Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031213
Status:
COMPLETED
Last Update Posted:
2016-07-29
First Post:
2002-02-27
Brief Title:
Heavy Metals Obesity and Cardiovascular Risk - 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 evaluate the relationship of baseline toenail chromium concentrations to weight loss as well as the interaction between heavy metals and the beneficial effects of weight loss
Detailed Description:
BACKGROUND
Heavy metals are a heterogeneous group of highly reactive substances which may act as essential cofactors for physiologic processes andor as toxic elements Chromium in particular has been associated with obesity diabetes and weight loss Other heavy metals have been associated with some of the consequences of obesity including hypertension hyperlipidemia and cardiovascular disease The Look AHEAD Study a large randomized controlled trial of intensive lifestyle intervention for weight loss in obese patients with Type 2 diabetes mellitus provides an excellent opportunity to address the impact of chromium on weight loss and diabetes control as well as to assess the impact of other heavy metals on the physiologic consequences of weight loss
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
This is an ancillary prospective observational study within the Look AHEAD trial The ancillary study will collect toenail clippings from all participants n 5000 at baseline and at the 1-year visit and analyze a random subset of the toenails for their heavy metal content using instrumental neutron activation analysis Toenails provide a time-integrated measure of heavy metal exposure while instrumental neutron activation analysis provides the concentrations of about 50 heavy metals in the toenail samples including chromium This information will allow an evaluation of the relationship of baseline toenail chromium concentrations to weight loss as well as the interaction between heavy metals and the beneficial effects of weight loss The proposed study may provide valuable insight into the determinants of the efficacy of weight loss interventions In fact the Look AHEAD trial because of its size may be one of the few studies in which these relationships can be measured reliably In addition the ancillary study will permit the setup of a specimen bank of toenails to be used in future case-cohort or nested case-control studies of the association of heavy metals with Look AHEAD endpoints especially myocardial infarction and cardiovascular death
Heavy metals are a heterogeneous group of highly reactive substances which may act as essential cofactors for physiologic processes andor as toxic elements Chromium in particular has been associated with obesity diabetes and weight loss Other heavy metals have been associated with some of the consequences of obesity including hypertension hyperlipidemia and cardiovascular disease The Look AHEAD Study a large randomized controlled trial of intensive lifestyle intervention for weight loss in obese patients with Type 2 diabetes mellitus provides an excellent opportunity to address the impact of chromium on weight loss and diabetes control as well as to assess the impact of other heavy metals on the physiologic consequences of weight loss
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
This is an ancillary prospective observational study within the Look AHEAD trial The ancillary study will collect toenail clippings from all participants n 5000 at baseline and at the 1-year visit and analyze a random subset of the toenails for their heavy metal content using instrumental neutron activation analysis Toenails provide a time-integrated measure of heavy metal exposure while instrumental neutron activation analysis provides the concentrations of about 50 heavy metals in the toenail samples including chromium This information will allow an evaluation of the relationship of baseline toenail chromium concentrations to weight loss as well as the interaction between heavy metals and the beneficial effects of weight loss The proposed study may provide valuable insight into the determinants of the efficacy of weight loss interventions In fact the Look AHEAD trial because of its size may be one of the few studies in which these relationships can be measured reliably In addition the ancillary study will permit the setup of a specimen bank of toenails to be used in future case-cohort or nested case-control studies of the association of heavy metals with Look AHEAD endpoints especially myocardial infarction and cardiovascular death
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 |
|---|---|---|---|
| R01HL070299 | NIH | None | httpsreporternihgovquickSearchR01HL070299 |