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

The Association Between TCF7L2 rs7903146, Diet and Type 2 Diabetes Mellitus Risk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04446754
Enrollment
73
Registered
2020-06-25
Start date
2019-04-10
Completion date
2019-10-02
Last updated
2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Glucose, High, Diet Habit, Genetic Predisposition, Health Behavior

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).

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).

Interventions

None listed

Sponsors

St Mary's University College
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 64 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
Diet intake3 monthsDietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)
DNA3 monthssalivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)
Hba1c3 monthscapillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG & C0., Nümbrecht, Germany)

Secondary

MeasureTime frameDescription
Height3 monthsSubject height was recorded to the nearest 0.1-cm via stadiometer
Physical activity3 monthsAssessed through Physical Activity Readiness Questionnaire (PAR-Q)
Body weight3 monthsBody weight in kg measured by bioelectrical impedance analysis using a 0.5kg clothing offset
Lean mass3 monthsMeasured in kg and percentage (%) measured by bioelectrical impedance analysis
Fat mass3 monthsMeasured in kg and percentage (%) measured by bioelectrical impedance analysis
Waist3 monthsWaist measurement was taken midway between iliac crest and lowest rib
Hip3 monthsHip circumference was measured over the greater trochanters at their widest point (nearest 0.1cm)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026