Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals

NCT ID: NCT05163964

Last Updated: 2024-05-08

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

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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PreDiabetes Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

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

Lifestyle Intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Dietary consultation

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Malaysia

OTHER

Sponsor Role collaborator

Universiti Tunku Abdul Rahman

OTHER

Sponsor Role lead

Responsible Party

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Koo Hui Chin

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Community Clinic Sungai Udang

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Ayer Keroh

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Ayer Molek

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Bukit Rambai

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Jalan Gereja

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Klebang Besar

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Seri Tanjung

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Tengkera

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Ujong Pasir

Melaka Tengah, Melaka, Malaysia

Site Status

Community Clinic Peringgit

Malacca, , Malaysia

Site Status

Community Clinic Batu Berendam

Malacca, , Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 34444846 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30510391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32761356 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 26598903 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28143856 (View on PubMed)

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 diabetes: The KAMOGAWA-DM cohort study. Endocr J. 2018 Apr 26;65(4):395-402. doi: 10.1507/endocrj.EJ17-0414. Epub 2018 Jan 27.

Reference Type RESULT
PMID: 29375081 (View on PubMed)

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. 2017 Jul;129:206-212. doi: 10.1016/j.diabres.2017.05.010. Epub 2017 May 16.

Reference Type RESULT
PMID: 28549298 (View on PubMed)

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.

Reference Type RESULT
PMID: 30410377 (View on PubMed)

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 2017 Jan 27.

Reference Type RESULT
PMID: 28128995 (View on PubMed)

Chong GY, Kaur S, Abd Talib R, Loy SL, Tan HY, Binti Abdullah R, Binti Mahmud H, Siah WY, Tan LK, Kee CC, Koo HC. Association between chrononutrition, sleep behaviours, and glycaemic outcomes in individuals with prediabetes: Findings from the Chrono-DMTM study. Chronobiol Int. 2025 Oct;42(10):1328-1340. doi: 10.1080/07420528.2025.2543298. Epub 2025 Aug 20.

Reference Type DERIVED
PMID: 40832725 (View on PubMed)

Chong GY, Kaur S, Talib RA, Loy SL, Tan HY, Harjit Singh SS, Abdullah RB, Mahmud HB, Siah WY, Koo HC. Chronotype, chrononutrition and glucose tolerance among prediabetic individuals: research protocol for a prospective longitudinal study Chrono-DM. BMC Prim Care. 2022 Aug 4;23(1):193. doi: 10.1186/s12875-022-01815-7.

Reference Type DERIVED
PMID: 35922777 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://nutrition.bmj.com/content/early/2019/01/08/bmjnph-2018-000011

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.

Other Identifiers

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TAR UC/EC/2021/02-3

Identifier Type: -

Identifier Source: org_study_id

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