NCT01299519

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 5, 2017

Status Verified

June 1, 2017

Enrollment Period

4.6 years

First QC Date

February 10, 2011

Last Update Submit

June 30, 2017

Conditions

Insulin ResistanceObesity

Keywords

obesityweight lossinsulin resistance

Outcome Measures

Primary Outcomes (2)

  • Insulin Sensitivity

    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

    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 Outcomes (3)

  • total cholesterol

    baseline through weight loss (approximately one year)

  • systolic blood pressure

    baseline through weight loss (approximately one year)

  • Cell proliferation (growth) rates in the colon - optional procedure

    baseline through weight loss (approximately four months to one year)

Study Arms (2)

Weight Loss

EXPERIMENTAL

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

Weight Maintenance

ACTIVE COMPARATOR

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

Interventions

Weight MaintenanceBEHAVIORAL

Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.

Weight Maintenance
Weight LossBEHAVIORAL

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.

Weight Loss

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

  • 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. doi: 10.1038/oby.2009.408. Epub 2009 Nov 12.

    PMID: 19910943BACKGROUND

  • 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. doi: 10.1038/oby.2008.469. Epub 2008 Oct 23.

    PMID: 18948965BACKGROUND

  • 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. doi: 10.1053/meta.2001.24210.

    PMID: 11436184BACKGROUND

  • van Vliet S, Koh HE, Patterson BW, Yoshino M, LaForest R, Gropler RJ, Klein S, Mittendorfer B. Obesity Is Associated With Increased Basal and Postprandial beta-Cell Insulin Secretion Even in the Absence of Insulin Resistance. Diabetes. 2020 Oct;69(10):2112-2119. doi: 10.2337/db20-0377. Epub 2020 Jul 10.

    PMID: 32651241DERIVED

  • Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.

    PMID: 31004409DERIVED

  • Chondronikola M, Magkos F, Yoshino J, Okunade AL, Patterson BW, Muehlbauer MJ, Newgard CB, Klein S. Effect of Progressive Weight Loss on Lactate Metabolism: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Apr;26(4):683-688. doi: 10.1002/oby.22129. Epub 2018 Feb 24.

    PMID: 29476613DERIVED

MeSH Terms

Conditions

Insulin ResistanceObesityWeight Loss

Interventions

Body Weight Maintenance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Intervention Hierarchy (Ancestors)

Body WeightBody SizeGrowthGrowth and DevelopmentPhysiological Phenomena

Study Officials

  • Samuel Klein, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

September 1, 2015

Study Completion

April 1, 2016

Last Updated

July 5, 2017

Record last verified: 2017-06

Locations

US(1)