Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals: Chrono-DM TM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05163964
• Other study ID #: TAR UC/EC/2021/02-3
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Universiti Tunku Abdul Rahman
• Contact: Hui Chin Koo, PhD
• Phone: +6012-434 1151
• Email: koohc[@]tarc.edu.my
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 166
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• PreDiabetes

Intervention

Behavioral:
• Lifestyle Intervention
Circadian misalignment contributes to the high glycemic outcome. To adjust meal timing earlier and avoid late-night meal eating patterns, to switch from the evening chronotype to morning chronotype possibility to reverse glucose fluctuation conditions.

Locations

Country	Name	City	State
Malaysia	Community Clinic Batu Berendam	Melaka
Malaysia	Community Clinic Peringgit	Melaka
Malaysia	Community Clinic Ayer Keroh	Melaka Tengah	Melaka
Malaysia	Community Clinic Ayer Molek	Melaka Tengah	Melaka
Malaysia	Community Clinic Bukit Rambai	Melaka Tengah	Melaka
Malaysia	Community Clinic Jalan Gereja	Melaka Tengah	Melaka
Malaysia	Community Clinic Klebang Besar	Melaka Tengah	Melaka
Malaysia	Community Clinic Seri Tanjung	Melaka Tengah	Melaka
Malaysia	Community Clinic Sungai Udang	Melaka Tengah	Melaka
Malaysia	Community Clinic Tengkera	Melaka Tengah	Melaka
Malaysia	Community Clinic Ujong Pasir	Melaka Tengah	Melaka

Sponsors (2)

Lead Sponsor	Collaborator
Universiti Tunku Abdul Rahman	National University of Malaysia

Country where clinical trial is conducted

Malaysia, 

References & Publications (9)

Anothaisintawee T, Lertrattananon D, Thamakaison S, Knutson KL, Thakkinstian A, Reutrakul S. Later chronotype is associated with higher hemoglobin A1c in prediabetes patients. Chronobiol Int. 2017;34(3):393-402. doi: 10.1080/07420528.2017.1279624. Epub 20 — View Citation

Gouda M, Matsukawa M, Iijima H. Associations between eating habits and glycemic control and obesity in Japanese workers with type 2 diabetes mellitus. Diabetes Metab Syndr Obes. 2018 Oct 17;11:647-658. doi: 10.2147/DMSO.S176749. eCollection 2018. — View Citation

Hawley JA, Sassone-Corsi P, Zierath JR. Chrono-nutrition for the prevention and treatment of obesity and type 2 diabetes: from mice to men. Diabetologia. 2020 Nov;63(11):2253-2259. doi: 10.1007/s00125-020-05238-w. Epub 2020 Aug 6. — View Citation

Imai S, Kajiyama S, Hashimoto Y, Yamane C, Miyawaki T, Ozasa N, Tanaka M, Fukui M. Divided consumption of late-night-dinner improves glycemic excursions in patients with type 2 diabetes: A randomized cross-over clinical trial. Diabetes Res Clin Pract. 201 — View Citation

Jiang P, Turek FW. Timing of meals: when is as critical as what and how much. Am J Physiol Endocrinol Metab. 2017 May 1;312(5):E369-E380. doi: 10.1152/ajpendo.00295.2016. Epub 2017 Jan 31. — View Citation

Mezitis NHE, Bhatnagar V. Chrononutrition Applied to Diabetes Management: A Paradigm Shift Long Delayed. Diabetes Spectr. 2018 Nov;31(4):349-353. doi: 10.2337/ds18-0014. No abstract available. — View Citation

Oda H. Chrononutrition. J Nutr Sci Vitaminol (Tokyo). 2015;61 Suppl:S92-4. doi: 10.3177/jnsv.61.S92. — View Citation

Sakai R, Hashimoto Y, Ushigome E, Miki A, Okamura T, Matsugasumi M, Fukuda T, Majima S, Matsumoto S, Senmaru T, Hamaguchi M, Tanaka M, Asano M, Yamazaki M, Oda Y, Fukui M. Late-night-dinner is associated with poor glycemic control in people with type 2 di — View Citation

Wirth MD, Zhao L, Turner-McGrievy GM, Ortaglia A. Associations between Fasting Duration, Timing of First and Last Meal, and Cardiometabolic Endpoints in the National Health and Nutrition Examination Survey. Nutrients. 2021 Aug 3;13(8):2686. doi: 10.3390/nu13082686. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.	The results displayed in unit (%)	Baseline to 6 months
Primary	The change of baseline fasting plasma glucose (FPG) among prediabetes adults at 6 months.	The results displayed in unit (mmol/L).	Baseline to 6 months
Primary	The change of baseline 2-hour post-load plasma glucose among prediabetes adults at 6 months.	The results displayed in unit (mmol/L).	Baseline to 6 months
Primary	The change of baseline continuous glucose monitoring (CGM) profile among prediabetes adults at 6 months.	The results displayed in glycemic variability.	Baseline to 6 months
Secondary	The change of eating misalignment among prediabetes adults at 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.	Baseline to 6 months
Secondary	The change of chronotype among prediabetes adults at 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.	Baseline to 6 months

External Links

•   Effect of a 2-hour interval between dinner and bedtime on glycated haemoglobin levels in middle-aged and elderly Japanese people: a longitudinal analysis of 3-year health check-up data.