Diet, Insulin Resistance, and Cardiovascular Risk

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005530
• Other study ID #: 5063
• Secondary ID: R29HL053798
• Status: Completed
• Phase: N/A
• First received: May 25, 2000
• Last updated: May 10, 2016
• Start date: May 1994
• Est. completion date: April 2000

Study information

• Verified date: May 2016
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To elucidate dietary factors that elevate risk for cardiovascular disease (CVD) in conjunction with insulin resistance.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 100 Years
• Eligibility: No eligibility criteria

Study Design

N/A

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Non-insulin Dependent
• Diabetes Mellitus, Type 2
• Heart Diseases
• Hyperinsulinism
• Insulin Resistance

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (4)

Bell RA, Mayer-Davis EJ, Martin MA, D'Agostino RB Jr, Haffner SM. Associations between alcohol consumption and insulin sensitivity and cardiovascular disease risk factors: the Insulin Resistance and Atherosclerosis Study. Diabetes Care. 2000 Nov;23(11):1630-6. — View Citation

Mayer EJ, Newman B, Austin MA, Zhang D, Quesenberry CP Jr, Edwards K, Selby JV. Genetic and environmental influences on insulin levels and the insulin resistance syndrome: an analysis of women twins. Am J Epidemiol. 1996 Feb 15;143(4):323-32. — View Citation

Mayer-Davis EJ, Levin S, Marshall JA. Heterogeneity in associations between macronutrient intake and lipoprotein profile in individuals with type 2 diabetes. Diabetes Care. 1999 Oct;22(10):1632-9. — View Citation

Mayer-Davis EJ, Monaco JH, Marshall JA, Rushing J, Juhaeri. Vitamin C intake and cardiovascular disease risk factors in persons with non-insulin-dependent diabetes mellitus. From the Insulin Resistance Atherosclerosis Study and the San Luis Valley Diabetes Study. Prev Med. 1997 May-Jun;26(3):277-83. — View Citation