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临床试验/NCT04446754
NCT04446754已完成不适用

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

St Mary's University College1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2019年4月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
73
试验地点
1
主要终点
Hba1c

研究概览

简要总结

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).

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hba1c

时间窗: 3 months

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

Diet intake

时间窗: 3 months

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

DNA

时间窗: 3 months

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

次要结局

  • Body weight(3 months)
  • Height(3 months)
  • Lean mass(3 months)
  • Physical activity(3 months)
  • Fat mass(3 months)
  • Waist(3 months)
  • Hip(3 months)

研究者

发起方
St Mary's University College
申办方类型
Other
责任方
Sponsor

研究点 (1)

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