Endothelial DysfunctionNCT03017703
The Role of Aldosterone in Circulatory Disorders Within Type 2 Diabetes
A study testing Eplerenone in people with Endothelial Dysfunction and Insulin Resistance, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Insulin Resistance
- What is being tested?
- Eplerenone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2016to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed diabetic < 5 Yrs.
- BMI < 32 kg/m2
- Non-smoking
- Blood pressure < 140/90 mmHg (treatment with maximum of two antihypertensive drugs)
Who cannot join
- Insulin treatment
- Hypertension (>140/90 mmHg)
- Sequelae to diabetes
- Smoking
- Known chronic diseases
- Pregnancy or birth within 3 month
- Alcohol misuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?
The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes
- Conditions
- Endothelial Dysfunction, Insulin Resistance
- Being tested
- Eplerenone
- Keywords
- Endothelial dysfunction, Insulin resistance, Type 2 diabetes, Mineralocorticoid blocker
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EplerenoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | Experimental | 8 weeks of treatment with Aldosterone blocker Eplerenone Receives: Drug: Eplerenone |
| Healthy | Experimental | 8 weeks of treatment with Aldosterone blocker Eplerenone Receives: Drug: Eplerenone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
Femoral arterial blood flow in response to femoral arterially infused ACh
Measured: 8 weeks
Insulin sensitivity measured by a insulin clamp
Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp
Measured: 8 weeks
Secondary outcomes (1)
Vascular function
Microperfusion performed on blood vessels in vitro obtained from muscle biopsies
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start1 Dec 2016
- Primary completion1 Oct 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Mortensen, University of Southern Denmark
- Investigators
- Stefan P Mortensen, DMSc, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017703
- Sponsor's protocol ID
- H- 15007940
- Status last verified
- May 2021
- First submitted
- 2 Jan 2017
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Iepsen UW, Hjortdal AR, Thuesen AD, Finsen SH, Hansen PBL, Mortensen SP. The role of T-type calcium channels in elderly human vascular function: A pilot randomized controlled trial. Exp Physiol. 2024 May;109(5):779-790. doi: 10.1113/EP091645. Epub 2024 Mar 6.
PubMed 38445814Finsen 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.
PubMed 34350730Finsen 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.
PubMed 33247722
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Aldosterone in Diabetes Related Vascular Disease, a New Therapeutic Target?
- ClinicalTrials.gov ID
- NCT03017703
- Acronym / sponsor ID
- H- 15007940
- Conditions
- Endothelial Dysfunction, Insulin Resistance
- Keywords
- Endothelial dysfunction, Insulin resistance, Type 2 diabetes, Mineralocorticoid blocker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The importance of Aldosterone for endothelial function and Insulin resistance observed within patients with type 2 diabetes
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | Experimental | Drug: Eplerenone8 weeks of treatment with Aldosterone blocker Eplerenone |
| Healthy | Experimental | Drug: Eplerenone8 weeks of treatment with Aldosterone blocker Eplerenone |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed diabetic < 5 Yrs.
- BMI < 32 kg/m2
- Non-smoking
- Blood pressure < 140/90 mmHg (treatment with maximum of two antihypertensive drugs)
Key exclusion criteria (7 listed)
- Insulin treatment
- Hypertension (>140/90 mmHg)
- Sequelae to diabetes
- Smoking
- Known chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eplerenone | Drug | Healthy, Type 2 Diabetes |
Primary outcome
Vascular function
Time frame: 8 weeks
Femoral arterial blood flow in response to femoral arterially infused ACh
Insulin sensitivity measured by a insulin clamp
Time frame: 8 weeks
Glucose infusion rate during euglycaemic-hyperinsulinaemic clamp
1 secondary outcome
Vascular function
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Derived from this study: PubMed 38445814Iepsen UW, Hjortdal AR, Thuesen AD, Finsen SH, Hansen PBL, Mortensen SP. The role of T-type calcium channels in elderly human vascular function: A pilot randomized controlled trial. Exp Physiol. 2024 May;109(5):779-790. doi: 10.1113/EP091645. Epub 2024 Mar 6.
- Derived from this study: PubMed 34350730Finsen 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.
- Derived from this study: PubMed 33247722Finsen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan P Mortensen, DMSc principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eplerenone in people with Endothelial Dysfunction and Insulin Resistance, run by University of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular function (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03017703, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.