The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes

NCT ID: NCT03017703

Last Updated: 2021-06-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2019-12-15

Brief Summary

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

Detailed Description

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Conditions

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Endothelial Dysfunction Insulin Resistance

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Type 2 Diabetes

8 weeks of treatment with Aldosterone blocker Eplerenone

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

Healthy

8 weeks of treatment with Aldosterone blocker Eplerenone

Group Type EXPERIMENTAL

Eplerenone

Intervention Type DRUG

Interventions

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Eplerenone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Southern Denmark

OTHER

Sponsor Role lead

Responsible Party

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Stefan Mortensen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan P Mortensen, DMSc

Role: PRINCIPAL_INVESTIGATOR

University of Southern Denmark

Locations

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Cardiovascular and Renal Research

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Finsen SH, Hansen MR, Hoffmann-Petersen J, Hojgaard HF, Mortensen SP. Eight weeks of mineralocorticoid blockade does not improve insulin sensitivity in type 2 diabetes. Physiol Rep. 2021 Aug;9(15):e14971. doi: 10.14814/phy2.14971.

Reference Type DERIVED
PMID: 34350730 (View on PubMed)

Finsen SH, Hansen MR, Hansen PBL, Mortensen SP. Aldosterone Induces Vasoconstriction in Individuals with Type 2 Diabetes: Effect of Acute Antioxidant Administration. J Clin Endocrinol Metab. 2021 Mar 8;106(3):e1262-e1270. doi: 10.1210/clinem/dgaa867.

Reference Type DERIVED
PMID: 33247722 (View on PubMed)

Other Identifiers

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H- 15007940

Identifier Type: -

Identifier Source: org_study_id

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