obesity care (HRadj=0.63; 95% CI 0.44-0.89, p=0.008). Moreover, surgery was associated with reduced cancer incidence in women (HRadj=0.58; 0.38-0.90, p=0.016), although the sex-treatment interaction was non-significant (p=0.630). In addition, diabetes remission at the 10-year follow-up was associated with reduced cancer incidence (HRadj=0.40; 95% CI 0.22-0.74, p=0.003).</p> <p><b>CONCLUSIONS</b></p> <p>These results suggest that bariatric surgery prevents cancer in patients with obesity and diabetes, and that durable diabetes remission is associated with reduced cancer risk. </p>


2021 ◽  
Author(s):  
Kajsa Sjöholm ◽  
Lena MS Carlsson ◽  
Per-Arne Svensson ◽  
Johanna C. Andersson-Assarsson ◽  
Felipe Kristensson ◽  
...  

<b>OBJECTIVE</b> <p>Obesity and type 2 diabetes are associated with serious, adverse health effects, including cancer. Although bariatric surgery has been shown to reduce cancer risk in patients with obesity, the effect of bariatric surgery on cancer risk in patients with obesity and diabetes is less studied. We therefore examined the long-term incidence of cancer after bariatric surgery and usual care in patients with obesity and diabetes in the matched prospective Swedish Obese Subjects (SOS) study. </p> <p><b>RESEARCH DESIGN AND METHODS</b></p> <p>The SOS study examines long-term outcomes following bariatric surgery or usual care. The current analysis includes 701 patients with obesity and type 2 diabetes at baseline, 393 of which underwent bariatric surgery, and 308 who received conventional obesity treatment. Information on cancer events was obtained from the Swedish National Cancer Register. Median follow-up time was 21.3 years (interquartile range 17.6-24.8 years, maximum 30.7 years). </p> <p><b>RESULTS</b></p> <p>During follow-up, the incidence rate for first-time cancer was 9.1 per 1000-person-years (95% CI, 7.2-11.5) in patients with obesity and diabetes treated with bariatric surgery and 14.1 per 1000-person-years (95% CI, 11.2-17.7) in patients treated with usual obesity care (HRadj=0.63; 95% CI 0.44-0.89, p=0.008). Moreover, surgery was associated with reduced cancer incidence in women (HRadj=0.58; 0.38-0.90, p=0.016), although the sex-treatment interaction was non-significant (p=0.630). In addition, diabetes remission at the 10-year follow-up was associated with reduced cancer incidence (HRadj=0.40; 95% CI 0.22-0.74, p=0.003).</p> <p><b>CONCLUSIONS</b></p> <p>These results suggest that bariatric surgery prevents cancer in patients with obesity and diabetes, and that durable diabetes remission is associated with reduced cancer risk. </p>


2020 ◽  
Vol 9 (4) ◽  
pp. 1070
Author(s):  
Ana de Hollanda ◽  
Albert Lecube ◽  
Miguel Angel Rubio ◽  
Enric Sánchez ◽  
Núria Vilarrasa ◽  
...  

Almost one third of patients do not achieve type 2 diabetes remission after bariatric surgery or are unable to sustain this effect long term. Our objective was to delve further into the dynamic responses of diabetes after bariatric surgery and to evaluate the “time-within-remission range” as a variable of metabolic control. A descriptive cohort study was done using a computerised multicentre and multidisciplinary registry. All data were adjusted by propensity score. A total of 1186 subjects with a follow-up of 4.5 ± 2.5 years were included. Type of surgery, diabetes remission, recurrence of diabetes, “time-within-remission range” and key predictors of diabetes outcomes were assessed. All patients (70% women, 51.4 ± 9.2 years old, body mass index (BMI) 46.3 ± 6.9 kg/m2) underwent primary bariatric procedures. “Time-within-remission range” were 83.3% (33.3–91.6) after gastric bypass, 68.7% (7.1–87.5) after sleeve gastrectomy and 90% (83.3–92.8) after malabsorptive techniques (p < 0.001 for all). Duration of diabetes, baseline HbA1c and insulin treatment were significantly negatively correlated with the “time-within-remission range”. The association of bariatric techniques with “time-within-remission range”, using gastric bypass as a reference, were: odds ratio (OR) 3.70 (2.34–5.84), p < 0.001 for malabsorptive techniques and OR 0.55 (0.40–0.75), p < 0.001 for sleeve gastrectomy. Characteristics of type 2 diabetes powerfully influence the outcomes of bariatric surgery. The “time-within-remission range” unveils a superiority of gastric bypass compared to sleeve gastrectomy.


2021 ◽  
pp. 089011712110244
Author(s):  
Ming Chen ◽  
Satya Surbhi ◽  
James E. Bailey

Purpose: To examine the association between weight loss and type 2 diabetes remission among vulnerable populations living in medically underserved areas of the Mid-Southern United States. Design: Quantitative, retrospective cohort study. Setting: 114 ambulatory sites and 5 adults’ hospitals in the Mid-South participating in a regional diabetes registry. Participants: 9,900 adult patients with type 2 diabetes, stratified by remission status, with 1 year of baseline electronic medical record data, and 1 year of follow-up data for the 2015-2018 study period. Measures: The outcomes were diabetes remissions, categorized as any remission, partial remission, and complete remission based on the guidelines of the American Diabetes Association. The exposure was weight loss, calculated by the change in the Body Mass Index (BMI) as a proxy measure. Analysis: χ2 tests, Fisher’s exact tests, and the Mann-Whitney U-test were used to examine the differences in patient characteristics by remission status across the 3 remission categories, as appropriate. Multiple multivariable logistic regressions adjusting for confounders were performed to estimate the adjusted odds ratios (aORs) for the associations between weight loss and diabetes remission. Results: Among 9,900 patients identified, a reduction of 0.3 kg/m2 (standard deviation: 2.5) in the average BMI from the baseline to the follow-up was observed. 10.8% achieved any type of remission, with 9.8% for partial and 1.0% for complete remissions. Greater weight loss was significantly associated with an increased likelihood of any (aOR = 1.07, 95% confidence interval (CI), 1.06-1.08), partial (aOR 1.06, 95% CI, 1.04-1.07), and complete diabetes remission (aOR 1.10, 95% CI, 1.07-1.13). Conclusions: Weight loss is significantly associated with diabetes remission among patients living in medically underserved areas, but complete remission is rare.


2020 ◽  
Author(s):  
Kajsa Sjöholm ◽  
Lena MS Carlsson ◽  
Magdalena Taube ◽  
Carel W le Roux ◽  
Per-Arne Svensson ◽  
...  

<b>Objective </b>Bariatric surgery is associated with diabetes remission and prevention of diabetes-related complications. The scores ABCD, DiaRem, Ad-DiaRem, DiaBetter and IMS were developed to predict short to medium-term diabetes remission after bariatric surgery. However, they have not been tested for predicting durable remission nor the risk of diabetes complications, nor compared with diabetes duration alone. <p><b>Research Design and Methods </b>We identified 363<b> </b>individuals from the surgically treated group in the prospective Swedish Obese Subjects (SOS) study with preoperative type 2 diabetes and for whom data (preoperative age, BMI, C-peptide, HbA1c, oral diabetes medication(s), insulin use, and diabetes duration) were available for calculation of remission scores. Partial remission (after 2 and 10 years) was defined as blood glucose <6.1 mmol/L or HbA1c <6.5% (48 mmol/mol) and no diabetes medication. Information on diabetes complications (at baseline and over 15 years of follow-up) was obtained from national health registers. Discrimination was evaluated by area under receiving operator characteristic curves (AUROCs).</p> <p><b>Results </b>For 2-year diabetes remission, AUROCs were between 0.79 and 0.88 for remission scores and 0.84 for diabetes duration alone. After 10 years, the predictive ability of scores decreased markedly (AUROCs between 0.70-0.76) and no score had higher predictive capacity than diabetes duration alone (AUROC=0.73). For development of microvascular and macrovascular diabetes complications over 15 years, AUROCs for remission scores were 0.70-0.80 and 0.62-0.71, respectively, and AUROCs for diabetes duration alone were 0.77 and 0.66, respectively. </p> <b>Conclusions </b>Remission scores and diabetes duration are good predictors of short-term diabetes remission. However, for durable remission and risk of complications, remission scores and diabetes duration alone have limited predictive ability.


2016 ◽  
Vol 29 (suppl 1) ◽  
pp. 102-106 ◽  
Author(s):  
Josemberg CAMPOS ◽  
Almino RAMOS ◽  
Thomaz SZEGO ◽  
Bruno ZILBERSTEIN ◽  
Heládio FEITOSA ◽  
...  

ABSTRACT Introduction Even considering the advance of the medical treatment in the last 20 years with new and more effective drugs, the outcomes are still disappointing as the control of obesity and type 2 Diabetes Mellitus (T2DM) with a large number of patients under the medical treatment still not reaching the desired outcomes. Objective: To present a Metabolic Risk Score to better guide the surgical indication for T2DM patients with body mass index (BMI) where surgery for obesity is still controversial. Method: Research was conducted in Pubmed, Medline, Pubmed Central, Scielo and Lilacs between 2003-2015 correlating headings: metabolic surgery, obesity and type 2 diabetes mellitus. In addition, representatives of the societies involved, as an expert panel, issued opinions. Results: Forty-five related articles were analyzed by evidence-based medicine criteria. Grouped opinions sought to answer the following questions: Why metabolic and not bariatric surgery?; Mechanisms involved in glycemic control; BMI as a single criterion for surgical indication for uncontrolled T2DM; Results of metabolic surgery studies in BMI<35 kg/m2; Safety of metabolic surgery in patients with BMI<35 kg/m2; Long-term effects of surgery in patients with baseline BMI<35 kg/m2 and Proposal for a Metabolic Risk Score. Conclusion: Metabolic surgery has well-defined mechanisms of action both in experimental and human studies. Gastrointestinal interventions in T2DM patients with IMC≤35 kg/m2 has similar safety and efficacy when compared to groups with greater BMIs, leading to the improvement of diabetes in a superior manner than clinical treatment and lifestyle changes, in part through weight loss independent mechanisms . There is no correlation between baseline BMI and weight loss in the long term with the success rate after any surgical treatment. Gastrointestinal surgery treatment may be an option for patients with T2DM without adequate clinical control, with a BMI between 30 and 35, after thorough evaluation following the parameters detailed in Metabolic Risk Score defined by the surgical societies. Roux-en-Y gastric bypass (RYGB), because of its well known safety and efficacy and longer follow-up studies, is the main surgical technique indicated for patients eligible for surgery through the Metabolic Risk Score. The vertical sleeve gastrectomy may be considered if there is an absolute contraindication for the RYGB. T2DM patients should be evaluated by the multiprofessional team that will assess surgical eligibility, preoperative work up, follow up and long term monitoring for micro and macrovascular complications.


2020 ◽  
Author(s):  
Magdalena Mizera ◽  
Michał Wysocki ◽  
Katarzyna Bartosiak ◽  
Paula Franczak ◽  
Hady Razak Hady ◽  
...  

Abstract Purpose Bariatric surgery is no longer considered only as a weight loss surgery but also a way of treating obesity-related comorbidities such as type 2 diabetes mellitus (T2DM). Short-term T2DM remissions in patients undergoing laparoscopic sleeve gastrectomy (LSG) have been shown, but there are very few reports on the mid-term results. We aimed to assess the remission rate of T2DM in obese patients after LSG throughout 5-year follow-up. Materials and Methodology We performed a retrospective multicenter cohort analysis of 240 patients who underwent LSG. We assessed the remission rate of T2DM 1 year and 5 years after surgery. Results Forty-six percent of patients achieved T2DM remission 5 years after LSG. The remission group had better weight loss results (median% of total weight loss 5 years after: 30.1% (22.9–37.0) vs 23.0% (13.7–30.2), p < 0.001) and were significantly younger than the no remission group (43 (38–52) vs 52 (44–58) years, p < 0.001). Duration of T2DM was significantly shorter (2 (1–5) vs 5 (3–10) years, p < 0.001) with less insulin requirement and less diabetes-related complications (7.2% vs 19.8%, p < 0.001) and significantly lower median DiaRem score (4.0 (IQR 2.0–6.0) vs 12.0 (IQR 5.0–16.0), p < 0.001). Preoperative body mass index (BMI) had no effect on remission. Conclusions Our study suggests that diabetes remission after laparoscopic sleeve gastrectomy occurs frequently, and in the 5-year follow-up, it may remain at the level of 46%. We identified the age of patients, duration, and severity of T2DM as factors affecting mid-term diabetes remission. Nevertheless, further well-designed trials are needed to support our findings.


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