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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

120

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jan 2022

Geographic Reach

1 country

11 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

First Submitted

Initial submission to the registry

November 8, 2021

Completed

1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2021

Completed

12 days until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed

Last Updated

May 8, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

November 8, 2021

Last Update Submit

May 6, 2024

Conditions

PreDiabetes Diabetes Mellitus, Type 2

Keywords

ChrononutritionChronotypeGlycemic outcomesMeal Timing

Outcome Measures

Primary Outcomes (4)

The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.
The results displayed in unit (%)
Baseline to 6 months
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
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
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 Outcomes (2)

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

Study Arms (1)

Control Group

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

Behavioral: Lifestyle Intervention

Interventions

Lifestyle InterventionBEHAVIORAL

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.

Also known as: Dietary consultation

Control Group

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

The proposed study will be conducted in community clinics in Malacca, Malaysia. Malacca is the capital of the coastal stage, located in southwestern Malaysia, with an estimated total population of 0.93 million in the year 2019 (Department of Survey and Mapping Malaysia, 2021). In 2019, National Health and Morbidity Survey reported that 17% of Malaccan adults had hyperglycemia and 13.7% of them had known diabetes. Malacca is 1 out of the top five states showing the highest prevalence of diabetes in Malaysia (IPH, NIH and MOH, 2019). Prediabetes and diabetes will be defined according to the latest Clinical Practice Guideline in Malaysia (WHO \& IDF, 2006; ADA, 2020; MOH et al., 2020).

You may qualify if:

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.

You may not qualify if:

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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Universiti Tunku Abdul Rahmanlead
National University of Malaysiacollaborator

Study Sites (11)

Community Clinic Sungai Udang

Melaka Tengah, Melaka, 75350, Malaysia

Location

Community Clinic Ayer Keroh