MRI Derived Organ & Tissue Mass Changes With Weight Loss - Ancillary to Look AHEAD
Primary Purpose
Cardiovascular Diseases, Atherosclerosis, Obesity
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
An estimated 140 obese, diabetic men and women, ages 45 or older. There will be 70 women (50%) and 20% minorities
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00031200
First Posted
February 27, 2002
Last Updated
July 28, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00031200
Brief Title
MRI Derived Organ & Tissue Mass Changes With Weight Loss - Ancillary to Look AHEAD
Study Type
Observational
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
February 2007 (Actual)
Study Completion Date
February 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To investigate the composition and nature of weight loss and weight maintenance during the Look AHEAD trial. Also, to model changes in resting energy expenditure and changes in cardiac structure and function associated with weight loss.
Detailed Description
BACKGROUND:
Advances in science are often achieved with the development of technology that allows scientists to differentiate and refine concepts which were previously undifferentiated. The field of obesity research has progressed from simple measurement of weight loss to multi-compartment models of fat, fat-free mass and regional distribution of fat. An opportunity for further refinement now presents itself in that magnetic resonance imaging technology can be used to image individual organs and tissues. This presents the opportunity to investigate important unresolved questions. For example, information is lacking on the effects of weight loss on individual organs and tissues. The loss of fat free mass (FFM) cannot fully explain the reported decrease in resting energy expenditure (REE) that accompanies weight loss. Since the FFM compartment consists of numerous tissues and organs, each with a different oxidative metabolic capacity, the possibility exists that individual vital organs may change disproportionately to the change in total FFM with weight loss, thereby explaining reductions in REE post weight loss. Complete organ-tissue volume and mass reconstruction of most major compartments is now possible, using magnetic resonance imaging (MRI).
The study is ancillary to the Look AHEAD clinical trial which is sponsored primarily by the National Institute of Diabetes and Digestive and Kidney Diseases and secondarily by the National Heart, Lung, and Blood Institute, the National Institute of Nursing Research, the Office of Research on Women's Health, the National Center on Minority Health and Health Disparities, and the Centers for Disease Control and Prevention. The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss in overweight diabetics.
DESIGN NARRATIVE:
The study will describe the composition of weight loss in diabetic subjects at the tissue/organ level of body composition; specifically, to determine whether and to what degree different tissues and organs are conserved or lost in comparison to total fat free mass (FFM) change during weight loss. The study will also assess the effects of aging on organ and tissue mass in 50+ year old diabetic men and women in a control group. The study will test whether a portion of weight loss related changes in resting energy expenditure (REE) can be explained by changes in the relative fractions of body mass as high (brain, heart, liver, kidney) and low (skeletal muscle, adipose tissue) metabolic activity tissues with respect to oxidative metabolism in 50 plus year old diabetic men and women. A secondary aim is to assess the effects of weight loss on cardiac structure and function using cardiac gated MRI. Consenting, eligible Look AHEAD participants at St. Luke's and at the University of Pittsburgh will participate in MRI and REE tests. Seventy men and women will be measured, equally distributed between the two sites, and equally distributed between Lifestyle Intervention group and a Community Care group. Measures will be acquired at baseline, following one year of intervention (Year 1), and following one year of maintenance (Year 2), to produce a 2 X 3 factorial design.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Atherosclerosis, Obesity, Diabetes Mellitus, Non-insulin Dependent, Heart Diseases, Myocardial Infarction, Diabetes Mellitus
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
An estimated 140 obese, diabetic men and women, ages 45 or older. There will be 70 women (50%) and 20% minorities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dympna Gallagher
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
12. IPD Sharing Statement
Citations:
PubMed Identifier
14567146
Citation
Gallagher D, Song MY. Evaluation of body composition: practical guidelines. Prim Care. 2003 Jun;30(2):249-65. doi: 10.1016/s0095-4543(03)00030-7.
Results Reference
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PubMed Identifier
15090643
Citation
He Q, Horlick M, Thornton J, Wang J, Pierson RN Jr, Heshka S, Gallagher D. Sex-specific fat distribution is not linear across pubertal groups in a multiethnic study. Obes Res. 2004 Apr;12(4):725-33. doi: 10.1038/oby.2004.85.
Results Reference
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MRI Derived Organ & Tissue Mass Changes With Weight Loss - Ancillary to Look AHEAD
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