Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals: Chrono-DM TM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- The change of baseline 2-hour post-load plasma glucose among prediabetes adults at 6 months.
研究概览
简要总结
Chronotype and chrononutrition, both are emerging research fields in nutritional epidemiology. However, its association with glycemic control in the global population is less clear. A better understanding of how activity/ eating time can influence glucose levels in prediabetic individuals may improve strategies for blood glucose control. The present paper aims to determine the associations of chronotype and chrononutrition with glucose tolerance among prediabetic individuals in Malaysia.
详细描述
This is a prospective longitudinal study named Chrono-DMTM, that targets to recruit 166 newly diagnosed prediabetic individuals from the community clinics in Malacca, Malaysia. Respondents will be followed-up for 6 months: (1) baseline (1st oral glucose tolerance test (OGTT)); (2) second visit (at 3rd month); and (3) third visit (2nd OGTT at 6th month). Data collection includes sociodemographic and anthropometry measurements (weight, height, body fat, visceral fat, waist and hip circumference). Dietary intake and meal timing are collected using the 3-day dietary record while data on sleep pattern, light exposure, chronotype and chrononutrition will be collected using validated questionnaires. Physical activity will be captured using a validated IPAQ questionnaire and pedometer during periods of wearing Continuous glucose monitoring (CGM) sensor. CGM, fasting plasma glucose (FBG), OGTT and HbA1c are performed to assess glycemic outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newly diagnosed prediabetic individuals who have been first seen by clinical dieticians registered under the Ministry of Health Malaysia.
- •Malaysian ≥ 18 years old.
- •Those who plan to continue prediabetes care at the selected community clinic in Melaka.
- •Those who can read, write and understand the Malay Language.
排除标准
- •Night shift workers at least 3 times per week.
- •Known sleep disorder.
- •Pregnant Women.
- •Those on oral glucose-lowering medications, diabetes supplements, anticonvulsant medications or oral steroids currently or in the last month.
- •Those with prior explored to any information regarding time-of-eating/time-of-activity restriction.
- •Those with chronic kidney disease. They are excluded as current research lack of evidence to support the accuracy of using 24-hour continuous glucose monitoring system (CGMS) (Freestyle Libre Pro, Abbott, Germany).
结局指标
主要结局
The change of baseline 2-hour post-load plasma glucose among prediabetes adults at 6 months.
时间窗: Baseline to 6 months
The results displayed in unit (mmol/L).
The change of baseline fasting plasma glucose (FPG) among prediabetes adults at 6 months.
时间窗: Baseline to 6 months
The results displayed in unit (mmol/L).
The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.
时间窗: Baseline to 6 months
The results displayed in unit (%)
The change of baseline continuous glucose monitoring (CGM) profile among prediabetes adults at 6 months.
时间窗: Baseline to 6 months
The results displayed in glycemic variability.
次要结局
- The change of eating misalignment among prediabetes adults at 6 months(Baseline to 6 months)
- The change of chronotype among prediabetes adults at 6 months.(Baseline to 6 months)
研究者
Koo Hui Chin
Associate Professor
Universiti Tunku Abdul Rahman