Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals

Completed

• Conditions: PreDiabetes; Diabetes Mellitus, Type 2
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT05163964
• Lead Sponsor: Universiti Tunku Abdul Rahman

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-11-08
• Study First Submitted QC: 2021-12-04
• Study First Posted: 2021-12-20
• Study Start: 2022-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Newly diagnosed prediabetic individuals who have been first seen by clinical dieticians registered under the Ministry of Health Malaysia.
2. Malaysian ≥ 18 years old.
3. Those who plan to continue prediabetes care at the selected community clinic in Melaka.
4. Those who can read, write and understand the Malay Language.

Exclusion Criteria

1. Night shift workers at least 3 times per week.
2. Known sleep disorder.
3. Pregnant Women.
4. Those on oral glucose-lowering medications, diabetes supplements, anticonvulsant medications or oral steroids currently or in the last month.
5. Those with prior explored to any information regarding time-of-eating/time-of-activity restriction.
6. 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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	Lifestyle Intervention	Prediabetes patients aged 18-65 years old, who plan to continue healthcare services at a community clinic in Malacca, no literacy barries

Primary Outcome Measures

Name	Time	Method
The change of baseline 2-hour post-load plasma glucose among prediabetes adults at 6 months.	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.	Baseline to 6 months	The results displayed in unit (mmol/L).
The change of baseline continuous glucose monitoring (CGM) profile among prediabetes adults at 6 months.	Baseline to 6 months	The results displayed in glycemic variability.
The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.	Baseline to 6 months	The results displayed in unit (%)

Secondary Outcome Measures

Name	Time	Method
The change of eating misalignment among prediabetes adults at 6 months	Baseline to 6 months	By using the validated questionnaire Chrononutrition Profile Questionnaire (CPQ), the six different chrononutrition behaviors, which are breakfast skipping, largest meal, evening eating, evening latency, night eating, and eating window can be collected.; The CP-Q is used to evaluate eating misalignment. Eating misalignment is discrepancies between when people prefer to eat and when participants actually eat. Discrepancies can be calculated by using the chrononutrition behavior values for the item of interest. These are then subtracted from the preference value as measured by the CP-Q.
The change of chronotype among prediabetes adults at 6 months.	Baseline to 6 months	By using the validated questionnaire Munich Chronotype Questionnaire (MCTQ), participants will be categorized into morning type, evening type, and neither type for the chronotype category data.

Trial Locations

Locations (11)

Community Clinic Sungai Udang; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Batu Berendam; 🇲🇾 Melaka, Malaysia

Community Clinic Klebang Besar; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Tengkera; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Ayer Molek; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Bukit Rambai; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Seri Tanjung; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Ayer Keroh; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Jalan Gereja; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Ujong Pasir; 🇲🇾 Melaka Tengah, Melaka, Malaysia

Community Clinic Peringgit; 🇲🇾 Melaka, Malaysia