<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02197299</url>
  </required_header>
  <id_info>
    <org_study_id>14/EM/0136</org_study_id>
    <secondary_id>13/0004659</secondary_id>
    <nct_id>NCT02197299</nct_id>
  </id_info>
  <brief_title>Improving Glycaemic Control With L-carnitine</brief_title>
  <official_title>Increasing Skeletal Muscle Carnitine Content to Improve Glycaemic Control in Type 2 Diabetes Mellitus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nottingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nottingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A characteristic of Type 2 diabetes is a high blood glucose level, which is partly caused by&#xD;
      the inability of insulin to stimulate glucose uptake into our muscles (insulin resistance).&#xD;
      Insulin resistance can be caused by the accumulation of fat within muscle of overweight&#xD;
      individuals. The aim of the present research is to test whether a novel nutritional&#xD;
      intervention containing L-carnitine can increase the amount of carnitine within muscle of&#xD;
      individuals recently diagnosed with Type 2 diabetes. Carnitine is essential for 'burning fat'&#xD;
      within our muscles and it is hoped that increasing the amount of carnitine within muscle can&#xD;
      increase fat burning, lower muscle fat, reverse insulin resistance and ultimately lower blood&#xD;
      glucose levels and wellbeing. We also aim to investigate the cellular mechanisms underlying&#xD;
      any observed effects in a hope to identify further targets to lower muscle fat.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">July 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Skeletal muscle total carnitine content</measure>
    <time_frame>up to 24 weeks of L-carnitine supplementation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Carnitine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Oral administration of placebo sugar pill</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>L-carnitine</intervention_name>
    <arm_group_label>Carnitine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Sugar pill</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body mass index (BMI) 27-37 kg/m2&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age 18-60 years old&#xD;
&#xD;
          -  Type 2 diabetes mellitus reasonably well controlled (HbA1c less than or equal to 58&#xD;
             mmol/mol) on diet therapy or metformin alone&#xD;
&#xD;
          -  Not taking anti-diabetes medication other than metformin&#xD;
&#xD;
          -  Understand verbal and/or written explanation of the study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Malignancy (excluding localised basal and squamous cell skin cancer)&#xD;
&#xD;
          -  Metabolic diseases (stable treated hypothyroidism allowed)&#xD;
&#xD;
          -  Active cardiovascular disease (current angina, myocardial infarct, or coronary artery&#xD;
             surgery/angioplasty within 12 months)&#xD;
&#xD;
          -  Primary muscle disorders&#xD;
&#xD;
          -  Cerebrovascular disease&#xD;
&#xD;
          -  Neurological disease e.g. epilepsy, Parkinsons disease&#xD;
&#xD;
          -  Active respiratory disease&#xD;
&#xD;
          -  Active gastrointestinal or liver disease&#xD;
&#xD;
          -  Renal impairment (eGFR &lt;60 ml/min)&#xD;
&#xD;
          -  Clotting dysfunction&#xD;
&#xD;
          -  Anti-diabetes medication other than metformin&#xD;
&#xD;
          -  Other medications that may affect glucose tolerance (e.g. corticosteroids), muscle&#xD;
             metabolism, or safety (e.g. anticoagulants)&#xD;
&#xD;
          -  Any other conditions in addition to the above that the investigators consider may&#xD;
             affect study measurements or safety&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francis B Stephens, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Nottingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Francis B Stephens, PhD</last_name>
    <phone>00441158230398</phone>
    <email>francis.stephens@nottingham.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>David Greenfield Human Physiology Unit, School of Life Sciences, The University of Nottingham</name>
      <address>
        <city>Nottingham</city>
        <zip>NG72UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara Brown</last_name>
      <email>sara.brown@nottingham.ac.uk</email>
    </contact>
    <investigator>
      <last_name>Francis B Stephens, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>December 1, 2015</last_update_submitted>
  <last_update_submitted_qc>December 1, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02197299
org study id: 14/EM/0136
secondary id: 13/0004659
nct id: NCT02197299
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Double (Participant, Investigator)
measure: Skeletal muscle total carnitine content
time frame: up to 24 weeks of L-carnitine supplementation
arm group label: Carnitine
arm group type: Experimental
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 group label: Sugar pill
arm group type: Placebo Comparator
description: Oral administration of placebo sugar pill
intervention type: Dietary Supplement
intervention name: L-carnitine
arm group label: Carnitine
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Sugar pill
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Francis B Stephens, PhD
role: Principal Investigator
affiliation: The University of Nottingham
last name: Francis B Stephens, PhD
phone: 00441158230398
email: francis.stephens@nottingham.ac.uk
facility: 
status: Recruiting
contact: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 2