Progressive Weight Loss and Metabolic Health (PWL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01299519
First received: February 10, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The investigators are looking to see if weight loss will result in decreased deposits of fat in the body (total body fat, abdominal fat, liver fat, fat in the muscle) and an improvement of energy production by the muscle. The investigators also are looking to see if weight loss will lead to improved sugar metabolism and cardiovascular health, change in the microorganisms that are present in the intestine, and decreased body temperature. The investigators are looking to see if weight loss will improve the way the brain functions, and also the brain's structure.

The investigators also are looking to see if greater amounts of weight loss will lead to greater improvements for each variable or if the minimum weight loss threshold for achieving a beneficial effect will be different for the different parts of the body.

This will provide important information that will help optimize diets to achieve the most favourable health benefits and potentially provide new insights into obesity related metabolic abnormalities such as diabetes and cardiovascular disease.

If you are enrolled in this study, you will be randomly assigned (by chance, like the flip of a coin) to one of 2 groups. Group 1: supervised weight loss group (low-calorie diet). Group 2: supervised weight maintenance group (normal diet).

After testing at the beginning of the study: Group 1 will lose 5%, 10%, and 15% of their weight over time under the guidance of a dietitian. The investigators expect the complete weight loss to require approximately one year. Research testing will be repeated at each time point. Group 2 will maintain their weight. 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.

  • gut microflora [ Time Frame: baseline through weight loss (approximately one year) ] [ Designated as safety issue: No ]
    In the weight-loss arm we will measure gut microflora 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 gut microflora at baseline and after six months.

  • brain structure [ Time Frame: baseline through weight loss (approximately one year) ] [ Designated as safety issue: No ]
    In the weight-loss arm we will measure brain structure 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 brain structure at baseline and after six months.

  • brain function [ Time Frame: baseline through weight loss (approximately one year) ] [ Designated as safety issue: No ]
    In the weight-loss arm we will measure brain function at baseline and after 10% 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 brain function at baseline and after six months.


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: weight loss
Subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, 5-10% through meal replacement therapy, and 10-15% through a very-low-calorie diet which can include liquid formula. In total subjects in this arm are to lose 15% of their body weight. Each weight loss phase will last an average of four months for a total of approximately one year.
Behavioral: Weight Loss
Subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, 5-10% through meal replacement therapy, and 10-15% through a very-low-calorie diet which can include liquid formula. In total subjects in this arm are to lose 15% of their body weight. Each weight loss phase will last an average of four months for a total of approximately one year.
Active Comparator: weight maintenance
Subjects in the weight maintenance arm are to maintain a steady body weight (plus or minus two percent of initial body weight) for six months.
Behavioral: weight maintenance
Subjects in the weight maintenance arm are to maintain a steady body weight (plus or minus two percent 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 2

Exclusion Criteria:

  • diabetes
  • smoking
  • pregnancy
  • breastfeeding
  • heart failure
  • history of liver disease including hepatitis
  • alcoholism
  • exercise more than one hour 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

Contacts
Contact: Emily Lake, B.A. 314-747-3758 elake@dom.wustl.edu
Contact: Melisa R Moore, BSN 314-362-8604 mmoore@dom.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Emily Jenkerson         
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: June 24, 2014
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
Obesity
Weight Loss
Body Weight
Body Weight Changes
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014