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Improving Glycaemic Control With L-carnitine

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
L-carnitine
Placebo
Sponsored by
University of Nottingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 60 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • David Greenfield Human Physiology Unit, School of Life Sciences, The University of NottinghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Carnitine

Sugar pill

Arm Description

Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks

Oral administration of placebo sugar pill

Outcomes

Primary Outcome Measures

Skeletal muscle total carnitine content

Secondary Outcome Measures

Full Information

First Posted
July 18, 2014
Last Updated
December 1, 2015
Sponsor
University of Nottingham
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1. Study Identification

Unique Protocol Identification Number
NCT02197299
Brief Title
Improving Glycaemic Control With L-carnitine
Official Title
Increasing Skeletal Muscle Carnitine Content to Improve Glycaemic Control in Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carnitine
Arm Type
Experimental
Arm Description
Oral administration of 4.5 g L-carnitine L-tartrate (containing 3 g L-carnitine; Carnipure, Lonza Ltd., Switzerland) once daily for 24 weeks
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Oral administration of placebo sugar pill
Intervention Type
Dietary Supplement
Intervention Name(s)
L-carnitine
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Skeletal muscle total carnitine content
Time Frame
up to 24 weeks of L-carnitine supplementation

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francis B Stephens, PhD
Phone
00441158230398
Email
francis.stephens@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis B Stephens, PhD
Organizational Affiliation
The University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham
City
Nottingham
ZIP/Postal Code
NG72UH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Brown
Email
sara.brown@nottingham.ac.uk
First Name & Middle Initial & Last Name & Degree
Francis B Stephens, PhD

12. IPD Sharing Statement

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Improving Glycaemic Control With L-carnitine

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