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Progressive Weight Loss and Metabolic Health (PWL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01299519
Recruitment Status : Completed
First Posted : February 18, 2011
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Obesity Behavioral: Weight Maintenance Behavioral: Weight Loss Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Progressive Weight Loss and Metabolic Health
Study Start Date : February 2011
Actual Primary Completion Date : September 2015
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01299519


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Samuel Klein, MD Washington University School of Medicine
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01299519    
Other Study ID Numbers: 201012904
First Posted: February 18, 2011    Key Record Dates
Last Update Posted: July 5, 2017
Last Verified: June 2017
Keywords provided by Washington University School of Medicine:
obesity
weight loss
insulin resistance
Additional relevant MeSH terms:
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Insulin Resistance
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases