<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/NCT04446754</url>
  </required_header>
  <id_info>
    <org_study_id>SMEC_2018-19_034</org_study_id>
    <nct_id>NCT04446754</nct_id>
  </id_info>
  <brief_title>The Genetic Effects of rs7903146 and Dietary Intake on Type 2 Diabetes Mellitus Risk in a Healthy Population</brief_title>
  <official_title>The Association Between TCF7L2 rs7903146, Diet and Type 2 Diabetes Mellitus Risk</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St Mary's University College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>StMarysUC</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the association of genetic effects of rs7903146 and dietary intake on&#xD;
      type 2 Diabetes Mellitus (T2DM) risk in a healthy population. T2DM risk was assessed through&#xD;
      glycated haemoglobin (HbA1c) concentration in 73 subjects. Dietary intake was assessed using&#xD;
      a validated food frequency questionnaire (FFQ).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Type 2 diabetes mellitus (T2DM) is a global epidemic linked to 1.6 million deaths in 2016.&#xD;
      Diet, lifestyle and environment contribute significantly to T2DM-risk. Genome-wide&#xD;
      association studies identify the transcription factor 7-like 2 (TCF7L2) rs7903146 (C/T) gene&#xD;
      as one of the most important associated with T2DM-risk. The T-allele is associated with a&#xD;
      two-fold increase in relative risk of T2DM across different populations. However, most&#xD;
      studies associating genetic effects of dietary intake on rs7903146 and T2DM-risk utilised&#xD;
      volatile instantaneous measures of glucose(5) and focussed on individual macronutrients.&#xD;
      Understanding the association of rs7903146 and overall macronutrient intake using a stable&#xD;
      blood homeostasis marker may provide a fuller insight into T2DM-risk.&#xD;
&#xD;
      The study included data for all variables (participant characteristics: sex (female/male),&#xD;
      age (years), height (cm), weight (kg), body mass index (BMI) (kg/m2), body fat percentage&#xD;
      (%), fat mass (kg), lean mass (kg), waist/hip (ratio), dietary intake, HbA1c (mmol/mol and %)&#xD;
      and physical activity (hours/week). All data was collected at St Mary's University between&#xD;
      April to July 2019. Participants was genotyped and allocated into two groups: major allele&#xD;
      (C) homozygote versus minor allele (T) homozygote plus heterozygote. T2DM-risk was assessed&#xD;
      through their value of HbA1c and participants were classified as follows: normal&#xD;
      (&lt;42mmol/mol/ &lt;6.0%), pre-diabetic (42 to 47 mmol/mol/ 6.0% to 6.4%), diabetes (48mmol/mol&#xD;
      /6.5% or over).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2019</start_date>
  <completion_date type="Actual">October 2, 2019</completion_date>
  <primary_completion_date type="Actual">September 20, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>DNA</measure>
    <time_frame>3 months</time_frame>
    <description>salivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hba1c</measure>
    <time_frame>3 months</time_frame>
    <description>capillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG &amp; C0., Nümbrecht, Germany)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diet intake</measure>
    <time_frame>3 months</time_frame>
    <description>Dietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>3 months</time_frame>
    <description>Body weight in kg measured by bioelectrical impedance analysis using a 0.5kg clothing offset</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Waist</measure>
    <time_frame>3 months</time_frame>
    <description>Waist measurement was taken midway between iliac crest and lowest rib</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hip</measure>
    <time_frame>3 months</time_frame>
    <description>Hip circumference was measured over the greater trochanters at their widest point (nearest 0.1cm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Height</measure>
    <time_frame>3 months</time_frame>
    <description>Subject height was recorded to the nearest 0.1-cm via stadiometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical activity</measure>
    <time_frame>3 months</time_frame>
    <description>Assessed through Physical Activity Readiness Questionnaire (PAR-Q)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fat mass</measure>
    <time_frame>3 months</time_frame>
    <description>Measured in kg and percentage (%) measured by bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lean mass</measure>
    <time_frame>3 months</time_frame>
    <description>Measured in kg and percentage (%) measured by bioelectrical impedance analysis</description>
  </secondary_outcome>
  <enrollment type="Actual">73</enrollment>
  <condition>Health Behavior</condition>
  <condition>Blood Glucose, High</condition>
  <condition>Diet Habit</condition>
  <condition>Genetic Predisposition</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Saliva and blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Male-female age between 18 to 64.9 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria: Eligibility criteria required healthy adults free from metabolic&#xD;
        condition and free from medication affecting glycated haemoglobin levels.&#xD;
&#xD;
        Exclusion criteria: Individuals with HbA1c levels ≥48 mmol/mol or ≥6.5% were excluded due&#xD;
        to a classification as T2DM (WHO, 2011).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>St Marys University</name>
      <address>
        <city>London</city>
        <zip>TW1 4SX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</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</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
    <mesh_term>Genetic Predisposition to Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04446754
org study id: SMEC_2018-19_034
nct id: NCT04446754
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study investigates the association of genetic effects of rs7903146 and dietary intake on
      type 2 Diabetes Mellitus (T2DM) risk in a healthy population. T2DM risk was assessed through
      glycated haemoglobin (HbA1c) concentration in 73 subjects. Dietary intake was assessed using
      a validated food frequency questionnaire (FFQ).
Type 2 diabetes mellitus (T2DM) is a global epidemic linked to 1.6 million deaths in 2016.
      Diet, lifestyle and environment contribute significantly to T2DM-risk. Genome-wide
      association studies identify the transcription factor 7-like 2 (TCF7L2) rs7903146 (C/T) gene
      as one of the most important associated with T2DM-risk. The T-allele is associated with a
      two-fold increase in relative risk of T2DM across different populations. However, most
      studies associating genetic effects of dietary intake on rs7903146 and T2DM-risk utilised
      volatile instantaneous measures of glucose(5) and focussed on individual macronutrients.
      Understanding the association of rs7903146 and overall macronutrient intake using a stable
      blood homeostasis marker may provide a fuller insight into T2DM-risk.

      The study included data for all variables (participant characteristics: sex (female/male),
      age (years), height (cm), weight (kg), body mass index (BMI) (kg/m2), body fat percentage
      (%), fat mass (kg), lean mass (kg), waist/hip (ratio), dietary intake, HbA1c (mmol/mol and %)
      and physical activity (hours/week). All data was collected at St Mary's University between
      April to July 2019. Participants was genotyped and allocated into two groups: major allele
      (C) homozygote versus minor allele (T) homozygote plus heterozygote. T2DM-risk was assessed
      through their value of HbA1c and participants were classified as follows: normal
      (<42mmol/mol/ <6.0%), pre-diabetic (42 to 47 mmol/mol/ 6.0% to 6.4%), diabetes (48mmol/mol
      /6.5% or over).
observational model: Cohort
time perspective: Cross-Sectional
measure: DNA
time frame: 3 months
description: salivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)
measure: Hba1c
time frame: 3 months
description: capillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG & C0., Nümbrecht, Germany)
measure: Diet intake
time frame: 3 months
description: Dietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)
measure: Body weight
time frame: 3 months
description: Body weight in kg measured by bioelectrical impedance analysis using a 0.5kg clothing offset
measure: Waist
time frame: 3 months
description: Waist measurement was taken midway between iliac crest and lowest rib
measure: Hip
time frame: 3 months
description: Hip circumference was measured over the greater trochanters at their widest point (nearest 0.1cm)
measure: Height
time frame: 3 months
description: Subject height was recorded to the nearest 0.1-cm via stadiometer
measure: Physical activity
time frame: 3 months
description: Assessed through Physical Activity Readiness Questionnaire (PAR-Q)
measure: Fat mass
time frame: 3 months
description: Measured in kg and percentage (%) measured by bioelectrical impedance analysis
measure: Lean mass
time frame: 3 months
description: Measured in kg and percentage (%) measured by bioelectrical impedance analysis
Saliva and blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 64 Years
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2
mesh term: Genetic Predisposition to Disease
sharing ipd: No