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

NCT ID: NCT04446754

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-10

Study Completion Date

2019-10-02

Brief Summary

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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

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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).

Conditions

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Health Behavior Blood Glucose, High Diet Habit Genetic Predisposition

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St Mary's University College

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Marys University

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Podboi ICR, Stephenson S, Pilic L, Graham CA, King A, Mavrommatis Y. Dietary Intake and TCF7L2 rs7903146 T Allele Are Associated with Elevated Blood Glucose Levels in Healthy Individuals. Lifestyle Genom. 2021;14(4):117-123. doi: 10.1159/000518523. Epub 2021 Aug 12.

Reference Type DERIVED
PMID: 34515148 (View on PubMed)

Other Identifiers

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SMEC_2018-19_034

Identifier Type: -

Identifier Source: org_study_id

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