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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00001624
Other study ID # 970100
Secondary ID 97-H-0100
Status Completed
Phase Phase 1
First received November 3, 1999
Last updated March 3, 2008
Start date March 1997
Est. completion date March 2000

Study information

Verified date February 1999
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date March 2000
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Between 40-65 years old.

No medications.

No medical problems.

No serum cholesterol levels below 200 mg/dl.

No contraceptives.

Study Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Insulin


Locations

Country Name City State
United States National Heart, Lung and Blood Institute (NHLBI) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Haynes WG, Webb DJ. Contribution of endogenous generation of endothelin-1 to basal vascular tone. Lancet. 1994 Sep 24;344(8926):852-4. — View Citation

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