scholarly journals Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: A double-blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hadi Bazyar ◽  
Ahmad Zare Javid ◽  
Hossein Bavi Behbahani ◽  
Fardin Moradi ◽  
Bahman Moradi Poode ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Anthropometric Indices ◽  
Double Blind ◽  
Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for eight weeks. Mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHR) were evaluated in all the patients pre- and post-intervention.Results: Melatonin supplementation for eight weeks significantly decreased the mean levels of MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHR post-intervention (p<0.05). Also, the median changes of MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p<0.05). A significant increase (p<0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p<0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

scholarly journals Consumption of melatonin supplement improves cardiovascular disease risk factors and anthropometric indices in type 2 diabetes mellitus patients: a double-blind, randomized, placebo-controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hadi Bazyar ◽  
Ahmad Zare Javid ◽  
Hossein Bavi Behbahani ◽  
Fardin Moradi ◽  
Bahman Moradi Poode ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Anthropometric Indices ◽  
Double Blind ◽  
Conicity Index

Abstract Background Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications that may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. This study investigated the effects of melatonin supplementation on some cardiovascular disease risk factors and anthropometric indices in patients with type 2 diabetes mellitus (T2DM). Materials and methods In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups which received two tablets of either melatonin or placebo (250 mg) once a day for 8 weeks. Systolic blood pressure (SBP), mean arterial pressure (MAP), pulse pressure (PP), the atherogenic index of plasma (AIP), weight, body mass index (BMI), waist and hip circumference (WC, HC), a body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist-to-height ratio (WHtR) were evaluated in all the patients pre- and post-intervention. Results Melatonin supplementation for 8 weeks significantly decreased the mean levels of SBP, MAP, PP, weight, BMI, WC, HC, BAI, AVI, conicity index, and WHtR post-intervention (p <  0.05). Also, the median changes of SBP, MAP, PP, weight, BMI, WC, HC BAI, AVI, and conicity index were significantly lower in the intervention group compared with the control group (p <  0.05). A significant increase (p <  0.001) was observed in the mean levels of ABSI in the intervention group. The median changes of ABSI were significantly greater in the intervention group compared with the control group (p <  0.001). Conclusions Consumption of melatonin supplement may be effective in controlling arterial pressure including SBP, MAP, and PP and anthropometric indices (as predictors of obesity) in T2DM patients. Trial registration Iranian Registry of Clinical Trials IRCT20190303042905N1. Registered on 17 May 2019.

scholarly journals Consumption of melatonin supplement improves cardiovascular disease risk factors and new anthropometric indices (as predictors of obesity) in type 2 diabetes mellitus patients: A double–blind, randomized, placebo-controlled trial

2020 ◽  
Author(s):  
Hadi Bazyar ◽  
Ahmad Zare Javid ◽  
Hossein Bavi Behbahani ◽  
Fardin Moradi ◽  
Bahman Moradi Poode ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Control Group ◽  
Anthropometric Indices ◽  
Double Blind ◽  
The Mean ◽  
Conicity Index

Abstract Background: Diabetes mellitus is a common chronic disease. Dyslipidemia and hypertension are two complications may develop in diabetic patients if hyperglycemia, insulin resistance, and weight gain are not controlled. The objective of this study was to investigate the effects of melatonin supplementation on some cardiovascular disease risk factors and new anthropometric indices in patients with type 2 diabetes mellitus (T2DM).Materials and Methods: In this double-blind, randomized, placebo-controlled trial, 50 T2DM patients were randomly allocated to intervention and control groups. The intervention and control groups received either 2 tablets melatonin or placebo (250 mg) once a day for 8 weeks. Mean arterial pressure (MAP), pulse pressure (PP), atherogenic index of plasma (AIP), body shape index (ABSI), abdominal volume index (AVI), body adiposity index (BAI), lipid accumulation product (LAP), conicity index, and waist to height ratio (WHR) were evaluated in all patients pre and post-intervention.Results: Melatonin supplementation for 8 weeks significantly decreased the mean levels of MAP, PP, BAI, AVI, conicity index, and WHR post intervention (p <0.05). Also, the mean changes of MAP, PP, BAI, AVI, and Conicity index were significantly lower in the intervention group compared with the control group (p <0.05). A significant increase (p <0.001) was observed in the mean levels of ABSI in the intervention group. The mean changes of ABSI was significantly greater in the intervention group compared with the control group (p <0.001).Conclusions: Consumption of melatonin supplement may be effective in controlling arterial pressure and new anthropometric indices (as predictors of obesity) in T2DM patients.Trial registration: This trial was registered in the Iranian Registry of Clinical Trials website at 2019/5/17. (IRCT20190303042905N1).

scholarly journals A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial

2021 ◽  
Author(s):  
Joseph Keawe'aimoku Kaholokula ◽  
Mele Look ◽  
Tricia Mabellos ◽  
Hyeong Jun Ahn ◽  
So Yung Choi ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Randomized Controlled Trial ◽  
Disease Risk ◽  
Controlled Trial ◽  
Cardiovascular Disease Risk ◽  
Intervention Group ◽  
Native Hawaiians ◽  
Control Group ◽  
Cvd Risk ◽  
Randomized Controlled

Abstract Background Native Hawaiians have higher hypertension (HTN) and cardiovascular disease (CVD) rates than non-Hispanic whites, calling for culturally responsive interventions to close this gap. Purpose We tested the effects of a 6-month behavioral intervention, a cultural dance program based on hula (the customary dance of Hawai'i), for improving blood pressure (BP) and CVD risk among Native Hawaiians with uncontrolled HTN. Methods In a randomized controlled trial, we tested the effects of the hula-based intervention among 263 Native Hawaiians with uncontrolled HTN (systolic ≥ 140 or ≥ 130 mmHg if diabetes) and no CVD at enrollment. All participants received a brief culturally tailored heart health education before random assignment to the hula-based intervention (n = 131) or the education-only waitlist control (n = 132). Intervention received hula lessons and group-based activities for 6 months. Control received only 1-week education through 6 months. Results Intervention yielded greater reductions in systolic (−15.3 mmHg) and diastolic (−6.4 mmHg) BP than control (−11.8 and −2.6 mmHg, respectively) from baseline to 6 months (p &lt; .05). At 6 months, 43% of intervention participants compared to 21% of controls achieved a HTN stage &lt;130/80 mmHg (p &lt; .001). The 10-year CVD risk reduction was two times greater for the intervention group than the control group based on the Framingham Risk Score calculator. All improvements for intervention participants were maintained at 12 months. Conclusions This trial represents one of the few rigorously conducted examinations of an Indigenous practice leveraged for health promotion, with implications for other ethnic populations.

scholarly journals Influence of physical activity on periodontal health in patients with type 2 diabetes mellitus. A blinded, randomized, controlled trial

2021 ◽  
Author(s):  
K. Wernicke ◽  
J. Grischke ◽  
M. Stiesch ◽  
S. Zeissler ◽  
K. Krüger ◽  
...  
Keyword(s):  
Physical Activity ◽  
Diabetes Mellitus ◽  
Type 2 Diabetes ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Periodontal Health ◽  
Randomized Controlled ◽  
Hba1c Levels

Abstract Objectives The aim was to investigate the effect of physical activity on periodontal health and HbA1c levels in patients with type 2 diabetes mellitus (T2DM) over a period of 6 months. Materials and methods Thirty-seven patients with non-insulin-dependent T2DM were included in the study. The intervention group (n=20) performed physical activity over a period of 6 months. The control group (n=17) did not receive any intervention. Baseline and final examinations included dental parameters and concentrations of glycosylated hemoglobin (HbA1c) and high-sensitivity C-reactive protein (hsCRP). Results Physical activity showed a positive effect on periodontal health. Both the BOP (p= 0.005) and the severity of periodontitis (p= 0.001) were significantly reduced in the intervention group compared to the control group. Furthermore, HbA1c levels were reduced (p= 0.010) significantly in the intervention group while hsCRP levels significantly increased in the control group (p= 0.04). Conclusions Within the limitations of this randomized, controlled trial, physical activity over a period of 6 months is a health-promoting measure for patients with T2DM and improves both periodontal health and HbA1c concentrations.

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

scholarly journals Equol effects on AGE skin products, visceral fat and climacteric symptoms in post-menopausal women: A randomized controlled trial

2021 ◽  
Author(s):  
Remi Yoshikata ◽  
Khin Zay Yar Myint ◽  
Hiroaki Ohta ◽  
Yoko Ishigaki
Keyword(s):  
Randomized Controlled Trial ◽  
Visceral Fat ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Climacteric Symptoms ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Menopausal Women ◽  
Post Menopausal

Abstract Introduction: Equol, an isoflavone derivative whose chemical structure is similar to estrogen, is considered as a potentially effective agent for relieving climacteric symptoms, for the prevention of the lifestyle-related diseases, and for aging care in post-menopausal women. We investigated the effect of an equol-containing supplement on metabolism and aging, and climacteric symptoms, with respect to internally-produced equol in post-menopausal women.Methods: A single center, randomized controlled trial (registration number: UMIN000030975) on 57 post-menopausal Japanese women (mean age: 56±5.37 years), was conducted. Twenty-seven women received the equol supplement, while the remaining received Control. Metabolic and aging-related biomarkers were compared before and after the 3-month intervention. Climacteric symptoms were assessed every month using a validated self-administered questionnaire in Japanese post-menopausal women. Results: Three months post intervention, the treatment group showed significant improvement in climacteric symptoms, when compared to the Control group (81% vs. 53% respectively, p=0.045). We did not observe any beneficial effect on metabolic and aging-related biomarkers in the intervention group. However, in certain populations significant improvement in skin auto-fluorescence, which is a measurement of AGE skin products, and visceral fat area was observed, especially among equol producers. Conclusion: Women receiving equol supplement showed improved climacteric symptoms. This study offered a new hypothesis that there may be a synergy between supplemented equol and endogenously-produced equol to improve skin aging and visceral fat in certain populations.

scholarly journals Efficacy of an Objective Structured Clinical Examination Training Approach for Training Pharmacy Students in Diabetes Mellitus Counseling: A Randomized Controlled Trial

Pharmacy ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 229
Author(s):  
Imaneh Farahani ◽  
Samieh Farahani ◽  
Maira A. Deters ◽  
Holger Schwender ◽  
Stephanie Laeer
Keyword(s):  
Diabetes Mellitus ◽  
Communication Skills ◽  
Controlled Trial ◽  
Objective Assessment ◽  
Intervention Group ◽  
Pharmacy Students ◽  
Controlled Study ◽  
Control Group ◽  
Randomized Controlled ◽  
Training Approach

Pharmacists’ tasks are multifaceted and include, for example, vital counseling and communication skills. Objective Structured Clinical Examinations (OSCEs) could be used to train pharmacy students in these skills. Our study sought to determine the efficacy of our OSCE training approach for training pharmacy students’ counseling and communication skills on diabetes mellitus compared to a control group. This randomized controlled study was conducted with pharmacy students using a pre-post-design. The intervention group completed diabetes OSCE training, while the control group solved diabetes patient cases using subjective, objective, assessment, and plan notes. Before and after the respective training, both groups completed OSCEs evaluating counseling and communication skills. Before each OSCE encounter, the participants completed a self-assessment questionnaire and, upon completion of the seminar, filled out a satisfaction survey. The OSCE-trained group demonstrated a significantly greater increase in counseling and communication skills and self-confidence than the control group. Both groups were generally satisfied with the seminar. These results demonstrate that our OSCE training approach allows for the effective training of pharmacy students’ diabetes counseling and communication skills and suggests the inclusion of such a skill-based approach more widely in pharmacy students’ education.

scholarly journals Effectiveness of hamstring stretching using a pressure biofeedback unit for 4 weeks: A randomized controlled trial

2020 ◽  
Vol 40 (02) ◽  
pp. 99-107
Author(s):  
Jin-Oh Ahn ◽  
Jong-Hyuck Weon ◽  
Eun-Kyung Koh ◽  
Do-Young Jung
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Knee Extension ◽  
Control Group ◽  
Post Intervention ◽  
Lower Back ◽  
Hamstring Muscles ◽  
Before And After ◽  
The Difference ◽  
Pressure Biofeedback

Background: Stretching and length test of hamstring muscles have been performed commonly to manage lower back pain (LBP) in sports rehabilitation. Previous literatures addressed that stretching techniques and length test of hamstring muscles should be performed with the pelvic maintained in an anterior tilt position. However, there is no study to determine the effectiveness of pressure biofeedback unit (PBU) to maintain in anterior pelvic tilting (APT) on length test and stretching of hamstring muscles. Objective: To determine the effectiveness of hamstring muscles stretching using a PBU. Methods: Forty participants with shortness of hamstrings randomized into two groups. Participants performed the active knee extension (AKE) stretching without (control group) or with PBU (intervention group) for four weeks. AKE tests without and with PBU were administered three times before and after hamstrings stretching by each group. Results: The AKE test without PBU showed a significant main effect of time ([Formula: see text]) but not of group ([Formula: see text]) on the AKE angle. The AKE test with PBU showed a significant increase in the AKE angle in the post-intervention compared to the pre-intervention assessments in both groups ([Formula: see text]). The difference of AKE angle between the pre- and post-intervention results was significantly greater in the intervention group than in the control group ([Formula: see text]). Conclusion: We recommend the use of a PBU to maintain the pelvic anterior tilting position when performing the AKE test or AKE stretching.

scholarly journals Robot-assisted gait training to reduce pusher behavior

Neurology ◽  
2018 ◽  
Vol 91 (14) ◽  
pp. e1319-e1327 ◽  
Author(s):  
Jeannine Bergmann ◽  
Carmen Krewer ◽  
Klaus Jahn ◽  
Friedemann Müller
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Gait Training ◽  
Class Ii ◽  
Control Group ◽  
Robot Assisted ◽  
Post Intervention ◽  
Subacute Stroke ◽  
Post Test

ObjectiveTo determine the effects of 2 weeks of intensive robot-assisted gait training (RAGT) on pusher behavior compared to nonrobotic physiotherapy (nR-PT).MethodsIn a single-blind, randomized, controlled trial with 2 parallel arms, we compared 2 weeks of daily RAGT (intervention group) with the same amount of nR-PT (control group). Patients with subacute stroke who had pusher behavior according to the Scale for Contraversive Pushing (SCP) were included. The primary research questions were whether changes in pusher behavior would differ between groups post intervention, and at a follow-up 2 weeks afterward (SCP and Burke Lateropulsion Scale, Class II evidence). Secondary outcomes included the Performance-Oriented Mobility Assessment, the Functional Ambulation Classification, and the Subjective Visual Vertical.ResultsThirty-eight patients were randomized. Thereof, 30 patients received the allocated intervention and were included in the analyses. RAGT led to a larger reduction of pusher behavior than nR-PT at post test (SCP: U = 69.00, r = −0.33, p = 0.037; Burke Lateropulsion Scale: U = 47.500, r = −0.50, p = 0.003) and at follow-up (SCP: U = 54.00, r = −0.44, p = 0.008). Pusher behavior had ceased in 6 of 15 participants in the intervention group and 1 of 15 participants in the control group at post test. At follow-up, 9 of 15 and 5 of 15 participants, respectively, no longer exhibited the behavior.ConclusionsTwo weeks of RAGT seems to persistently reduce pusher behavior, possibly by recalibrating the disturbed inner reference of verticality. The potential benefits of RAGT on pusher behavior and verticality perception require further investigation.Trial registrationGerman Clinical Trials Register (registration number: DRKS00003444).Classification of evidenceThis study provides Class II evidence that RAGT is beneficial to reduce pusher behavior in patients with stroke.

scholarly journals Effect of Oral Ingestion of Low-Molecular Collagen Peptides Derived from Skate (Raja Kenojei) Skin on Body Fat in Overweight Adults: A Randomized, Double-Blind, Placebo-Controlled Trial

Marine Drugs ◽  
2019 ◽  
Vol 17 (3) ◽  
pp. 157 ◽  
Author(s):  
Young Tak ◽  
Yun Kim ◽  
Jeong Lee ◽  
Yu-Hyun Yi ◽  
Young Cho ◽  
...  
Keyword(s):  
Body Fat ◽  
Animal Studies ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Collagen Peptides ◽  
Collagen Peptide ◽  
Skin Collagen ◽  
Overweight Adults

Recent animal studies found the potential of a collagen peptide derived from skate skin to have anti-obesity effects through the suppression of fat accumulation and regulation of lipid metabolism. However, no studies have yet been performed in humans. Here, this very first human randomized, placebo-controlled, and double-blinded study was designed to investigate the efficacy and tolerability of skate skin collagen peptides (SCP) for the reduction of body fat in overweight adults. Ninety healthy volunteers (17 men) aged 41.2 ± 10.4 years with a mean body mass index of 25.6 ± 1.9 kg/m2 were assigned to the intervention group (IG), which received 2000 mg of SCP per day or to the control group (CG) given the placebo for 12 weeks and 81 (90%) participants completed the study. Changes in body fat were evaluated using dual energy X-ray absorptiometry as a primary efficacy endpoint. After 12 weeks of the trial, the percentage of body fat and body fat mass (kg) in IG were found to be significantly better than those of subjects in CG (−1.2% vs. 2.7%, p = 0.024 and −1.2 kg vs. 0.3 kg, p = 0.025). Application of SCP was well tolerated and no notable adverse effect was reported from both groups. These results suggest the beneficial potential of SCP in the reduction of body fat in overweight adults.

Sign in / Sign up

Export Citation Format

Share Document