Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals

May 6, 2024 updated by: Koo Hui Chin, Universiti Tunku Abdul Rahman

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Melaka, Malaysia, 75450
        • Community Clinic Peringgit
      • Melaka, Malaysia, 77000
        • Community Clinic Batu Berendam
    • Melaka
      • Melaka Tengah, Melaka, Malaysia, 75350
        • Community Clinic Sungai Udang
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Ayer Keroh
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Ayer Molek
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Bukit Rambai
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Jalan Gereja
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Klebang Besar
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Seri Tanjung
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Tengkera
      • Melaka Tengah, Melaka, Malaysia, 75450
        • Community Clinic Ujong Pasir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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 Names:
  • Dietary consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.
Time Frame: Baseline to 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.
Time Frame: Baseline to 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.
Time Frame: Baseline to 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.
Time Frame: Baseline to 6 months
The results displayed in glycemic variability.
Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of eating misalignment among prediabetes adults at 6 months
Time Frame: 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.
Baseline to 6 months
The change of chronotype among prediabetes adults at 6 months.
Time Frame: 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.
Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Tunku Abdul Rahman

Collaborators

National University of Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

December 4, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

May 8, 2024

Last Update Submitted That Met QC Criteria

May 6, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAR UC/EC/2021/02-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The validation and reliability of Chrononutrition Profile Questionnaire planned to share with researchers but the other data are not shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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