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

Health Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04446754
• Other study ID #: SMEC_2018-19_034
• Status: Completed
• Start date: April 10, 2019
• Est. completion date: October 2, 2019

Study information

• Verified date: June 2020
• Source: St Mary's University College
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: October 2, 2019
• Est. primary completion date: September 20, 2019
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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).

Related Conditions & MeSH terms

• Blood Glucose, High
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diet Habit
• Disease Susceptibility
• Genetic Predisposition
• Genetic Predisposition to Disease
• Health Behavior
• Hyperglycemia

Locations

Country	Name	City	State
United Kingdom	St Marys University	London

Sponsors (1)

Lead Sponsor	Collaborator
St Mary's University College

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA	salivary (1-ml) DNA for genotype TCF7L2 gene (rs7903146 SNP)	3 months
Primary	Hba1c	capillary blood collected (via the ears or fingers) using a Microvette CB Lithium Heparin tube (SARSTEDT AG & C0., Nümbrecht, Germany)	3 months
Primary	Diet intake	Dietary intake estimated using The European Prospective Investigation into Cancer and Nutrition (EPIC)-Norfolk (food frequency questionnaire)	3 months
Secondary	Body weight	Body weight in kg measured by bioelectrical impedance analysis using a 0.5kg clothing offset	3 months
Secondary	Waist	Waist measurement was taken midway between iliac crest and lowest rib	3 months
Secondary	Hip	Hip circumference was measured over the greater trochanters at their widest point (nearest 0.1cm)	3 months
Secondary	Height	Subject height was recorded to the nearest 0.1-cm via stadiometer	3 months
Secondary	Physical activity	Assessed through Physical Activity Readiness Questionnaire (PAR-Q)	3 months
Secondary	Fat mass	Measured in kg and percentage (%) measured by bioelectrical impedance analysis	3 months
Secondary	Lean mass	Measured in kg and percentage (%) measured by bioelectrical impedance analysis	3 months