Type 2 DiabetesPhase 2NCT02197299
Improving Glycaemic Control With L-carnitine
A Phase 2 study testing L-carnitine in people with Type 2 Diabetes, run by University of Nottingham at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- L-carnitine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Jul 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham
Nottingham, NG72UH
Sara Brown, sara.brown@nottingham.ac.uk
Francis B Stephens, PhD
About this study
Official title: Increasing Skeletal Muscle Carnitine Content to Improve Glycaemic Control in Type 2 Diabetes Mellitus
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.
- Conditions
- Type 2 Diabetes
- Being tested
- L-carnitine, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Carnitine | Experimental | Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks Receives: Dietary Supplement: L-carnitine |
| Sugar pill | Placebo comparator | Oral administration of placebo sugar pill Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle total carnitine content
Measured: up to 24 weeks of L-carnitine supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startAug 2014
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francis B Stephens, PhD, Principal investigator, The University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197299
- Sponsor's protocol ID
- 14/EM/0136
- Other IDs
- 13/0004659
- Status last verified
- Dec 2015
- First submitted
- 18 Jul 2014
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Skeletal Muscle Carnitine Content to Improve Glycaemic Control in Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02197299
- Acronym / sponsor ID
- 14/EM/0136
- Conditions
- Type 2 Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Jul 2016 (estimated)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carnitine | Experimental | Dietary Supplement: L-carnitineOral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks |
| Sugar pill | Placebo comparator | Dietary Supplement: PlaceboOral administration of placebo sugar pill |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitine | Dietary supplement | Carnitine |
| Placebo | Dietary supplement | Sugar pill |
Primary outcome
Skeletal muscle total carnitine content
Time frame: up to 24 weeks of L-carnitine supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francis B Stephens, PhD principal investigator
The University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-carnitine in people with Type 2 Diabetes, run by University of Nottingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francis B Stephens, PhD (00441158230398, francis.stephens@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle total carnitine content (time frame: up to 24 weeks of L-carnitine supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2015.