Diabetic CardiomyopathyPhase 1/2DDCMNCT00628056
Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
A Phase 1/2 study testing Perhexiline in people with Diabetic Cardiomyopathy, run by University Hospital Birmingham at 1 site in United Kingdom.
Trial summary
Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Diabetic Cardiomyopathy
- What is being tested?
- Perhexiline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2006to Apr 2009
- Phase
- Phase 1/2
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes Mellitus(WHO definition)
- HbA1C <9
- No history of chest pain
- No evidence of Coronary Artery Disease or peripheral vascular disease
- Left ventricular ejection fraction over 50%
- No evidence of respiratory disease
Who cannot join
- Patients < 16years or who cannot provide informed consent
- Evidence of significant epicardial coronary artery disease
- Evidence of peripheral vascular disease
- Abnormal liver function tests
- Clinically apparent peripheral neuropathy
- Severe chronic renal failure (creatinine >250) or diabetic nephropathy
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- Concomitant use of Amiodarone, Quinidine, Haloperidol or Selective serotonin (5HT) uptake inhibitors such as Fluoxetine and Paroxetine which may inhibit the CYP2D6 enzyme
- Patients on statin therapy for primary dyslipidemia.
- Patients with recurrent hypoglycaemia
- Women of child bearing age who are not using effective contraception (or if pregnancy test positive)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Birmingham
Birmingham, Westmidlands, B15 2TT
Michael Frenneaux, MD FRCP FACC
About this study
Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.
- Conditions
- Diabetic Cardiomyopathy
- Being tested
- Perhexiline
- Keywords
- Perhexiline, diabetes, diabetic cardiomyopathy, high energy phosphate kinetics, magnetic resonance spectroscopy
- Medical subject headings
- Diabetic Cardiomyopathies, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerhexilineDrug
Intervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: Perhexiline |
| 2 | Placebo comparator | Not described Receives: Drug: Perhexiline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2008 (estimated)
- Study startOct 2006
- Primary completionApr 2009 (estimated)
- Study completionApr 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic CardiomyopathyStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Investigators
- Michael Frenneaux, MD FRCP FACC, Principal investigator, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628056
- Sponsor's protocol ID
- RRK3159
- Other IDs
- PG/06/104/21466
- Acronym
- DDCM
- Status last verified
- Feb 2008
- First submitted
- 24 Feb 2008
- Last updated
- 4 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Responsible for Cardiac and Skeletal Muscle Energetic Impairment in Diabetes
- ClinicalTrials.gov ID
- NCT00628056
- Acronym / sponsor ID
- DDCM / RRK3159
- Conditions
- Diabetic Cardiomyopathy
- Keywords
- Perhexiline, diabetes, diabetic cardiomyopathy, high energy phosphate kinetics, magnetic resonance spectroscopy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital BirminghamUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Oct 2006
- Primary completion
- Apr 2009 (estimated)
- Study completion
- Apr 2009 (estimated)
- First posted
- 4 Mar 2008 (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.
Diabetes increases the risk of heart failure. This is mainly due to a disease of the blood vessels supplying the heart muscle and/or high blood pressure, but abnormal metabolism may also contribute. We plan to study the mechanisms involved in this abnormal metabolism, whilst also assessing the effects of a drug called Perhexiline which improves the abnormal metabolism that is present in diabetic patients before the development of heart failure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Perhexiline |
| 2 | Placebo comparator | Drug: Perhexiline |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Diabetes Mellitus(WHO definition)
- HbA1C <9
- No history of chest pain
- No evidence of Coronary Artery Disease or peripheral vascular disease
- Left ventricular ejection fraction over 50%
Key exclusion criteria (10 listed)
- Patients < 16years or who cannot provide informed consent
- Evidence of significant epicardial coronary artery disease
- Evidence of peripheral vascular disease
- Abnormal liver function tests
- Clinically apparent peripheral neuropathy
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 |
|---|---|---|
| PerhexilineIntervention with Perhexiline/Placebo at 100mg twice a day for 2 weeks | Drug | 1, 2 |
Primary outcome
The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio.
Time frame: 2 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
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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.
Michael Frenneaux, MD FRCP FACC principal investigator
University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Perhexiline in people with Diabetic Cardiomyopathy, run by University Hospital Birmingham at 1 site in United Kingdom.
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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 4 Mar 2008. 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 United Kingdom. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ganesh Nallur Shivu, MBBS MRCP (0044 1214145916, drgani23@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary end point of the Perhexiline intervention study will be the change in cardiac PCr/ATP ratio. (time frame: 2 Weeks). 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 4 Mar 2008.