Condition category
Nutritional, Metabolic, Endocrine
Date applied
25/07/2014
Date assigned
25/07/2014
Last edited
07/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

Nottingham University Hospital

Sponsor details

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

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

07/03/2016: Verifying study status with principal investigator.