The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

May 28, 2021 updated by: Stefan Mortensen, University of Southern Denmark

The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?

The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Cardiovascular and Renal Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular function
Time Frame: 8 weeks
Femoral arterial blood flow in response to femoral arterially infused ACh
8 weeks
Insulin sensitivity measured by a insulin clamp
Time Frame: 8 weeks
Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vascular function
Time Frame: 8 weeks
Microperfusion performed on blood vessels in vitro obtained from muscle biopsies
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Principal Investigator: Stefan P Mortensen, DMSc, University of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

December 15, 2019

Study Registration Dates

First Submitted

January 2, 2017

First Submitted That Met QC Criteria

January 9, 2017

First Posted (Estimate)

January 11, 2017

Study Record Updates

Last Update Posted (Actual)

June 2, 2021

Last Update Submitted That Met QC Criteria

May 28, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H- 15007940

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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