Influence of Insulin on BP Change During Adolescence

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00007098
First received: December 7, 2000
Last updated: July 23, 2008
Last verified: July 2008
  Purpose

To define the relation of insulin resistance during childhood and adolescence to the development of the insulin resistance syndrome in young adulthood.


Condition
Cardiovascular Diseases
Hypertension
Obesity
Insulin Resistance
Diabetes Mellitus

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: May 1995
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Detailed Description:

BACKGROUND:

The insulin resistance syndrome (IRS) is associated with a considerable increase in the risk of cardiovascular disease in adults. The disorder most likely is inherited to some degree with onset in childhood and early adolescence. The IRS is best defined by quantitative data from euglycemic insulin clamp studies. The investigators have developed a unique data base in children, and by continuing repeated studies and follow-up in early adulthood together with studies in parents and siblings this study should provide important insight into the occurrence and progression of cardiovascular disease in later life.

DESIGN NARRATIVE:

The study is designed to: 1) define the relation of insulin resistance during childhood and adolescence to the development of insulin resistance syndrome (hypertension, dyslipidemia, obesity, and insulin resistance) in young adulthood; and 2) define the relation of insulin resistance within families. The original cohort consists of 357 children who have had two euglycemic insulin clamp studies (at mean ages 13 and 15 years). The specific aims are: to (1) repeat anthropometric and blood pressure measurements at mean ages 18, 19, and 20 and obtain insulin clamps, lipid levels, echocardiograms, and DEXA at mean age 21 in the children; and (2) obtain the measurements, blood and DNA samples, echocardiogram, and insulin clamp in the parents and siblings of the children. Statistical genetics methods are used to estimate heritability and genetic correlations among the insulin resistance syndrome traits. These data address the hypotheses that 1) insulin resistance in childhood predicts insulin resistance and cardiovascular risk factors in young adulthood; 2) insulin resistance in parents is associated with insulin resistance and cardiovascular risk factors in their children; 3) in fat children, BMI and insulin resistance at mean age 13 predicts cardiovascular risk, but in thin children only insulin resistance is a similar predictor; 4) insulin resistance has significant heritability; and 5) there are significant genetic correlations between insulin resistance and the insulin resistance traits. At least 300 of the original cohort of 357 who have had two euglycemic insulin clamps continue on in the study. The study continues through July, 2008.

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00007098

Sponsors and Collaborators
Investigators
Investigator: Alan Sinaiko University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00007098     History of Changes
Obsolete Identifiers: NCT00143897
Other Study ID Numbers: 955
Study First Received: December 7, 2000
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Hypertension
Insulin Resistance
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014