NCT02197299

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

December 3, 2015

Status Verified

December 1, 2015

Enrollment Period

1.9 years

First QC Date

July 18, 2014

Last Update Submit

December 1, 2015

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Skeletal muscle total carnitine content

    up to 24 weeks of L-carnitine supplementation

Study Arms (2)

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

L-carnitineDIETARY_SUPPLEMENT
Carnitine
PlaceboDIETARY_SUPPLEMENT
Sugar pill

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nottingham, NG72UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic Chemicals

Study Officials

  • Francis B Stephens, PhD

    The University of Nottingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis B Stephens, PhD

CONTACT

00441158230398francis.stephens@nottingham.ac.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2014

First Posted

July 22, 2014

Study Start

August 1, 2014

Primary Completion

July 1, 2016

Last Updated

December 3, 2015

Record last verified: 2015-12

Locations

GB(1)