Progressive Weight Loss and Metabolic Health (PWL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01299519
First received: February 10, 2011
Last updated: August 28, 2015
Last verified: August 2015
  Purpose

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 Intervention
Insulin Resistance
Obesity
Behavioral: Weight Maintenance
Behavioral: Weight Loss

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Progressive Weight Loss and Metabolic Health

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: baseline through weight loss (approximately one year) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline through weight loss (approximately one year) ] [ Designated as safety issue: No ]
    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:
  • total cholesterol [ Time Frame: baseline through weight loss (approximately one year) ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline through weight loss (approximately one year) ] [ Designated as safety issue: No ]
    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.


Enrollment: 59
Study Start Date: February 2011
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299519

Locations
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Samuel Klein, MD Washington University School of Medicine
  More Information

Publications:
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01299519     History of Changes
Other Study ID Numbers: 201012904
Study First Received: February 10, 2011
Last Updated: August 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
obesity
weight loss
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Weight Loss
Body Weight
Body Weight Changes
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 01, 2015