Status:
COMPLETED
Cross-over Study on Effect of Lipid Lowering by Acipimox on Cardiac and Skeletal Muscle Mitochondrial Function
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Center for Translational Molecular Medicine
Conditions:
Diabetes Mellitus, Type 2
Cardiomyopathy, Dilated
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
Accumulation of lipid in skeletal and cardiac muscle has been associated with insulin resistance and diabetic cardiomyopathy. In skeletal muscle, lipotoxic damage has been suggested to lead to dysfunc...
Eligibility Criteria
Inclusion
- Male or postmenopausal females
- Age 40-70 years
- Obese (BMI \> 30 kg/m2), non-insulin dependent type 2 diabetic patients and BMI matched control subjects without diabetes.
- Generally healthy with specifically no known cardiovascular disease, dyslipidemia, or gastric ulcers (contra-ind. of Acipimox), which can affect the study parameters.
- Must be on sulphonylurea(SU)- derivate or metformin therapy for at least six months with a constant dose for at least two months, or on dietary treatment for at least six months
- Well-controlled diabetes: HbA1c\<8%.
- Control subjects must have a plasma glucose lower than 6,1 mmol/L.
- Stable dietary habits (no weight loss/gain \> 3 kg in the last 6 months)
Exclusion
- Known cardiovascular disease, dyslipidemia, hepatic or renal failure and gastric ulcers.
- Insulin dependent Diabetic patients.
- Use of lipid lowering agents, except from Statins, as these do not affect triglycerides levels (with exception to Lipitor).
- Use of Thiazolidines (glitazone/rosiglitazone/pioglitazone/troglitazone)
- Use of anti-coagulants (not thrombocyte-aggregation inhibitors)
- Aberrant ECG (with signs of ischemia or cardiac failure or arrythmia's)
- Weight gain/loss \> 3 kg in the last 6 months.
- Hb \< 7,3 in women, and \< 7,8 in men.
- Contraindications for MRI scans:
- Electronic implants such as pacemakers or neurostimulator
- Iron-containing corpora aliena in eyes or brain
- Some hearing aids and artificial (heart) valves which are contraindicated for MRS
- Claustrophobia
- Subjects, who do not want to be informed about unexpected medical findings, or do not wish that their physician is informed, cannot participate in the study.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00943059
Start Date
March 1 2010
End Date
December 1 2012
Last Update
May 14 2013
Active Locations (1)
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1
Maastricht University Medical Centre
Maastricht, Netherlands, 6200MD