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OpenTrials
Completed

NCT Number: NCT03017703

The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

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

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Key information

Conditions

Endothelial Dysfunction Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular and Renal Research

Odense, 5000, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

Drug

Primary outcomes

  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 outcomes

  1. Vascular function

    Time frame: 8 weeks

    Microperfusion performed on blood vessels in vitro obtained from muscle biopsies

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2017
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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