- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001624
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
March 3, 2008 updated by: National Heart, Lung, and Blood Institute (NHLBI)
Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells.
This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia.
The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation.
To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin.
We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.
Study Overview
Detailed Description
Previous studies have shown that insulin may stimulate the release of endothelin (ET) from endothelial cells.
This mechanism may contribute to the adverse vascular effects determined by chronic hyperinsulinemia.
The aim of this study will be to evaluate the effect of local hyperinsulinemia on ET activity in the forearm circulation.
To this purpose, we will assess the forearm blood flow response to ET receptor antagonism in control conditions and during intraarterial infusion of insulin.
We will also measure changes in plasma ET-1 levels in response to the different pharmacological stimuli.
Study Type
Interventional
Enrollment
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Maryland
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Bethesda, Maryland, United States, 20892
- National Heart, Lung and Blood Institute (NHLBI)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Between 40-65 years old.
No medications.
No medical problems.
No serum cholesterol levels below 200 mg/dl.
No contraceptives.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Haynes WG, Webb DJ. Contribution of endogenous generation of endothelin-1 to basal vascular tone. Lancet. 1994 Sep 24;344(8926):852-4. doi: 10.1016/s0140-6736(94)92827-4.
- Donckier J, Stoleru L, Hayashida W, Van Mechelen H, Selvais P, Galanti L, Clozel JP, Ketelslegers JM, Pouleur H. Role of endogenous endothelin-1 in experimental renal hypertension in dogs. Circulation. 1995 Jul 1;92(1):106-13. doi: 10.1161/01.cir.92.1.106.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1997
Study Completion
March 1, 2000
Study Registration Dates
First Submitted
November 3, 1999
First Submitted That Met QC Criteria
December 9, 2002
First Posted (Estimate)
December 10, 2002
Study Record Updates
Last Update Posted (Estimate)
March 4, 2008
Last Update Submitted That Met QC Criteria
March 3, 2008
Last Verified
February 1, 1999
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 970100
- 97-H-0100
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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