Contact information
Type
Scientific
Primary contact
Dr Francis Stephens
ORCID ID
Contact details
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
+44 115 823 0398
francis.stephens@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16883
Study information
Scientific title
Increasing skeletal muscle carnitine content to improve glycaemic control in type 2 diabetes mellitus
Acronym
Study hypothesis
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
14/04/2014, ref: 14/EM/0136
Study design
Randomised; Interventional; Design type: Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase II
Drug names
Primary outcome measures
Skeletal muscle total carnitine content is measured at baseline and 24 weeks.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2014
Overall trial end date
31/07/2016
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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
Participant 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.
Recruitment start date
01/08/2014
Recruitment end date
31/07/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Funders
Funder type
Charity
Funder name
Diabetes UK
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary