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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
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 27, 2002
    Last Updated
    July 28, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    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
    background
    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
    background

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