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The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017703
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : June 2, 2021
Sponsor:
Information provided by (Responsible Party):
Stefan Mortensen, University of Southern Denmark

Study Description
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Brief Summary:
The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes

Condition or disease Intervention/treatment Phase
Endothelial Dysfunction Insulin Resistance Drug: Eplerenone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : October 1, 2019
Actual Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Eplerenone

Arms and Interventions
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Arm Intervention/treatment
Experimental: Type 2 Diabetes
8 weeks of treatment with Aldosterone blocker Eplerenone
 Drug: Eplerenone
Experimental: Healthy
8 weeks of treatment with Aldosterone blocker Eplerenone
 Drug: Eplerenone


Outcome Measures
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Primary Outcome Measures :
  1. Vascular function [ Time Frame: 8 weeks ]
    Femoral arterial blood flow in response to femoral arterially infused ACh

  2. Insulin sensitivity measured by a insulin clamp [ Time Frame: 8 weeks ]
    Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp


Secondary Outcome Measures :
  1. Vascular function [ Time Frame: 8 weeks ]
    Microperfusion performed on blood vessels in vitro obtained from muscle biopsies


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017703


Locations
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Denmark
Cardiovascular and Renal Research
Odense, Denmark, 5000
Sponsors and Collaborators
University of Southern Denmark
Investigators
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Principal Investigator: Stefan P Mortensen, DMSc University of Southern Denmark
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stefan Mortensen, Associate Professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03017703    
Other Study ID Numbers: H- 15007940
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: June 2, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Stefan Mortensen, University of Southern Denmark:
Endothelial dysfunction
Insulin resistance
Type 2 diabetes
Mineralocorticoid blocker
Additional relevant MeSH terms:
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Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Eplerenone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents