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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
University of Southern Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
January 2, 2017
Last Updated
May 28, 2021
Sponsor
University of Southern Denmark
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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

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The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

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