Glucose Metabolism Disorders Clinical Trial
Official title:
The "Metabolically-obese Normal-weight" Phenotype in Two Asian Ethnic Groups and Its Reversal by Calorie Restriction
Verified date | March 2018 |
Source | Clinical Nutrition Research Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 77 |
Est. completion date | October 7, 2017 |
Est. primary completion date | October 7, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Healthy male or female - Chinese or Indian descent - Between 21-65 years old (inclusive) - BMI from >=19 to <25 kg/m2 Exclusion Criteria: - BMI =25 kg/m2 - BMI <19 kg/m2 (to avoid the risk of subjects becoming seriously underweight (i.e. BMI =18 kg/m2) after 5 % weight loss) - Age <21 and >65 yrs - Use of medications that can affect metabolic function (including oral contraceptives and hormone replacement therapy) - Regular use of tobacco products - Regular consumption of alcohol - Pregnant or breastfeeding women - Evidence of significant organ system dysfunction or disease - Recent weight loss (=5 % over the past 6 months) - Severe asthma and respiratory problems that prevent subjects from exercising |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Clinical Nutrition Research Centre, Singapore |
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* Note: There are 52 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Whole-body insulin sensitivity | Our primary endpoint is whole-body insulin sensitivity (i.e. the major metabolic correlate of the MONW phenotype), determined by using the hyperinsulinemic-euglycemic clamp. | 3 hours |
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