The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

• Sponsor: University of Southern Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT03017703
• Collaborator: (none)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 36.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Dec 1, 2016
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Dec 15, 2019

Arms and Interventions

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

Primary Outcome Measures

1. Vascular function [8 weeks]

   Femoral arterial blood flow in response to femoral arterially infused ACh

2. Insulin sensitivity measured by a insulin clamp [8 weeks]

   Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp

Secondary Outcome Measures

1. Vascular function [8 weeks]

   Microperfusion performed on blood vessels in vitro obtained from muscle biopsies

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Cardiovascular and Renal Research	Odense		Denmark	5000

Sponsors and Collaborators

• University of Southern Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stefan Mortensen, Associate Professor, University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT03017703
• Other Study ID Numbers: H- 15007940
• First Posted: Jan 11, 2017
• Last Update Posted: Jun 2, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Stefan Mortensen, Associate Professor, University of Southern Denmark: Endothelial dysfunction; Insulin resistance; Type 2 diabetes; Mineralocorticoid blocker
• Additional relevant MeSH terms: Insulin Resistance; Eplerenone

Study Results

No Results Posted as of Jun 2, 2021