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NCT03017703 Clinical Trial

The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

Insulin Resistance Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03017703
Other study ID # H- 15007940
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date December 15, 2019

Study information
Verified date May 2021
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date December 15, 2019
Est. primary completion date October 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eplerenone

Locations
Country Name City State
Denmark Cardiovascular and Renal Research Odense

Sponsors (1)
Lead Sponsor Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vascular function Femoral arterial blood flow in response to femoral arterially infused ACh 8 weeks
Primary Insulin sensitivity measured by a insulin clamp Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp 8 weeks
Secondary Vascular function Microperfusion performed on blood vessels in vitro obtained from muscle biopsies 8 weeks
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