CClinicalTrials.gg
CompletedNCT00007098Updated Dec 7, 2016

Influence of Insulin on BP Change During Adolescence

An observational study in Cardiovascular Diseases, Hypertension and Obesity, sponsored by University of Minnesota. Completed. Open to participants aged 10 Years to 20 Years. Per ClinicalTrials.gov, last updated 2016-12-07.

Sponsored by University of Minnesota · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2
Ages
10 Years to 20 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Cardiovascular Diseases
  • Hypertension
  • Obesity
  • Insulin Resistance
  • Diabetes Mellitus
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.

This study's enrollment of 2 is below the median of 573 across 1,483 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Subjects with HBP

Eligibility criteria

No eligibility criteria

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2 participants (actual)
06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • Steinberger J, Moller JH, Berry JM, Sinaiko AR. Echocardiographic diagnosis of heart disease in apparently healthy adolescents. Pediatrics. 2000 Apr;105(4 Pt 1):815-8. doi: 10.1542/peds.105.4.815. PubMed 10742325 ↗
  • Moran A, Jacobs DR Jr, Steinberger J, Hong CP, Prineas R, Luepker R, Sinaiko AR. Insulin resistance during puberty: results from clamp studies in 357 children. Diabetes. 1999 Oct;48(10):2039-44. doi: 10.2337/diabetes.48.10.2039. PubMed 10512371 ↗
  • Sinaiko AR, Steinberger J, Moran A, Prineas RJ, Jacobs DR Jr. Relation of insulin resistance to blood pressure in childhood. J Hypertens. 2002 Mar;20(3):509-17. doi: 10.1097/00004872-200203000-00027. PubMed 11875319 ↗
  • Sinaiko AR, Jacobs DR Jr, Steinberger J, Moran A, Luepker R, Rocchini AP, Prineas RJ. Insulin resistance syndrome in childhood: associations of the euglycemic insulin clamp and fasting insulin with fatness and other risk factors. J Pediatr. 2001 Nov;139(5):700-7. doi: 10.1067/mpd.2001.118535. PubMed 11713450 ↗
  • Moran A, Sinaiko AR. Influence of intrauterine environment on development of insulin resistance. J Pediatr. 2000 May;136(5):567-9. doi: 10.1067/mpd.2000.106561. No abstract available. PubMed 10802482 ↗
  • Moran A, Jacobs DR Jr, Steinberger J, Cohen P, Hong CP, Prineas R, Sinaiko AR. Association between the insulin resistance of puberty and the insulin-like growth factor-I/growth hormone axis. J Clin Endocrinol Metab. 2002 Oct;87(10):4817-20. doi: 10.1210/jc.2002-020517. PubMed 12364479 ↗
  • Schmitz KH, Jacobs DR Jr, Hong CP, Steinberger J, Moran A, Sinaiko AR. Association of physical activity with insulin sensitivity in children. Int J Obes Relat Metab Disord. 2002 Oct;26(10):1310-6. doi: 10.1038/sj.ijo.0802137. PubMed 12355326 ↗
  • Murtaugh MA, Jacobs DR Jr, Moran A, Steinberger J, Sinaiko AR. Relation of birth weight to fasting insulin, insulin resistance, and body size in adolescence. Diabetes Care. 2003 Jan;26(1):187-92. doi: 10.2337/diacare.26.1.187. PubMed 12502679 ↗
  • Steinberger J, Jacobs DR, Moran A, Hong CP, Rocchini AP, Prineas RJ, Sinaiko AR. Relation of insulin resistance and body composition to left ventricular mass in children. Am J Cardiol. 2002 Nov 15;90(10):1177-80. doi: 10.1016/s0002-9149(02)02795-9. No abstract available. PubMed 12423731 ↗
  • Steinberger J, Steffen L, Jacobs DR Jr, Moran A, Hong CP, Sinaiko AR. Relation of leptin to insulin resistance syndrome in children. Obes Res. 2003 Sep;11(9):1124-30. doi: 10.1038/oby.2003.153. PubMed 12972683 ↗
  • Steffen LM, Jacobs DR Jr, Murtaugh MA, Moran A, Steinberger J, Hong CP, Sinaiko AR. Whole grain intake is associated with lower body mass and greater insulin sensitivity among adolescents. Am J Epidemiol. 2003 Aug 1;158(3):243-50. doi: 10.1093/aje/kwg146. PubMed 12882946 ↗
  • Pankow JS, Jacobs DR Jr, Steinberger J, Moran A, Sinaiko AR. Insulin resistance and cardiovascular disease risk factors in children of parents with the insulin resistance (metabolic) syndrome. Diabetes Care. 2004 Mar;27(3):775-80. doi: 10.2337/diacare.27.3.775. PubMed 14988301 ↗
  • Sinaiko AR, Steinberger J, Moran A, Prineas RJ, Vessby B, Basu S, Tracy R, Jacobs DR Jr. Relation of body mass index and insulin resistance to cardiovascular risk factors, inflammatory factors, and oxidative stress during adolescence. Circulation. 2005 Apr 19;111(15):1985-91. doi: 10.1161/01.CIR.0000161837.23846.57. PubMed 15837953 ↗

Individual participant data

Plan to share: Undecided

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00007098
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Dec 8, 2000
Start date
May 1995
Primary completion
Jul 2008
Completion
Jul 2008
Last update
Dec 7, 2016

Study contacts

Alan Sinaiko
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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