Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031200
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2002-02-27
Brief Title:
MRI Derived Organ Tissue Mass Changes With Weight Loss - Ancillary to Look AHEAD
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Womens 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 tissueorgan 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 Lukes 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
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 Womens 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 tissueorgan 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 Lukes 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL070298 | NIH | None | httpsreporternihgovquickSearchR01HL070298 |