The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
Primary Purpose
Endothelial Dysfunction, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Eplerenone
Sponsored by
About this trial
This is an interventional basic science trial for Endothelial Dysfunction focused on measuring Endothelial dysfunction, Insulin resistance, Type 2 diabetes, Mineralocorticoid blocker
Eligibility Criteria
Inclusion Criteria:
- Diagnosed diabetic < 5 Yrs.
- BMI < 32 kg/m2
- Non-smoking
- Blood pressure < 140/90 mmHg (treatment with maximum of two antihypertensive drugs)
Exclusion Criteria:
- Insulin treatment
- Hypertension (>140/90 mmHg)
- Sequelae to diabetes
- Smoking
- Known chronic diseases
- Pregnancy or birth within 3 month
- Alcohol misuse
Sites / Locations
- Cardiovascular and Renal Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Type 2 Diabetes
Healthy
Arm Description
8 weeks of treatment with Aldosterone blocker Eplerenone
8 weeks of treatment with Aldosterone blocker Eplerenone
Outcomes
Primary Outcome Measures
Vascular function
Femoral arterial blood flow in response to femoral arterially infused ACh
Insulin sensitivity measured by a insulin clamp
Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp
Secondary Outcome Measures
Vascular function
Microperfusion performed on blood vessels in vitro obtained from muscle biopsies
Full Information
NCT ID
NCT03017703
First Posted
January 2, 2017
Last Updated
May 28, 2021
Sponsor
University of Southern Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03017703
Brief Title
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
Official Title
The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern Denmark
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endothelial Dysfunction, Insulin Resistance
Keywords
Endothelial dysfunction, Insulin resistance, Type 2 diabetes, Mineralocorticoid blocker
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 2 Diabetes
Arm Type
Experimental
Arm Description
8 weeks of treatment with Aldosterone blocker Eplerenone
Arm Title
Healthy
Arm Type
Experimental
Arm Description
8 weeks of treatment with Aldosterone blocker Eplerenone
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Primary Outcome Measure Information:
Title
Vascular function
Description
Femoral arterial blood flow in response to femoral arterially infused ACh
Time Frame
8 weeks
Title
Insulin sensitivity measured by a insulin clamp
Description
Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Vascular function
Description
Microperfusion performed on blood vessels in vitro obtained from muscle biopsies
Time Frame
8 weeks
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:
Diagnosed diabetic < 5 Yrs.
BMI < 32 kg/m2
Non-smoking
Blood pressure < 140/90 mmHg (treatment with maximum of two antihypertensive drugs)
Exclusion Criteria:
Insulin treatment
Hypertension (>140/90 mmHg)
Sequelae to diabetes
Smoking
Known chronic diseases
Pregnancy or birth within 3 month
Alcohol misuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan P Mortensen, DMSc
Organizational Affiliation
University of Southern Denmark
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
Plan to Share IPD
No
Citations:
PubMed Identifier
34350730
Citation
Finsen SH, Hansen MR, Hoffmann-Petersen J, Hojgaard HF, Mortensen SP. Eight weeks of mineralocorticoid blockade does not improve insulin sensitivity in type 2 diabetes. Physiol Rep. 2021 Aug;9(15):e14971. doi: 10.14814/phy2.14971.
Results Reference
derived
PubMed Identifier
33247722
Citation
Finsen SH, Hansen MR, Hansen PBL, Mortensen SP. Aldosterone Induces Vasoconstriction in Individuals with Type 2 Diabetes: Effect of Acute Antioxidant Administration. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1262-e1270. doi: 10.1210/clinem/dgaa867.
Results Reference
derived
Learn more about this trial
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
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