Progressive Weight Loss and Metabolic Health

Not Applicable

Completed

• Conditions: Insulin Resistance; Obesity
• Interventions: Behavioral: Weight Loss; Behavioral: Weight Maintenance

• Registration Number: NCT01299519
• Lead Sponsor: Washington University School of Medicine

Brief Summary

This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%) weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes. Participants will be randomly assigned to one of 2 groups. Group 1: supervised weight loss group (low-calorie diet). Group 2: supervised weight maintenance group (normal diet). Of those assigned to group 1, half of the participants will lose 5% of their body weight and the other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a dietitian. Research testing will be repeated at each time point (5%, 10%, and 15% weight loss). In group 2, research testing will be repeated after six months.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-17
• Study First Posted: 2011-02-18
• Primary Completion: 2015-09
• Study Completion: 2016-04
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-30
• Last Update Posted: 2017-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• Obese: Body Mass Index from 30 to 45
• Insulin Resistant: HOMA-IR score greater than or equal to 2

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Exclusion Criteria

• diabetes
• smoking
• pregnancy
• breastfeeding
• heart failure
• history of liver disease including hepatitis
• alcoholism
• exercise more than 2 hours per week

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight Loss	Weight Loss	Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.
Weight Maintenance	Weight Maintenance	Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity	baseline through weight loss (approximately one year)	In the weight-loss arm we will measure insulin sensitivity at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss. Each weight loss phase will last an average of four months for a total of approximately one year. In the weight maintenance arm we will measure insulin sensitivity at baseline and after six months.
intra-hepatic triglyceride	baseline through weight loss (approximately one year)	In the weight-loss arm we will measure intra-hepatic triglyceride at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss. Each weight loss phase will last an average of four months for a total of approximately one year. In the weight maintenance arm we will measure intra-hepatic triglyceride at baseline and after six months.

Secondary Outcome Measures

Name	Time	Method
total cholesterol	baseline through weight loss (approximately one year)	In the weight-loss arm we will measure total cholesterol at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss. Each weight loss phase will last an average of four months for a total of approximately one year. In the weight maintenance arm we will measure total cholesterol at baseline and after six months.
systolic blood pressure	baseline through weight loss (approximately one year)	In the weight-loss arm we will measure systolic blood pressure at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss. Each weight loss phase will last an average of four months for a total of approximately one year. In the weight maintenance arm we will measure systolic blood pressure at baseline and after six months.
Cell proliferation (growth) rates in the colon - optional procedure	baseline through weight loss (approximately four months to one year)	Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples. In the weight-loss arm we will measure colonocyte proliferation rate at baseline, and once again after weight loss (either 5% weight loss, or 10% weight loss, or 15% weight loss; i.e. only one time after weight loss). Each weight loss phase will last an average of four months for a total of approximately one year. In the weight maintenance arm we will measure colonocyte proliferation rate at baseline and after six months.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States