The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

Not Applicable

Completed

• Conditions: Insulin Resistance; Endothelial Dysfunction
• Interventions: Drug: Eplerenone

• Registration Number: NCT03017703
• Lead Sponsor: University of Southern Denmark

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-01-02
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Primary Completion: 2019-10-01
• Study Completion: 2019-12-15
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-28
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes	Eplerenone	8 weeks of treatment with Aldosterone blocker Eplerenone
Healthy	Eplerenone	8 weeks of treatment with Aldosterone blocker Eplerenone

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Vascular function	8 weeks	Microperfusion performed on blood vessels in vitro obtained from muscle biopsies

Trial Locations

Locations (1)

Cardiovascular and Renal Research; 🇩🇰 Odense, Denmark