An interventional study of Ramadan Nutrition Plan (RNP) and RNP Printed guidebook in T2DM (Type 2 Diabetes Mellitus) and Ramadan Fasting, sponsored by Universiti Putra Malaysia. Not yet recruiting at 1 site in Indonesia. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Universiti Putra Malaysia · Not applicable, Interventional, and Treatment
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Among 12 studies in Diabetes Mellitus, Type 2 by Universiti Putra Malaysia — 3 open to participants now, 3 under way, none of them phase 3. Diabetes Mellitus, Type 2 · Universiti Putra Malaysia.
Among the 12 studies in Diabetes Mellitus, Type 2 by Universiti Putra Malaysia, this one is the 4th largest by planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2026, is one of 10 with no phase, and was the 12th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →3 of the 12 studies in Diabetes Mellitus, Type 2 by Universiti Putra Malaysia are open now, in 3 countries. Recruiting first, the newest first:
Universiti Putra Malaysia · Sites in Malaysia
Ages 18–80
Universiti Putra Malaysia · Sites in Pakistan
Ages 18–85
By country, each count listing its studies:
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 60 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 133 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 113 across the 10 interventional studies, 303 across the 2 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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Universiti Putra Malaysia is the lead sponsor of 146 studies on the registry; 51 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Diabetes Mellitus, Type 2 by Universiti Putra Malaysia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to evaluate whether the RNP Book improves glycemic control and other diabetes-related outcomes among older adults with diabetes during Ramadan. The study will also assess participants' dietary intake, nutritional knowledge, anthropometric measurements, and clinical characteristics, as well as the reach and dose received of the RNP intervention.
The main questions it aims to answer is:
Does the RNP Book improve glycemic control among older adults with diabetes during Ramadan? Does the RNP Book lead to changes in anthropometric measurements, clinical characteristics, dietary intake, and nutritional knowledge compared with national guidelines?
Researchers will compare diabetes nutrition education using the RNP Book or national guidelines to determine whether the RNP Book leads to improvements in glycemic control and other diabetes-related outcomes.
Participants will:
Attend educational session on diabetes nutrition management during Ramadan using either the RNP Book or national guidelines, according to their assigned study group.
Receive 15 minutes of individualized nutritional counseling from a nutritionist.
Follow the nutritional rekomendation provided during Ramadan, with on going support through WhatsApp messaging Participate complete follow-up assessments and final evaluation
Following the initial screening and enrollment process, participants will undergo baseline assessments to establish their initial health and nutritional status before the educational intervention. These assessments will provide reference information for evaluating changes during the study.
The study will include scheduled monitoring activities during the follow-up period. Fasting glucose assessments will be conducted at weeks 6 and 8 following the educational session to monitor participants' glycemic status. Participants will also record their dietary intake for three days at three designated time points using the study monitoring and evaluation (M\&E) book. This approach will allow dietary information to be documented at different stages of the study.
At the end of the 12-week follow-up period, participants will complete a post-intervention evaluation. The baseline assessments will be repeated to allow comparison of participants' health and nutritional status before and after the intervention.
In addition to evaluating the study outcomes, the implementation of the RNP intervention will be assessed through its reach and dose received.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants receive the Ramadan Nutrition Plan (RNP), a structured nutrition education program for older adults with type 2 diabetes mellitus who plan to fast during Ramadan. The program runs for 12 weeks, with sessions at week 0, week 6, week 8, and week 12. The education covers the risks of fasting, the principles of the RNP, the "3J+" approach to food intake (type, amount, and schedule of food, including protein), the Ramadan plate, fluid intake, physical activity, and the Syawal food plan. Participants receive a printed RNP guidebook designed for older adults. Of all participants in this arm, 30 are randomly selected to receive a glucometer for self-monitoring of blood glucose (SMBG) and to record the results in an SMBG log.
Behavioral: Ramadan Nutrition Plan (RNP) · Other: RNP Printed guidebook · Device: Self-monitoring of blood glucose (SMBG)
Participants receive education based on national guidelines for diabetes management and printed leaflet, in primary care over the same 12-week period. They do not receive the RNP education sessions or the printed RNP guidebook. After Syawal, they are offered the RNP module.
Other: RNP Printed guidebook · Behavioral: Standard Care (in control arm) · Other: Printed Leaflet Standard Care
Education sessions that teach participants how to plan and adjust their food, fluid intake, and physical activity for Ramadan fasting, following the Ramadan Nutrition Plan framework. Sessions are held at week 0. The session last for 45 minutes, delivered by Nutritionist and is held in group format.
A printed guidebook for older adults containing the RNP material taught in the sessions. Participants keep the guidebook and are expected to read and use it at home throughout the program as a reference for their daily choices.
A glucometer provided to 30 randomly selected participants in the intervention arm. Participants measure their own blood glucose twice a day and record each result in an SMBG monitoring and evaluation log.
Education sessions that teach participants how to plan and adjust their food for Ramadan fasting, following the National Guidelines for DM Management. Sessions are held at week 0. The session held for 45 minute, delivered by nutritionist, and is held in group format
A printed leaflet for older adults containing the standard care management in the sessions. Participants keep the leaflet and are expected to read and use it at home throughout the program as a reference for their daily choices.
Changes in Hemoglobin A1c (HbA1C)
HbA1c is the percentage of hemoglobin in red blood cells that is bound to glucose. It reflects average blood glucose over the previous 2 to 3 months. It was measured from a venous blood sample using the AFIAS analyzer at two point times, baseline of the intervention (week 0) and the end of the intervention (week 12). A higher percentage indicates poorer glycemic control and a lower percentages indicates better control.
Time frame: 12 week
Changes and Differences of Macronutrients Intake
Macronutrients intake was calculated from a three-days food record completed by each participant. It covers energy, protein, fat, and carbohydrate intake. Energy is reported in kilocalories (kcal), protein, fat, and carbohydrate in grams (g). Each macronutrient also reported as a percentage of total energy intake. Mean intake was compared within each group over time to assess change and between the intervention and control group to assess differences. Data was collected at three times point baseline of the intervention (week 0), middle of intervention (week 8), and the end of the intervention (week 12).
Time frame: 12 week
Changes in Body Weight
Body weight was measured in kilograms (kg) with a digital scale, with the participant standing. The change was calculated as the different between baseline of the intervention (week 0) and the end of the intervention (week 12).
Time frame: 12 week
Changes in Body Mass Index (BMI)
Body Mass Index is the ratio of the subject weight in kilograms divided by the square of their height in meters (kg/m2). The change in BMI is calculated as the difference between baseline of the intervention (week 0) and the end of the intervention (week 12).
Time frame: 12 week
Changes in Waist Circumference
Waist circumference is a simple physical measurement taken using a measuring tape (metline) around the abdomen (midpoint between the lowest rib and the iliac crest) and reported in centimeters (cm). It is used to estimate central obesity. The change in waist circumference is calculated as the different between the waist circumference value at the baseline of the intervention (week 0) and the end of the intervention (week 12).
Time frame: 12 week
Changes in Hand Grip Strength
Hand grip strength was measured with a hand grip dynamometer and reported as kilograms (kg). The changes was calculated as the different between the baseline of the intervention (week 0) and the end of the intervention (week 12).
Time frame: 12 week
Changes in Systolic Blood Pressure
Systolic blood pressure was measured by registered nurse using a sphygmomanometer and reported in millimeters of mercury (mmHg). The changes was calculated as the different between the baseline of the intervention (week 0) and the end of the intervention (week 12).
Time frame: 12 week
Changes in Diastolic Blood Pressure
Diastolic blood pressure was measured by registered nurse using a sphygmomanometer and reported in millimeters of mercury (mmHg). The changes was calculated as the different between the baseline of the intervention (week 0) and the end of the intervention (week 12).
Time frame: 12 week
Different Fasting blood glucose between group
Fasting blood glucose was measure from a capillary blood sample after 10 hours of fasting and reported in mg/dL. It was measured twice, at week 6 and week 8 of intervention. Mean blood glucose was compared between the control group and the intervention group at each time point.
Time frame: week 6 and week 8 after the start of intervention
Proportion of participants with hypoglycemia and hyperglycemia by group
Fasting blood glucose was measured from a capillary blood sample taken after 10 hours of fasting and reported in mg/dL. Participants were classified into three categories based on their fasting blood glucose: hypoglycemia (below 70 mg/dL), normal (70 to 125 mg/dL), and hyperglycemia (above 125 mg/dL). The number and percentage of participants in each category were compared between the intervention group and the control group at each time point.
Time frame: week 6 and week 8 after the start of intervention
Changes in Knowledge
Knowledge about the RNP was measured with questionnaire based on the structured of RNP book. The questionnaire has 15 questions. Each question was answered true, false, or do not know. The correct answer score 1 point and an incorrect answer or do not know answer score 0. Total score range from 0 to 15. The changes was calculated as the different between the baseline before education session (week 0) and the end of the intervention (week 12).
Time frame: 12 week
Reach
Reach was the proportion of invited participants who attended the intervention sessions. It was taken from the participant attendance log and calculated as the number of participants who attended divided by the number of participants invited, multiplied by 100, and reported as a percentage. Values range from 0% to 100%. Attendance was recorded at four sessions (week 0, week 6, week 8, and week 12).
Time frame: 12 week
Dose received of RNP
Dose received was the extent to which participants read and actively utilized the RNP educational materials and guidelines throughout Ramadan. It was assessed with a self-developed questionnaire completed by participant themselves at the end of the intervention.
Time frame: 12 week
Dose Received of SMBG
Dose received of SMBG was the extent to which participants carried out SMBG as instructed in the intervention. It was taken from the SMBG monitoring and evaluation log, which participants completed themselves. Calculated as the number of SMBG measurements recorded in the log divided by the number of measurements recommended, multiplied by 100, and reported as a percentage.
Time frame: Week 6 until week 9 after the start of intervention
Plan to share: No — Individual participant data will not be shared to protect patient privacy and confidentiality, in accordance with the informed consent signed by the participants and the restrictions set by the Ethics Committee.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Mar 2028, 15 months later.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 15 months is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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