Improving Glycaemic Control With L-carnitine

University of Nottingham

Status and phase: Unknown; Phase 2

Conditions: Type 2 Diabetes

Treatments: Dietary Supplement: Placebo; Dietary Supplement: L-carnitine

Study type: Interventional

Funder types: Other

Identifiers

NCT02197299

14/EM/0136

13/0004659 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Carnitine

Experimental group

Description:

Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks

Treatment:

Dietary Supplement: L-carnitine

Sugar pill

Placebo Comparator group

Description:

Oral administration of placebo sugar pill

Treatment:

Dietary Supplement: Placebo