Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes

NCT04907838 — Not applicable, Unknown, 22 participants, University of Southern Denmark

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT04907838
Status	Unknown
Phase	Not applicable
Study type	Interventional; non randomized, parallel, masking: none, basic science
Enrollment	22 (Actual)
Sponsor	University of Southern Denmark (Other); collaborators: The University of Texas at Arlington
Conditions	Type2 Diabetes
Interventions	Insulin clamp, BQ123, BQ123 + BQ788 (Drug)
Dates	start 2018-05-01, primary completion 2021-07-30 (estimated), completion 2021-07-30 (estimated), first posted 2021-06-01, last updated 2021-06-01
Locations	1 site in Denmark

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Type 2 diabetics	Experimental	Drug: Insulin clamp; Drug: BQ123; Drug: BQ123 + BQ788	BQ123 (25 nmol/min), BQ788 (25 nmol/min)
Healthy controls	Experimental	Drug: Insulin clamp; Drug: BQ123; Drug: BQ123 + BQ788	BQ123 (25 nmol/min), BQ788 (25 nmol/min)

Insulin clamp (Drug): Continous infusion insulin + glucose
BQ123 (Drug): Continuous infusion of Insulin + glucose + BQ123
BQ123 + BQ788 (Drug): Continous infusion of insulin + glucose + BQ123 + BQ788

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All, ages: 40 Years to 65 Years, accepts healthy volunteers

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)

+Locations (1)

Facility	City	Country	Status
Cardiovascular and Renal Research	Odense	Denmark

+Publications

Results publication: 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 35084435

+Investigators

Stefan Mortensen, DMSc, Principal investigator, Professor