Progressive Weight Loss and Metabolic Health - Full Text View

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 loss Behavioral: weight maintenance

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:

MedlinePlus related topics: Diabetes Medicines Obesity Weight Control

U.S. FDA Resources

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, 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 function at baseline and after six months.

Estimated Enrollment:	40
Study Start Date:	February 2011
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	February 2013 (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, an additional 5% through meal replacement therapy, and finally another 5% weight loss a liquid formula very-low-calorie diet. 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 undergoing the weight loss intervention are to lose 5% of their weight through a low-calorie diet, an additional 5% through meal replacement therapy, and finally another 5% weight loss a liquid formula very-low-calorie diet. 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 pounds) for six months.	Behavioral: weight maintenance Subjects in the weight maintenance arm are to maintain a steady body weight (plus or minus two pounds) for six months.

Arms

Assigned Interventions

Experimental: weight loss

Subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, an additional 5% through meal replacement therapy, and finally another 5% weight loss a liquid formula very-low-calorie diet. 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 undergoing the weight loss intervention are to lose 5% of their weight through a low-calorie diet, an additional 5% through meal replacement therapy, and finally another 5% weight loss a liquid formula very-low-calorie diet. 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 pounds) for six months.

Behavioral: weight maintenance

Subjects in the weight maintenance arm are to maintain a steady body weight (plus or minus two pounds) 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 3

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

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

Contacts

Contact: Emily Jenkerson, B.A.

314-362-1000

jenkersone@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:

de Jonge L, Moreira EA, Martin CK, Ravussin E; Pennington CALERIE Team. Impact of 6-month caloric restriction on autonomic nervous system activity in healthy, overweight, individuals. Obesity (Silver Spring). 2010 Feb;18(2):414-6. Epub 2009 Nov 12.

Volkow ND, Wang GJ, Telang F, Fowler JS, Goldstein RZ, Alia-Klein N, Logan J, Wong C, Thanos PK, Ma Y, Pradhan K. Inverse association between BMI and prefrontal metabolic activity in healthy adults. Obesity (Silver Spring). 2009 Jan;17(1):60-5. Epub 2008 Oct 23.

McLaughlin T, Abbasi F, Kim HS, Lamendola C, Schaaf P, Reaven G. Relationship between insulin resistance, weight loss, and coronary heart disease risk in healthy, obese women. Metabolism. 2001 Jul;50(7):795-800.

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 24, 2011
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
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013

Progressive Weight Loss and Metabolic Health (PWL)