Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
Primary Purpose
Type2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Insulin clamp
BQ123
BQ123 + BQ788
Sponsored by
About this trial
This is an interventional basic science trial for Type2 Diabetes
Eligibility Criteria
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)
Sites / Locations
- Cardiovascular and Renal Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Type 2 diabetics
Healthy controls
Arm Description
BQ123 (25 nmol/min), BQ788 (25 nmol/min)
BQ123 (25 nmol/min), BQ788 (25 nmol/min)
Outcomes
Primary Outcome Measures
Glucose infusion rate
Glucose infusion rate required to maintain euglycemia during insulin clamp with and without endothelin blockade
Leg blood flow
Effect of endothelin receptor blockade on leg blood flow (ultrasound Doppler) during insulin clamp with and without endothelin blockade
Secondary Outcome Measures
Full Information
NCT ID
NCT04907838
First Posted
May 4, 2019
Last Updated
May 28, 2021
Sponsor
University of Southern Denmark
Collaborators
The University of Texas at Arlington
1. Study Identification
Unique Protocol Identification Number
NCT04907838
Brief Title
Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
Official Title
Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
July 30, 2021 (Anticipated)
Study Completion Date
July 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
Collaborators
The University of Texas at Arlington
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 2 diabetics
Arm Type
Experimental
Arm Description
BQ123 (25 nmol/min), BQ788 (25 nmol/min)
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
BQ123 (25 nmol/min), BQ788 (25 nmol/min)
Intervention Type
Drug
Intervention Name(s)
Insulin clamp
Intervention Description
Continous infusion insulin + glucose
Intervention Type
Drug
Intervention Name(s)
BQ123
Intervention Description
Continuous infusion of Insulin + glucose + BQ123
Intervention Type
Drug
Intervention Name(s)
BQ123 + BQ788
Intervention Description
Continous infusion of insulin + glucose + BQ123 + BQ788
Primary Outcome Measure Information:
Title
Glucose infusion rate
Description
Glucose infusion rate required to maintain euglycemia during insulin clamp with and without endothelin blockade
Time Frame
3.5 hours
Title
Leg blood flow
Description
Effect of endothelin receptor blockade on leg blood flow (ultrasound Doppler) during insulin clamp with and without endothelin blockade
Time Frame
3.5 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan Mortensen, DMSc
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular and Renal Research
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
35084435
Citation
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.
Results Reference
derived
Learn more about this trial
Insulin Stimulated Vasodilation in Patients With Type 2 Diabetes
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