Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals
NCT ID: NCT05163964
Last Updated: 2024-05-08
Study Results
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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COMPLETED
120 participants
OBSERVATIONAL
2022-01-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
65 Years
ALL
Yes
Sponsors
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National University of Malaysia
OTHER
Universiti Tunku Abdul Rahman
OTHER
Responsible Party
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Koo Hui Chin
Associate Professor
Locations
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Community Clinic Sungai Udang
Melaka Tengah, 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 Tengkera
Melaka Tengah, Melaka, Malaysia
Community Clinic Ujong Pasir
Melaka Tengah, Melaka, Malaysia
Community Clinic Peringgit
Malacca, , Malaysia
Community Clinic Batu Berendam
Malacca, , Malaysia
Countries
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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.
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.
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.
Oda H. Chrononutrition. J Nutr Sci Vitaminol (Tokyo). 2015;61 Suppl:S92-4. doi: 10.3177/jnsv.61.S92.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Related Links
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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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