Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031226
Status:
COMPLETED
Last Update Posted:
2014-03-13
First Post:
2002-02-27
Brief Title:
Biomarkers of Oxidative Stress in LOOK AHEAD - Ancillary to LOOK AHEAD
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-03
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 determine how weight loss achieved by intensive lifestyle intervention including diet and exercise alters lipoprotein oxidationoxidative stress and antioxidant status in overweight diabetic individuals
Detailed Description:
BACKGROUND
Overweight and diabetes increase risk of cardiovascular disease but the mechanisms that account for this effect remain to be clarified Oxidation of low-density lipoprotein LDL is thought to contribute to atherosclerosis Diabetes may increase oxidative stress and this may contribute to increased risk of cardiovascular disease in diabetics Caloric restriction and the initiation of exercise may increase oxidative stress in the short term and may thus adversely affect cardiovascular disease Over the long term metabolic adaptation may reduce oxidative stress Such adaptation together with beneficial changes in lipoprotein concentration composition and character may allow expression of beneficial effects of weight loss on cardiovascular endpoints However the influence of weight loss on measures of lipoprotein oxidationoxidative stress and antioxidant status in overweight diabetics has never been investigated
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 The study is in response to an initiative on Ancillary Studies in Heart Lung and Blood Disease Trials released in June 2000
DESIGN NARRATIVE
The primary aim of this project is to determine the influence of intensive lifestyle intervention on lipoprotein oxidation as assessed by autoantibodies to oxidized low-density lipoprotein Other complementary indices of oxidative stress and antioxidant status as assessed by circulating concentrations of lipophilic antioxidants will be compared between lifestyle intervention and community care control arms of the Look AHEAD study Such comparisons will be performed both early after intervention and later when metabolic adaptation is expected By contrasting subgroups defined by differential compliance to diet or exercise by gender menopausal status ethnicity and age secondary aims will consider whether changes in lipoprotein oxidationoxidative stress and antioxidant status differ between such subgroups Other aims will consider whether differences in lipoprotein oxidationoxidative stress among the above subgroups can be accounted for by differences in lipoprotein concentration composition or character carbohydrate metabolism or antioxidant status The results of this study will provide a potential mechanistic explanation for differences in cardiovascular endpoints between intervention and community care groups
Overweight and diabetes increase risk of cardiovascular disease but the mechanisms that account for this effect remain to be clarified Oxidation of low-density lipoprotein LDL is thought to contribute to atherosclerosis Diabetes may increase oxidative stress and this may contribute to increased risk of cardiovascular disease in diabetics Caloric restriction and the initiation of exercise may increase oxidative stress in the short term and may thus adversely affect cardiovascular disease Over the long term metabolic adaptation may reduce oxidative stress Such adaptation together with beneficial changes in lipoprotein concentration composition and character may allow expression of beneficial effects of weight loss on cardiovascular endpoints However the influence of weight loss on measures of lipoprotein oxidationoxidative stress and antioxidant status in overweight diabetics has never been investigated
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 The study is in response to an initiative on Ancillary Studies in Heart Lung and Blood Disease Trials released in June 2000
DESIGN NARRATIVE
The primary aim of this project is to determine the influence of intensive lifestyle intervention on lipoprotein oxidation as assessed by autoantibodies to oxidized low-density lipoprotein Other complementary indices of oxidative stress and antioxidant status as assessed by circulating concentrations of lipophilic antioxidants will be compared between lifestyle intervention and community care control arms of the Look AHEAD study Such comparisons will be performed both early after intervention and later when metabolic adaptation is expected By contrasting subgroups defined by differential compliance to diet or exercise by gender menopausal status ethnicity and age secondary aims will consider whether changes in lipoprotein oxidationoxidative stress and antioxidant status differ between such subgroups Other aims will consider whether differences in lipoprotein oxidationoxidative stress among the above subgroups can be accounted for by differences in lipoprotein concentration composition or character carbohydrate metabolism or antioxidant status The results of this study will provide a potential mechanistic explanation for differences in cardiovascular endpoints between intervention and community care groups
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 |
|---|---|---|---|
| R01HL070300 | NIH | None | httpsreporternihgovquickSearchR01HL070300 |