Improving Glycaemic Control With L-carnitine

Study Overview
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Brief Summary
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A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance). Insulin resistance can be caused by the accumulation of fat within muscle of overweight individuals. The aim of the present research is to test whether a novel nutritional intervention containing L-carnitine can increase the amount of carnitine within muscle of individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning fat' within our muscles and it is hoped that increasing the amount of carnitine within muscle can increase fat burning, lower muscle fat, reverse insulin resistance and ultimately lower blood glucose levels and wellbeing. We also aim to investigate the cellular mechanisms underlying any observed effects in a hope to identify further targets to lower muscle fat.

Official Title
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Increasing Skeletal Muscle Carnitine Content to Improve Glycaemic Control in Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Dietary Supplement: L-carnitine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index (BMI) 27-37 kg/m2 Male Age 18-60 years old Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58 mmol/mol) on diet therapy or metformin alone Not taking anti-diabetes medication other than metformin Understand verbal and/or written explanation of the study requirements Exclusion Criteria: Malignancy (excluding localised basal and squamous cell skin cancer) Metabolic diseases (stable treated hypothyroidism allowed) Active cardiovascular disease (current angina, myocardial infarct, or coronary artery surgery/angioplasty within 12 months) Primary muscle disorders Cerebrovascular disease Neurological disease e.g. epilepsy, Parkinsons disease Active respiratory disease Active gastrointestinal or liver disease Renal impairment (eGFR <60 ml/min) Clotting dysfunction Anti-diabetes medication other than metformin Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle metabolism, or safety (e.g. anticoagulants) Any other conditions in addition to the above that the investigators consider may affect study measurements or safety

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carnitine<br>Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks | Dietary Supplement: L-carnitine<br> <br> |
| Placebo Comparator: Sugar pill<br>Oral administration of placebo sugar pill | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skeletal muscle total carnitine content |  | up to 24 weeks of L-carnitine supplementation |