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

Completed

• Conditions: Diet Habit; Genetic Predisposition; Blood Glucose, High; Health Behavior

• Registration Number: NCT04446754
• Lead Sponsor: St Mary's University College

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).

Study Timeline

• Study Start: 2019-04-10
• Primary Completion: 2019-09-20
• Study Completion: 2019-10-02
• Status Verified: 2020-06
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-23
• Last Update Submitted: 2020-06-23
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hba1c	3 months	capillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG \& C0., Nümbrecht, Germany)
Diet intake	3 months	Dietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)
DNA	3 months	salivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)

Secondary Outcome Measures

Name	Time	Method
Body weight	3 months	Body weight in kg measured by bioelectrical impedance analysis using a 0.5kg clothing offset
Height	3 months	Subject height was recorded to the nearest 0.1-cm via stadiometer
Lean mass	3 months	Measured in kg and percentage (%) measured by bioelectrical impedance analysis
Physical activity	3 months	Assessed through Physical Activity Readiness Questionnaire (PAR-Q)
Fat mass	3 months	Measured in kg and percentage (%) measured by bioelectrical impedance analysis
Waist	3 months	Waist measurement was taken midway between iliac crest and lowest rib
Hip	3 months	Hip circumference was measured over the greater trochanters at their widest point (nearest 0.1cm)

Trial Locations

Locations (1)

St Marys University; 🇬🇧 London, United Kingdom