PreDiabetesNCT05163964
Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals
An observational study of PreDiabetes and Diabetes Mellitus, Type 2, run by Universiti Tunku Abdul Rahman at 11 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 11 sitesMalaysia
- Study dates
- 1 Jan 2022to 31 Dec 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Malaysia11 sites
Community Clinic Peringgit
Malacca, 75450
Community Clinic Batu Berendam
Malacca, 77000
Community Clinic Sungai Udang
Melaka Tengah, Melaka, 75350
Community Clinic Ayer Keroh
Melaka Tengah, Melaka, 75450
Community Clinic Ayer Molek
Melaka Tengah, Melaka, 75450
Community Clinic Bukit Rambai
Melaka Tengah, Melaka, 75450
Community Clinic Jalan Gereja
Melaka Tengah, Melaka, 75450
Community Clinic Klebang Besar
Melaka Tengah, Melaka, 75450
Community Clinic Seri Tanjung
Melaka Tengah, Melaka, 75450
Community Clinic Tengkera
Melaka Tengah, Melaka, 75450
Community Clinic Ujong Pasir
Melaka Tengah, Melaka, 75450
About this study
Official title: 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.
Read the 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.
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2
- Being tested
- Lifestyle Intervention
- Keywords
- Chrononutrition, Chronotype, Glycemic outcomes, Meal Timing
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle InterventionBehavioural
Also called Dietary consultation
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Prediabetes patients aged 18-65 years old, who plan to continue healthcare services at a community clinic in Malacca, no literacy barries Receives: Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.
The results displayed in unit (%)
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline to 6 months
Secondary outcomes (2)
The change of eating misalignment among prediabetes adults at 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.
Measured: Baseline to 6 months
The change of chronotype among prediabetes adults at 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universiti Tunku Abdul Rahman
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Malaysia
- Responsible party
- Principal investigator, Koo Hui Chin, Universiti Tunku Abdul Rahman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163964
- Sponsor's protocol ID
- TAR UC/EC/2021/02-3
- Status last verified
- May 2024
- First submitted
- 8 Nov 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The validation and reliability of Chrononutrition Profile Questionnaire planned to share with researchers but the other data are not shared with other researchers.
Publications
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.
PubMed 34444846Mezitis 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.
PubMed 30510391Hawley 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.
PubMed 32761356Oda H. Chrononutrition. J Nutr Sci Vitaminol (Tokyo). 2015;61 Suppl:S92-4. doi: 10.3177/jnsv.61.S92.
PubMed 26598903Jiang 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.
PubMed 28143856Sakai 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.
PubMed 29375081Imai 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.
PubMed 28549298Gouda 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.
PubMed 30410377Anothaisintawee 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.
PubMed 28128995Chong GY, Kaur S, Abd Talib R, Loy SL, Tan HY, Binti Abdullah R, Binti Mahmud H, Siah WY, Kee CC, Koo HC. Exploration of the longitudinal associations between sleep behaviours, anthropometric measurements and body composition in adults with prediabetes. Chronobiol Int. 2026 Jun;43(6):911-923. doi: 10.1080/07420528.2026.2638533. Epub 2026 Mar 11.
PubMed 41810501Chong 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.
PubMed 40832725Chong 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.
PubMed 35922777
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronotype, Chrononutrition and Glucose Tolerance Among Prediabetic Individuals: Chrono-DM TM
- ClinicalTrials.gov ID
- NCT05163964
- Acronym / sponsor ID
- TAR UC/EC/2021/02-3
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2
- Keywords
- Chrononutrition, Chronotype, Glycemic outcomes, Meal Timing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universiti Tunku Abdul RahmanUniversity, hospital or other
- Collaborators
- National University of Malaysia
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control Group | – | Behavioral: Lifestyle InterventionPrediabetes patients aged 18-65 years old, who plan to continue healthcare services at a community clinic in Malacca, no literacy barries |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle InterventionAlso: Dietary consultationCircadian 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. | Behavioural | Control Group |
Primary outcome
The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months.
Time frame: Baseline to 6 months
The results displayed in unit (%)
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).
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).
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.
2 secondary outcomes
The change of eating misalignment among prediabetes adults at 6 months
Time frame: Baseline to 6 months
The change of chronotype among prediabetes adults at 6 months.
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 34444846Wirth 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.
- Background: PubMed 30510391Mezitis 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.
- Background: PubMed 32761356Hawley 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.
- Background: PubMed 26598903Oda H. Chrononutrition. J Nutr Sci Vitaminol (Tokyo). 2015;61 Suppl:S92-4. doi: 10.3177/jnsv.61.S92.
- Background: PubMed 28143856Jiang 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.
- Results publication: PubMed 29375081Sakai 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.
- Results publication: PubMed 28549298Imai 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.
- Results publication: PubMed 30410377Gouda 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.
- Results publication: PubMed 28128995Anothaisintawee 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.
- Derived from this study: PubMed 41810501Chong GY, Kaur S, Abd Talib R, Loy SL, Tan HY, Binti Abdullah R, Binti Mahmud H, Siah WY, Kee CC, Koo HC. Exploration of the longitudinal associations between sleep behaviours, anthropometric measurements and body composition in adults with prediabetes. Chronobiol Int. 2026 Jun;43(6):911-923. doi: 10.1080/07420528.2026.2638533. Epub 2026 Mar 11.
- Derived from this study: PubMed 40832725Chong 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.
- Derived from this study: PubMed 35922777Chong 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No. The validation and reliability of Chrononutrition Profile Questionnaire planned to share with researchers but the other data are not shared with other researchers.
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PreDiabetes and Diabetes Mellitus, Type 2, run by Universiti Tunku Abdul Rahman at 11 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of baseline glycated hemoglobin (HbA1c) among prediabetes adults at 6 months. (time frame: Baseline to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163964, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.