Progressive Weight Loss and Metabolic Health (PWL)

June 30, 2017 updated by: Washington University School of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: 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.
Active Comparator: 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.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Sensitivity
Time Frame: 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.
baseline through weight loss (approximately one year)
intra-hepatic triglyceride
Time Frame: 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.
baseline through weight loss (approximately one year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
total cholesterol
Time Frame: 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.
baseline through weight loss (approximately one year)
systolic blood pressure
Time Frame: 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.
baseline through weight loss (approximately one year)
Cell proliferation (growth) rates in the colon - optional procedure
Time Frame: 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.
baseline through weight loss (approximately four months to one year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 10, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

July 5, 2017

Last Update Submitted That Met QC Criteria

June 30, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201012904

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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