Diet, Insulin Resistance, and Cardiovascular Risk

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005530
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: August 2004

May 25, 2000
June 23, 2005
May 1994
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Complete list of historical versions of study NCT00005530 on ClinicalTrials.gov Archive Site
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Diet, Insulin Resistance, and Cardiovascular Risk
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To elucidate dietary factors that elevate risk for cardiovascular disease (CVD) in conjunction with insulin resistance.

BACKGROUND:

Clinical studies indicate that high carbohydrate intake may exacerbate the dyslipidemia often seen with insulin resistance. Consequently, there is much debate as to the optimal dietary pattern for individuals with NIDDM to minimize risk for microvascular disease. Data on this topic from free-living populations are scarce. In addition, associations of dietary antioxidants with CVD risk have not been evaluated in large community samples of persons with diabetes.

DESIGN NARRATIVE:

Potential dietary determinants of hyperinsulinemia or of insulin resistance were evaluated, including high intake of dietary fats and of simple sugars and low alcohol consumption. As a major focus, dietary factors that may contribute to elevated CVD risk among persons with existing insulin resistance, including impaired glucose tolerance (IGT) and non-insulin-dependent diabetes mellitus (NIDDM) were examined. Five datasets from epidemiologic studies were available to evaluate specific hypotheses for men and women of Black, Hispanic and non-Hispanic white ethnicity. The unique contributions of each dataset were as follows. The San Luis Valley Diabetes Study and the San Antonio Heart Study enabled prospective analyses for large numbers of subjects with IGT or NIDDM; the Mexico City Study provided a sample with contrasting dietary patterns in a non-white population; the Kaiser Permanente Women Twins Study allowed for the removal of genetic influences by evaluating associations within monozygotic twin pairs; and the Insulin Resistance Atherosclerosis Study (IRAS) provided direct measurement of insulin sensitivity and subclinical atherosclerosis across the spectrum of glucose tolerance in three ethnic groups.

An understanding of the accuracy of the dietary assessment instruments used in the three ethnic groups was critical to the interpretation of the findings related to diet and CVD risk variables. Therefore, a second component of research was also conducted, that being an evaluation of the comparative validity of the food frequency interview used in the multi- cultural IRAS population using a series of 24-hour dietary recalls as the standard.

Observational
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  • Cardiovascular Diseases
  • Heart Diseases
  • Insulin Resistance
  • Hyperinsulinism
  • Diabetes Mellitus, Non-insulin Dependent
  • Diabetes Mellitus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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April 2000
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005530
5063
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National Heart, Lung, and Blood Institute (NHLBI)
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Investigator: Elizabeth Mayer-Davis University of South Carolina
National Heart, Lung, and Blood Institute (NHLBI)
August 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP