Improving Glycaemic Control With L-carnitine

Phase 2

• Conditions: Type 2 Diabetes
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: L-carnitine

• Registration Number: NCT02197299
• Lead Sponsor: University of Nottingham

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-18
• Study First Posted: 2014-07-22
• Study Start: 2014-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar pill	Placebo	Oral administration of placebo sugar pill
Carnitine	L-carnitine	Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks

Primary Outcome Measures

Name	Time	Method
Skeletal muscle total carnitine content	up to 24 weeks of L-carnitine supplementation

Trial Locations

Locations (1)

David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham; 🇬🇧 Nottingham, United Kingdom