The "Metabolically-obese Normal-weight" Phenotype and Its Reversal by Calorie Restriction

NCT03239782 | Completed

• 1 other identifier: MONW
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glucose Metabolism Disorders; Obesity, Visceral; Obesity; Endocrine; Insulin Sensitivity/Resistance

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Metabolically unhealthy

EXPERIMENTAL

Subjects classified as metabolically unhealthy (MONW) go on to participate in a calorie restriction intervention. MONW subjects will participate in a supervised weight loss program to help ensure they are under a similar weekly energy deficit and achieve a 5 % weight loss at approximately the same time. Participants will be prescribed a reduced-calorie diet (\~500 kcal/d below their needs for weight maintenance), and will be instructed not to change their physical activity habits, in order to achieve a weekly weight loss of \~0.5 kg. The macronutrient composition of the diet will be the same for all groups (55-60 % of energy from carbohydrate, 15-20 % from protein, and 20-30 % from fat); no vitamins or other nutritional supplements will be given.

Behavioral: Calorie restriction

Interventions

Calorie restriction BEHAVIORAL

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

Metabolically unhealthy

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female
• Chinese or Indian descent
• Between 21-65 years old (inclusive)
• BMI from \>=19 to \<25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore Institute of Food and Biotechnology Innovation: lead

Related Publications (54)

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MeSH Terms

Conditions

Glucose Metabolism Disorders; Obesity, Abdominal; Obesity; Insulin Resistance

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Faidon Magkos, PhD

  Singapore Institute for Clinical Sciences, Agency for Science, Technology and Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 4, 2017
• Study Start: March 29, 2016
• Primary Completion: October 7, 2017
• Study Completion: October 7, 2017
• Last Updated: March 13, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share