Improving glycaemic control with L carnitine

ISRCTN	ISRCTN46349186
DOI	https://doi.org/10.1186/ISRCTN46349186
ClinicalTrials.gov number	NCT02197299
Secondary identifying numbers	16883

Submission date: 25/07/2014
Registration date: 25/07/2014
Last edited: 26/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Francis Stephens
Scientific

Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Phone	+44 115 823 0398
Email	francis.stephens@nottingham.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	GP practice
Study type	Treatment
Scientific title	Increasing skeletal muscle carnitine content to improve glycaemic control in type 2 diabetes mellitus
Study objectives	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.
Ethics approval(s)	14/04/2014, ref: 14/EM/0136
Health condition(s) or problem(s) studied	Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases
Intervention	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
Intervention type	Other
Primary outcome measure	Skeletal muscle total carnitine content is measured at baseline and 24 weeks.
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2014
Completion date	31/07/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	Male
Target number of participants	Planned Sample Size: 36; UK Sample Size: 36; Description: 24 individuals with type 2 diabetes and 12 age and body mass matched controls
Key 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
Key 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.
Date of first enrolment	01/08/2014
Date of final enrolment	31/07/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queen's Medical Centre

Derby Road
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Nottingham University Hospital
University/education

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom

"ROR"	https://ror.org/05y3qh794

Funders

Funder type

Charity

Diabetes UK
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): DIABETES UK LIMITED, British Diabetic Association
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

26/10/2020: The NCT code has been added.
07/03/2016: Verifying study status with principal investigator.