HyperinsulinemiaPhase 1NCT00001624
Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
A Phase 1 study testing Insulin in people with Hyperinsulinemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hyperinsulinemia
- What is being tested?
- Insulin
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Mar 2000
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Between 40-65 years old.
No medications.
No medical problems.
No serum cholesterol levels below 200 mg/dl.
No contraceptives.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, 20892
About this study
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.
Read the 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.
- Conditions
- Hyperinsulinemia
- Being tested
- Insulin
- Keywords
- BQ-123, Endothelin, Insulin, Plethysmography, Vasoconstriction, Healthy Volunteer
- Medical subject headings
- Hyperinsulinism, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMar 1997
- Study completionMar 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperinsulinemiaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Enrolment
- 16 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001624
- Sponsor's protocol ID
- 970100
- Other IDs
- 97-H-0100
- Status last verified
- Feb 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
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.
PubMed 7916401Donckier 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.
PubMed 7788903
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Insulin on Endothelin-Dependent Vascular Tone in the Forearm Circulation
- ClinicalTrials.gov ID
- NCT00001624
- Acronym / sponsor ID
- 970100
- Conditions
- Hyperinsulinemia
- Keywords
- BQ-123, Endothelin, Insulin, Plethysmography, Vasoconstriction, Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Mar 1997
- Study completion
- Mar 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 7916401Haynes 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.
- Background: PubMed 7788903Donckier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Insulin in people with Hyperinsulinemia, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001624, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.