Improving Glycaemic Control With L-carnitine | NCT02197299

Studies
Improving Glycaemic Control With L-carnitine

NCT02197299

Sponsor

University of Nottingham

Status

Unknown status

Last Update Posted

Dec 3, 2015Estimated

Enrollment

24Estimated

Phase

Phase 2

Conditions

Type 2 Diabetes

Interventions

L-carnitine
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
13/0004659	Other Grant/Funding Number	Diabetes UK

Status Module

Record Verification Date

Dec 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Jul 2016Estimated

Completion Date

Not provided

First Submitted Date

Jul 18, 2014

First Submission Date that Met QC Criteria

Jul 18, 2014

First Posted Date

Jul 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2015

Last Update Posted Date

Dec 3, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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	Dietary Supplement: L-carnitine
Sugar pill	Placebo Comparator	Oral administration of placebo sugar pill	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
L-carnitine	Dietary Supplement		Carnitine
Placebo

Measure	Description	Time Frame
Skeletal muscle total carnitine content		up to 24 weeks of L-carnitine supplementation

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francis B Stephens, PhD	Contact	00441158230398		francis.stephens@nottingham.ac.uk

Overall Officials

Name	Affiliation	Role
Francis B Stephens, PhD	The University of Nottingham	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham	Recruiting	Nottingham		NG72UH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002331	Carnitine

Ancestor Terms

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided