Clinical Trials Logo

Clinical Trial Summary

Obesity, with a prevalence of over 35% in American adults, is considered the most critical threat to the health and well-being of Americans. Obesity-associated metabolic abnormalities, including hyperglycemia, insulin resistance, and dyslipidemia, contribute substantially to elevated risk of cardiovascular disease (CVD) and diabetes. Although significant and sustained lifestyle modifications in diet and exercise are effective in reducing weight and improving obesity-related metabolic disturbances, long-term compliance to drastic changes in diet and daily activity patterns is often difficult to attain given the hectic lifestyle of modern societies. Health-promoting nutraceuticals - naturally occurring bioactive compounds capable of eliciting targeted molecular responses at the cellular level - may be an effective and convenient strategy to assist in weight reduction and reduce disease risk factors in obese individuals. Furthermore, nutraceutical compounds could prove to be a powerful adjunct to lifestyle and pharmacological weight reduction therapies, as they are relatively safe, cost effective, and possess the ability to modulate specific, and sometimes multiple, molecular targets. As a dietary supplement, alpha-lipoic acid appears to have broad molecular specificity with an impressive array of metabolic health benefits that include weight loss, reduction in blood lipids, and improved glycemic control. As the effects of alpha-lipoic acid supplementation for dyslipidemia, hyperglycemia, and body composition through appetite suppression and increased energy expenditure have been repeatedly confirmed in multiple animal models, it is surprising that there has been limited effort to translate these responses to human subjects. Given the strong pre-clinical data supporting the health benefits of alpha-lipoic acid, there is a clear need to conduct controlled interventions to address the current clinical knowledge gap and assess if the anti-diabetic effect of α-lipoic acid can be translated to humans. The primary objective of this application is to determine the efficacy of alpha-lipoic acid supplementation on glycemic control and body composition in obese pre-diabetic adults. The investigators hypothesize that alpha-lipoic acid supplementation will improve biomarkers of diabetes and cardiovascular risk and promote changes in body composition in obese adults.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03612037
Study type Interventional
Source State University of New York at Buffalo
Contact
Status Completed
Phase N/A
Start date September 1, 2016
Completion date December 30, 2018

See also
  Status Clinical Trial Phase
Recruiting NCT05354245 - Using a Complex Carbohydrate Mixture to Steer Fermentation and Improve Metabolism in Adults With Overweight and Prediabetes (DISTAL) N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT06115265 - Ketogenic Diet and Diabetes Demonstration Project N/A
Completed NCT03188263 - Morning Light Treatment to Improve Glucose Metabolism N/A
Recruiting NCT03821961 - 18F-FDOPA PET/CT Imaging in Patients Undergoing Metabolic Surgery N/A
Completed NCT04303468 - Intervention With a GABA Supplement in Prediabetics N/A
Recruiting NCT06094231 - Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study N/A
Completed NCT03675360 - Low-Carbohydrate Dietary Pattern on Glycemic Outcomes Trial N/A
Completed NCT01910051 - Explorative Assessment of Biomarkers in Overweight and Obese Subjects
Completed NCT03527368 - The Time-Restricted Intake of Meals Study N/A
Not yet recruiting NCT06453278 - (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
Completed NCT02899390 - Diabetes Prevention Program in Adults of the Yaqui Tribe of Hermosillo, Sonora at Risk of Diabetes N/A
Suspended NCT03240978 - Exercise Intervention for the Prevention of Prediabetes in Overweight Chinese N/A
Completed NCT03865342 - Prevention of Diabetes Using Mobile-enabled, Virtual Delivery of the National Diabetes Prevention Program N/A
Recruiting NCT01972113 - Vitamin K and Glucose Metabolism in Children at Risk for Diabetes (Vita-K 'n' Kids Study) N/A
Completed NCT01436916 - Oral Cholecalciferol in Prevention of Type 2 Diabetes Mellitus Phase 4
Completed NCT01432509 - Prospective Follow-up of a Cohort of Pre-diabetics in the North of France (DiabeNord) N/A
Completed NCT00990184 - Study to Evaluate the Effects of Colesevelam on Insulin Sensitivity and ß-Cell Function in Subjects With Impaired Fasting Glucose (Prediabetes) Phase 3
Completed NCT00886340 - A Lifestyle Change Program to Prevent Type 2 Diabetes Phase 2