Type 2 Diabetes MellitusPhase 3NCT00527995
Acute Effects of Sildenafil on Endothelial Function in People With Diabetes
A Phase 3 study testing Sildenafil in people with Type 2 Diabetes Mellitus and Endothelial Dysfunction, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous… Read more about this study
- Who is it for?
- Ages 35 to 70 years, men only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Endothelial Dysfunction
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2001to Jun 2003
- Phase
- Phase 3
- 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 35 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 35-70
- type 2 diabetes mellitus
- impotence
- with and without hypertension, hypercholesteremia
Who cannot join
- patients with history of cardiovascular and malignant disease,
- advanced nephropathy (creatinine≥2.2mg/dl)
- hepatopathy (liver enzymes higher than the double of normal values)
- patients taking nitrates
- CHF: NYHA > II
- Stable angina: CCS > II
Trial locations and contacts
1 site in 1 country.
Germany1 site
German Diabetes Center
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official title: Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients
This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.
- Conditions
- Type 2 Diabetes Mellitus, Endothelial Dysfunction
- Being tested
- Sildenafil
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra
Orally administered, Sildenafil 100mg, unique administration
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.
Measured: 60 minutes
Secondary outcomes (1)
Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2007 (estimated)
- Study startAug 2001
- Study completionJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Investigators
- Alin Stirban, MD, Principal investigator, Heart and Diabetes Center NRWDan Ziegler, MD, Study director, German Diabetes Center Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00527995
- Sponsor's protocol ID
- Sildenafil_ED_2001
- Status last verified
- Sep 2007
- First submitted
- 10 Sep 2007
- Last updated
- 11 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00527995
- Acronym / sponsor ID
- Sildenafil_ED_2001
- Conditions
- Type 2 Diabetes Mellitus, Endothelial Dysfunction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Aug 2001
- Study completion
- Jun 2003 (actual)
- First posted
- 11 Sep 2007 (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.
This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 35-70
- type 2 diabetes mellitus
- impotence
- with and without hypertension, hypercholesteremia
Key exclusion criteria (6 listed)
- patients with history of cardiovascular and malignant disease,
- advanced nephropathy (creatinine≥2.2mg/dl)
- hepatopathy (liver enzymes higher than the double of normal values)
- patients taking nitrates
- CHF: NYHA > II
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 |
|---|---|---|
| SildenafilAlso: ViagraOrally administered, Sildenafil 100mg, unique administration | Drug | – |
Primary outcome
Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.
Time frame: 60 minutes
1 secondary outcome
Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil.
Time frame: 60 minutes
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 11 Sep 2007.
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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.
Alin Stirban, MD principal investigator
Heart and Diabetes Center NRW
Dan Ziegler, MD study director
German Diabetes Center Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil in people with Type 2 Diabetes Mellitus and Endothelial Dysfunction, run by Ruhr University of Bochum at 1 site in Germany.
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 6 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 11 Sep 2007. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil. (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2007.