Back to resultsEffect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
Primary Purpose
Hyperinsulinemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperinsulinemia focused on measuring BQ-123, Endothelin, Insulin, Plethysmography, Vasoconstriction, Healthy Volunteer
Eligibility Criteria
Between 40-65 years old. No medications. No medical problems. No serum cholesterol levels below 200 mg/dl. No contraceptives.
Sites / Locations
- National Heart, Lung and Blood Institute (NHLBI)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001624
First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00001624
Brief Title
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
Official Title
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 1999
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperinsulinemia
Keywords
BQ-123, Endothelin, Insulin, Plethysmography, Vasoconstriction, Healthy Volunteer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Enrollment
16 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Insulin
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Between 40-65 years old.
No medications.
No medical problems.
No serum cholesterol levels below 200 mg/dl.
No contraceptives.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7916401
Citation
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.
Results Reference
background
PubMed Identifier
7788903
Citation
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.
Results Reference
background
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Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
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