The Genetic Effects of rs7903146 and Dietary Intake on Type 2 Diabetes Mellitus Risk in a Healthy Population

Sponsor
St Mary's University College (Other)
Overall Status
Completed
CT.gov ID
NCT04446754
Collaborator
(none)
73
1
5.7
12.7

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    73 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Association Between TCF7L2 rs7903146, Diet and Type 2 Diabetes Mellitus Risk
    Actual Study Start Date :
    Apr 10, 2019
    Actual Primary Completion Date :
    Sep 20, 2019
    Actual Study Completion Date :
    Oct 2, 2019

    Outcome Measures

    Primary Outcome Measures

    1. DNA [3 months]

      salivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)

    2. Hba1c [3 months]

      capillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG & C0., Nümbrecht, Germany)

    3. Diet intake [3 months]

      Dietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)

    Secondary Outcome Measures

    1. Body weight [3 months]

      Body weight in kg measured by bioelectrical impedance analysis using a 0.5kg clothing offset

    2. Waist [3 months]

      Waist measurement was taken midway between iliac crest and lowest rib

    3. Hip [3 months]

      Hip circumference was measured over the greater trochanters at their widest point (nearest 0.1cm)

    4. Height [3 months]

      Subject height was recorded to the nearest 0.1-cm via stadiometer

    5. Physical activity [3 months]

      Assessed through Physical Activity Readiness Questionnaire (PAR-Q)

    6. Fat mass [3 months]

      Measured in kg and percentage (%) measured by bioelectrical impedance analysis

    7. Lean mass [3 months]

      Measured in kg and percentage (%) measured by bioelectrical impedance analysis

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All

    Inclusion criteria: Eligibility criteria required healthy adults free from metabolic condition and free from medication affecting glycated haemoglobin levels.

    Exclusion criteria: Individuals with HbA1c levels ≥48 mmol/mol or ≥6.5% were excluded due to a classification as T2DM (WHO, 2011).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Marys University London United Kingdom TW1 4SX

    Sponsors and Collaborators

    • St Mary's University College

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    St Mary's University College
    ClinicalTrials.gov Identifier:
    NCT04446754
    Other Study ID Numbers:
    • SMEC_2018-19_034
    First Posted:
    Jun 25, 2020
    Last Update Posted:
    Jun 25, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 25, 2020