NCT00007098

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 1995

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1995

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 8, 2000

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

December 7, 2016

Status Verified

December 1, 2016

Enrollment Period

13.2 years

First QC Date

December 7, 2000

Last Update Submit

December 6, 2016

Conditions

Eligibility Criteria

Age10 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Subjects with HBP

No eligibility criteria

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (13)

  • 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.

    PMID: 10742325BACKGROUND
  • 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.

    PMID: 10512371BACKGROUND
  • 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.

    PMID: 11875319BACKGROUND
  • 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.

    PMID: 11713450BACKGROUND
  • 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.

    PMID: 10802482BACKGROUND
  • 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.

    PMID: 12364479BACKGROUND
  • 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.

    PMID: 12355326BACKGROUND
  • 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.

    PMID: 12502679BACKGROUND
  • 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.

    PMID: 12423731BACKGROUND
  • 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.

    PMID: 12972683BACKGROUND
  • 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.

    PMID: 12882946BACKGROUND
  • 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.

    PMID: 14988301BACKGROUND
  • 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.

    PMID: 15837953BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHypertensionObesityInsulin ResistanceDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Alan Sinaiko

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2000

First Posted

December 8, 2000

Study Start

May 1, 1995

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

December 7, 2016

Record last verified: 2016-12