CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 77 enrolled
Drug / intervention
Calorie restrictionbehavioral
Likely dose
Not stated in record
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Search/NCT03239782
NCT03239782N/ACompleted

The "Metabolically-obese Normal-weight" Phenotype in Two Asian Ethnic Groups and Its Reversal by Calorie Restriction

Singapore Institute of Food and Biotechnology Innovation·interventional·Posted Aug 4, 2017·Updated Mar 13, 2018

In Brief

A clinical study evaluating Calorie restriction for Glucose Metabolism Disorders and 3 related conditions. Completed, enrolled 77 participants.

Detailed Summary

The prevalence of overweight and obesity in Singapore is approximately half of that in the United States, yet the incidence of type 2 diabetes is similar, and is expected to double in the near future. This indicates that metabolic dysfunction, particularly insulin resistance, is widely prevalent even among individuals who are considered normal-weight or lean by conventional measures, i.e. body mass index (BMI) and percent body fat. These individuals are often referred to as "metabolically-obese normal-weight" (MONW), and have increased risk for cardiometabolic disease despite their normal BMI and total body fat values. The prevalence of the MONW phenotype varies across populations and differs markedly among different ethnicities. However, our understanding of the complex interactions between ethnicity, body composition, and metabolic dysfunction and its reversal remains rudimentary. Previous attempts to characterize the MONW phenotype are confounded by the small but significant differences in BMI or percent body fat between groups (even if all subjects were lean, within the "normal" range), with MONW subjects being always "fatter" than the corresponding control subjects. There are no published studies that prospectively recruited groups of metabolically healthy and unhealthy lean individuals matched on BMI and percent body fat. Furthermore, although weight loss improves body composition and many of the cardiometabolic abnormalities in most obese patients, little is known about the possible therapeutic effects of calorie restriction in MONW subjects. Accordingly, a better understanding of the MONW phenotype and the evaluation of therapeutic approaches for its reversal will have important implications for public health. By facilitating earlier identification of these subjects, who are more likely to go undiagnosed and thus less likely to be treated before clinically overt cardiometabolic disease develops, results from this study will allow for earlier and effective intervention.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartMar 29, 2016
Primary CompletionOct 7, 2017
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.9 years ago

Interventions

Calorie restrictionbehavioral

Calorie restriction with behavioral modification and provision of one catered, reduced calorie meal a day