Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
24 participants
INTERVENTIONAL
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
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Carnitine
Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks
L-carnitine
Sugar pill
Oral administration of placebo sugar pill
Placebo
Interventions
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L-carnitine
Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
MALE
No
Sponsors
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University of Nottingham
OTHER
Responsible Party
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Principal Investigators
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Francis B Stephens, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Nottingham
Locations
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David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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13/0004659
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
14/EM/0136
Identifier Type: -
Identifier Source: org_study_id