The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?
1 other identifier
interventional
27
1 country
1
Brief Summary
The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 2, 2017
CompletedFirst Posted
Study publicly available on registry
January 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2019
CompletedJune 2, 2021
May 1, 2021
2.8 years
January 2, 2017
May 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Vascular function
Femoral arterial blood flow in response to femoral arterially infused ACh
8 weeks
Insulin sensitivity measured by a insulin clamp
Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp
8 weeks
Secondary Outcomes (1)
Vascular function
8 weeks
Study Arms (2)
Type 2 Diabetes
EXPERIMENTAL8 weeks of treatment with Aldosterone blocker Eplerenone
Healthy
EXPERIMENTAL8 weeks of treatment with Aldosterone blocker Eplerenone
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed diabetic \< 5 Yrs.
- BMI \< 32 kg/m2
- Non-smoking
- Blood pressure \< 140/90 mmHg (treatment with maximum of two antihypertensive drugs)
You may not qualify if:
- Insulin treatment
- Hypertension (\>140/90 mmHg)
- Sequelae to diabetes
- Smoking
- Known chronic diseases
- Pregnancy or birth within 3 month
- Alcohol misuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cardiovascular and Renal Research
Odense, 5000, Denmark
Related Publications (2)
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.
PMID: 34350730DERIVEDFinsen 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.
PMID: 33247722DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan P Mortensen, DMSc
University of Southern Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 2, 2017
First Posted
January 11, 2017
Study Start
December 1, 2016
Primary Completion
October 1, 2019
Study Completion
December 15, 2019
Last Updated
June 2, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share