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Influence of Insulin on BP Change During Adolescence

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007098
First Posted: December 8, 2000
Last Update Posted: December 7, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Enrollment: 2
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

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with HBP
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00007098


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

Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00007098     History of Changes
Obsolete Identifiers: NCT00143897
Other Study ID Numbers: 955
First Submitted: December 7, 2000
First Posted: December 8, 2000
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism