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Improving Glycaemic Control With L-carnitine

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02197299
Enrollment
24
Registered
2014-07-22
Start date
2014-08-31
Completion date
Unknown
Last updated
2015-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

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.

Interventions

DIETARY_SUPPLEMENTL-carnitine
DIETARY_SUPPLEMENTPlacebo

Sponsors

University of Nottingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Skeletal muscle total carnitine contentup to 24 weeks of L-carnitine supplementation

Countries

United Kingdom

Contacts

Primary ContactFrancis B Stephens, PhD
francis.stephens@nottingham.ac.uk00441158230398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026