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NCT Number: NCT05163964

Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Community Clinic Ayer Keroh, Melaka Tengah, Melaka, Malaysia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Lifestyle Intervention

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.

Other names: Dietary consultation

Primary outcomes

  1. The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.

    Time frame: Baseline to 6 months

    The results displayed in unit (%)

  2. 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).

  3. 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).

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Universiti Tunku Abdul Rahman

Other

Collaborators

  • National University of Malaysia

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 20, 2021
Registry last updated
May 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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