NCT04907838

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 4, 2019

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2021

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

3.2 years

First QC Date

May 4, 2019

Last Update Submit

May 28, 2021

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Glucose infusion rate

    Glucose infusion rate required to maintain euglycemia during insulin clamp with and without endothelin blockade

    3.5 hours

  • Leg blood flow

    Effect of endothelin receptor blockade on leg blood flow (ultrasound Doppler) during insulin clamp with and without endothelin blockade

    3.5 hours

Study Arms (2)

Type 2 diabetics

EXPERIMENTAL

BQ123 (25 nmol/min), BQ788 (25 nmol/min)

Drug: Insulin clampDrug: BQ123Drug: BQ123 + BQ788

Healthy controls

EXPERIMENTAL

BQ123 (25 nmol/min), BQ788 (25 nmol/min)

Drug: Insulin clampDrug: BQ123Drug: BQ123 + BQ788

Interventions

Insulin clampDRUG

Continous infusion insulin + glucose

Healthy controlsType 2 diabetics
BQ123DRUG

Continuous infusion of Insulin + glucose + BQ123

Healthy controlsType 2 diabetics
BQ123 + BQ788DRUG

Continous infusion of insulin + glucose + BQ123 + BQ788

Healthy controlsType 2 diabetics

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular and Renal Research

Odense, 5000, Denmark

Location

Related Publications (1)

  • Young BE, Padilla J, Finsen SH, Fadel PJ, Mortensen SP. Role of Endothelin-1 Receptors in Limiting Leg Blood Flow and Glucose Uptake During Hyperinsulinemia in Type 2 Diabetes. Endocrinology. 2022 Mar 1;163(3):bqac008. doi: 10.1210/endocr/bqac008.

    PMID: 35084435DERIVED

MeSH Terms

Interventions

cyclo(Trp-Asp-Pro-Val-Leu)BQ 788

Study Officials

  • Stefan Mortensen, DMSc

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2019

First Posted

June 1, 2021

Study Start

May 1, 2018

Primary Completion

July 30, 2021

Study Completion

July 30, 2021

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations

DK(1)