Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes

May 28, 2021 updated by: Stefan Mortensen, University of Southern Denmark
This study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. The subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

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

  • Denmark
      • Odense, Denmark, 5000
        • Cardiovascular and Renal Research

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

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetes OR healthy control (no type 2 diabetes)
  • BMI<32

Exclusion Criteria:

  • heart disease
  • pregnancy or birth within 3 month
  • smoking
  • Kidney disease
  • beta-blockers
  • insulin treatment (for type 2 diabetics)

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Type 2 diabetics
BQ123 (25 nmol/min), BQ788 (25 nmol/min)
Drug: Insulin clamp
Continous infusion insulin + glucose
Drug: BQ123
Continuous infusion of Insulin + glucose + BQ123
Drug: BQ123 + BQ788
Continous infusion of insulin + glucose + BQ123 + BQ788
Experimental: Healthy controls
BQ123 (25 nmol/min), BQ788 (25 nmol/min)
Drug: Insulin clamp
Continous infusion insulin + glucose
Drug: BQ123
Continuous infusion of Insulin + glucose + BQ123
Drug: BQ123 + BQ788
Continous infusion of insulin + glucose + BQ123 + BQ788

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose infusion rate
Time Frame: 3.5 hours
Glucose infusion rate required to maintain euglycemia during insulin clamp with and without endothelin blockade
3.5 hours
Leg blood flow
Time Frame: 3.5 hours
Effect of endothelin receptor blockade on leg blood flow (ultrasound Doppler) during insulin clamp with and without endothelin blockade
3.5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Collaborators

The University of Texas at Arlington

Investigators

  • Principal Investigator: Stefan Mortensen, DMSc, PROFESSOR

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

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 (Actual)

May 1, 2018

Primary Completion (Anticipated)

July 30, 2021

Study Completion (Anticipated)

July 30, 2021

Study Registration Dates

First Submitted

May 4, 2019

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 1, 2021

Study Record Updates

Last Update Posted (Actual)

June 1, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • s-20180040

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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