Effect of Insulin on Endothelin-Dependent Vascular Tone i... | NCT00001624

Studies
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation

NCT00001624

Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Status

Completed

Last Update Posted

Mar 4, 2008Estimated

Enrollment

Phase

Phase 1

Conditions

Hyperinsulinemia

Interventions

Insulin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
97-H-0100

Status Module

Record Verification Date

Feb 1999

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1997

Primary Completion Date

Not provided

Completion Date

Mar 2000

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Dec 9, 2002

First Posted Date

Dec 10, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2008

Last Update Posted Date

Mar 4, 2008Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Insulin	Drug

Eligibility Module

Eligibility Criteria

Between 40-65 years old.

No medications.

No medical problems.

No serum cholesterol levels below 200 mg/dl.

No contraceptives.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Heart, Lung and Blood Institute (NHLBI)		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
7916401	Background	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.
7788903	Background	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.

ID	Term
D006946	Hyperinsulinism
D007333	Insulin Resistance

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D011384	Proinsulin
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones