Heavy Metals, Obesity and Cardiovascular Risk - Ancillary to Look AHEAD

July 28, 2016 updated by: National Heart, Lung, and Blood Institute (NHLBI)
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.

Study Overview

Status

Completed

Conditions

Detailed Description

BACKGROUND:

Heavy metals are a heterogeneous group of highly reactive substances, which may act as essential cofactors for physiologic processes and/or 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 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:

This is an ancillary prospective observational study within the Look AHEAD trial. The ancillary study will collect toenail clippings from all participants (n = 5,000) 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 Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

An estimated 5,000 obese diabetic subjects from the Look AHEAD clinical trial. There will be 2,500 women (50%) and 30% minorities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Eliseo Guallar, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

August 1, 2007

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

February 27, 2002

First Submitted That Met QC Criteria

February 27, 2002

First Posted (Estimate)

February 28, 2002

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 992
  • R01HL070299 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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