NCT00005474

Brief Summary

To elucidate the biochemical, metabolic, and genetic markers and mechanisms of macrovascular disease in insulin dependent diabetes mellitus (IDDM).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,063

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1996

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, 1996

Completed
3.7 years 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
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 14, 2015

Status Verified

August 1, 2008

Enrollment Period

11.9 years

First QC Date

May 25, 2000

Last Update Submit

April 13, 2015

Conditions

Cardiovascular DiseasesDiabetes MellitusAtherosclerosisHeart DiseasesDiabetes Mellitus, Insulin-dependent

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with type 1 diabetes enrolled in the DCCT/EDIC cohort who agreed to participate in our sub-study were enrolled

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 (8)

  • Lopes HF, Stojiljkovic MP, Zhang D, Goodfriend TL, Egan BM. Moderate sodium restriction enhances the pressor response to hyperlipidemia in obese, hypertensive patients. J Clin Hypertens (Greenwich). 2002 May-Jun;4(3):173-80. doi: 10.1111/j.1524-6175.2002.00712.x.

    PMID: 12045366BACKGROUND

  • Lopes HF, Stojiljkovic MP, Zhang D, Goodfriend TL, Egan BM. The pressor response to acute hyperlipidemia is enhanced in lean normotensive offspring of hypertensive parents. Am J Hypertens. 2001 Oct;14(10):1032-7. doi: 10.1016/s0895-7061(01)02166-5.

    PMID: 11710782BACKGROUND

  • Garvey WT, Kwon S, Zheng D, Shaughnessy S, Wallace P, Hutto A, Pugh K, Jenkins AJ, Klein RL, Liao Y. Effects of insulin resistance and type 2 diabetes on lipoprotein subclass particle size and concentration determined by nuclear magnetic resonance. Diabetes. 2003 Feb;52(2):453-62. doi: 10.2337/diabetes.52.2.453.

    PMID: 12540621BACKGROUND

  • Stojiljkovic MP, Lopes HF, Zhang D, Morrow JD, Goodfriend TL, Egan BM. Increasing plasma fatty acids elevates F2-isoprostanes in humans: implications for the cardiovascular risk factor cluster. J Hypertens. 2002 Jun;20(6):1215-21. doi: 10.1097/00004872-200206000-00036.

    PMID: 12023694BACKGROUND

  • Jaffa AA, Durazo-Arvizu R, Zheng D, Lackland DT, Srikanth S, Garvey WT, Schmaier AH; DCCT/EDIC Study Group. Plasma prekallikrein: a risk marker for hypertension and nephropathy in type 1 diabetes. Diabetes. 2003 May;52(5):1215-21. doi: 10.2337/diabetes.52.5.1215.

    PMID: 12716755BACKGROUND

  • Nashar K, Nguyen JP, Jesri A, Morrow JD, Egan BM. Angiotensin receptor blockade improves arterial distensibility and reduces exercise-induced pressor responses in obese hypertensive patients with the metabolic syndrome. Am J Hypertens. 2004 Jun;17(6):477-82. doi: 10.1016/j.amjhyper.2004.02.015.

    PMID: 15177518BACKGROUND

  • Tan Y, Hutchison FN, Jaffa AA. Mechanisms of angiotensin II-induced expression of B2 kinin receptors. Am J Physiol Heart Circ Physiol. 2004 Mar;286(3):H926-32. doi: 10.1152/ajpheart.00757.2003.

    PMID: 14766673BACKGROUND

  • Lopes HF, Morrow JD, Stojiljkovic MP, Goodfriend TL, Egan BM. Acute hyperlipidemia increases oxidative stress more in African Americans than in white Americans. Am J Hypertens. 2003 May;16(5 Pt 1):331-6. doi: 10.1016/s0895-7061(03)00041-4.

    PMID: 12745192BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Both DNA samples as well as plasma, serum and urine samples were collected from the DCCT/EDIC cohort.

MeSH Terms

Conditions

Cardiovascular DiseasesDiabetes MellitusAtherosclerosisHeart DiseasesDiabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Maria Lopes-Virella

    Medical University of South Carolina

    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, 1996

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 14, 2015

Record last verified: 2008-08