Improving Glycaemic Control With L-carnitine

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02197299
• Other study ID #: 14/EM/0136
• Secondary ID: 13/0004659
• Status: Recruiting
• Phase: Phase 2
• First received: July 18, 2014
• Last updated: December 1, 2015
• Start date: August 2014

Study information

• Verified date: December 2015
• Source: University of Nottingham
• Contact: Francis B Stephens, PhD
• Phone: 00441158230398
• Email: francis.stephens[@]nottingham.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Dietary Supplement:
• L-carnitine

• Placebo

Locations

Country	Name	City	State
United Kingdom	David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skeletal muscle total carnitine content		up to 24 weeks of L-carnitine supplementation	No