Topic: Primary Care
Conditions
Interventions
Carnitine, Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-arnitine
Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks
Sponsors
Nottingham University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria patients with T2DM: 1. Body mass index (BMI) 27-37 kg/m2 2. Male 3. Age 18-60 years old 4. Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone 5. Not taking anti-diabetes medication other than metformin 6. Understand verbal and/or written explanation of the study requirements Inclusion criteria control participants: 1. Body mass index (BMI) 27-37 kg/m2 2. Male 3. Age 18-60 years old 4. Normal glucose tolerance (2 hour blood glucose <5.6 after screening OGTT) 5. Not taking anti-diabetes medication 6. Understand verbal and/or written explanation of the study requirements
Exclusion criteria
Exclusion criteria: 1. Malignancy (excluding localised basal and squamous cell skin cancer) 2. Metabolic diseases (stable treated hypothyroidism allowed) 3. Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months) 4. Primary muscle disorders 5. Cerebrovascular disease 6. Neurological disease e.g. epilepsy, Parkinsons disease 7. Active respiratory disease 8. Active gastrointestinal or liver disease 9. Renal impairment (eGFR <60 ml/min) 10. Clotting dysfunction 11. Anti-diabetes medication other than metformin 12. Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants) 13. Any other conditions in addition to the above that the investigators consider may affect study measurements or safety 14. Abnormalities on screening blood tests that in the view of the investigators are clinically significant 15. Any metallic implants that will affect the DEXA scan.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Skeletal muscle total carnitine content is measured at baseline and 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration | — |
Countries
United Kingdom
Outcome results
None listed