Study to Investigate Benefits of Weight Loss in Young Adults and Adolescents

Not Applicable

Completed

• Conditions: Obesity; Insulin Resistance
• Interventions: Behavioral: Caloric restrictive diet

• Registration Number: NCT01901978
• Lead Sponsor: Yale University

Brief Summary

The purpose of this study is to investigate the changes in subcutaneous adipocyte size, number and gene expression after weight loss and to assess whether those changes contribute to decreases in ectopic fat accumulation and insulin resistance in women between ages of 16-32.

Detailed Description

There are no studies in young women that have prospectively studied changes in fat cell size, gene expression and insulin sensitivity during the transition from overweight/obese to normal weight. Our preliminary data suggest that the presence of ectopic fat accumulation and insulin resistance in obese children could be considered an "early phase" in the development of T2DM. We hypothesize that a 10% weight loss will restore/improve insulin sensitivity. Furthermore, we speculate that the decrease in subcutaneous fat mass after weight loss is due to a decrease in mean adipocyte cell size, but not cell number.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-15
• Study First Posted: 2013-07-17
• Primary Completion: 2014-07
• Study Completion: 2018-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-28
• Last Update Posted: 2020-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 14

Inclusion Criteria

• Women ages 16-32

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Exclusion Criteria

• They will not be on any medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil. Patients on diuretics will be excluded.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weight Loss	Caloric restrictive diet	Caloric restrictive diet

Primary Outcome Measures

Name	Time	Method
Abdominal fat re-distribution with weight loss	12 weeks	To assess in young women, the effects of weight loss on abdominal fat distribution.

Secondary Outcome Measures

Name	Time	Method
Adipocyte cell size distrubtion and gene expression	12 week	With 10% weight loss, assess changes in cell size distribution and gene expression of adipocytes from the subcutaneous adipose depot.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States