NCT00005754

Brief Summary

To investigate the occurrence and associated risk factors for subclinical heart disease in persons with insulin-dependent diabetes mellitus (IDDM).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,420

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1999

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

September 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2000

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

8.8 years

First QC Date

May 25, 2000

Last Update Submit

June 8, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Progression of coronary artery calcification

    12 years

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

656 IDDM patients aged 20-55 years and 764 of their non-diabetic spouse/partner controls

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 (6)

  • Hokanson JE, Cheng S, Snell-Bergeon JK, Fijal BA, Grow MA, Hung C, Erlich HA, Ehrlich J, Eckel RH, Rewers M. A common promoter polymorphism in the hepatic lipase gene (LIPC-480C>T) is associated with an increase in coronary calcification in type 1 diabetes. Diabetes. 2002 Apr;51(4):1208-13. doi: 10.2337/diabetes.51.4.1208.

    PMID: 11916946BACKGROUND
  • Wadwa RP, Kinney GL, Maahs DM, Snell-Bergeon J, Hokanson JE, Garg SK, Eckel RH, Rewers M. Awareness and treatment of dyslipidemia in young adults with type 1 diabetes. Diabetes Care. 2005 May;28(5):1051-6. doi: 10.2337/diacare.28.5.1051.

    PMID: 15855566BACKGROUND
  • Maahs DM, Kinney GL, Wadwa P, Snell-Bergeon JK, Dabelea D, Hokanson J, Ehrlich J, Garg S, Eckel RH, Rewers MJ. Hypertension prevalence, awareness, treatment, and control in an adult type 1 diabetes population and a comparable general population. Diabetes Care. 2005 Feb;28(2):301-6. doi: 10.2337/diacare.28.2.301.

    PMID: 15677783BACKGROUND
  • Horton WB, Snell-Bergeon JK. Hemoglobin A1c Variability Metrics Predict Coronary Artery Calcium and Cardiovascular Events in Type 1 Diabetes: The CACTI Study. J Clin Endocrinol Metab. 2023 Jun 16;108(7):e444-e449. doi: 10.1210/clinem/dgad019.

  • Basu A, Alman AC, Snell-Bergeon JK. Associations of Dietary Antioxidants with Glycated Hemoglobin and Insulin Sensitivity in Adults with and without Type 1 Diabetes. J Diabetes Res. 2022 Jun 25;2022:4747573. doi: 10.1155/2022/4747573. eCollection 2022.

  • Basu A, Chien LC, Alman AC, Snell-Bergeon JK. Associations of dietary patterns and nutrients with coronary artery calcification and pericardial adiposity in a longitudinal study of adults with and without type 1 diabetes. Eur J Nutr. 2021 Oct;60(7):3911-3925. doi: 10.1007/s00394-021-02564-6. Epub 2021 Apr 27.

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesCoronary DiseaseDiabetes MellitusDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Marian Rewers, MD, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 25, 2000

First Posted

May 26, 2000

Study Start

September 1, 1999

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

June 10, 2015

Record last verified: 2015-06