Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study
NCT ID: NCT03817099
Last Updated: 2019-08-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
53 participants
INTERVENTIONAL
2019-04-01
2019-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Feasibility and Efficacy of Intermittent Use of a Fasting Mimicking Diet in the Treatment of Type 2 Diabetes
NCT03811587
Association Between Insulin Resistance and Beta Cell Function With HbA1C in Diabetics
NCT03196154
Exploring Nutritype Signature of Type 2 Diabetes Risks in Women Post-Gestational Diabetes Mellitus
NCT04190199
Effect of Eating Within a Limited Time on Sugar Sensitivity and Liver Sugar Stores of People With Type 2 Diabetes.
NCT03992248
Time-Restricted Feeding on Glucose Homeostasis and Quality of Life
NCT04062773
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Ramadan Nutrition Plan (RNP) has recently published by the International Diabetes Federation (IDF) and the Diabetes and Ramadan (DAR) International Alliance IDF-DAR guidelines. The goal is to provide comprehensive guidance on nutrition practice during Ramadan. However, its feasibility in the real clinical scenarios warrants further investigation.
Besides, the use of a diabetes-specific nutrition formula (Nutren Untuk Diabetik®) has been shown beneficial in improving blood glucose control and managing body weight as well as enhancing the nutrient adequacy among people with diabetes (Hamdy and Barakatun-Nisak 2016). While the benefits have been well established, no study has explored its potential during Ramadan.
Malaysia Diabetes-Ramadan Nutrition Plan (My Dia-RNP) is proposed to determine the feasibility of implementing the RNP and to incorporate the diabetes-specific nutrition formula (Nutren Untuk Diabetik®) during Ramadan on dietary adherence and acceptability in patients with type 2 diabetes mellitus.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
My Dia-RNP
In the My Dia-RNP group, participants will undergo the pre-RNP assessment 2 weeks before Ramadan. They will be given a nutrition education based on the Ramadan Nutrition Plan Guide published by IDF-DAR Practical Guidelines. They will also be asked to incorporate diabetes-specific nutrition formula (Nutren untuk Diabetik®) within the prescribed calories before Ramadan period to help them familiarise with a dietary change.
Nutrition Intervention based on My Dia-RNP
Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)
Usual Care
Participant in this group will continue in a usual care (UC) group. They will receive dietary advice based on the Practical Guide to Diabetes Management in Ramadan produced by Ministry of Health (2015).
Usual Care
Subjects in the group continue with the usual care
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nutrition Intervention based on My Dia-RNP
Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)
Usual Care
Subjects in the group continue with the usual care
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Have a confirmed diagnosis of T2D for at least 6 months
* BMI \> 18.5 but \< 40 kg/m2
* HbA1c of \> 6.5% but \< 10%
* On a stabilised dose of oral anti-diabetes agents (OAD) for the past 2 months prior to the study
* Willing to fast for at least 15 days during Ramadan
Exclusion Criteria
* Liver disease
* Abnormal liver function test or renal profiles
* On insulin injection
* Reported abnormal thyroid stimulating hormones
* Use of medications known to effect lipid or glucose metabolism such as steroid
* Pregnancy or the desire to become pregnant in the next 3 months
* On any weight loss program or weight loss medications
* History of cancer undergoing active treatment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nestle Health Science
INDUSTRY
Joslin Diabetes Center
OTHER
Universiti Putra Malaysia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Barakatun Nisak Bt Mohd Yusof
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Barakatun-Nisak Mohd Yusof, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Wan Zul Haikal Hafiz Wan Zukiman, Mmed
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Noraida Omar, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Zalina Abu Zaid, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Azrina Azlan, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Firdaus Mamat @ Mukhtar, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Norhasmah Sulaiman, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Siti NurA'syura Adznam, PhD
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Nur Maziah Hanum Osman, Master
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Nor Farahain Yahya, Degree
Role: PRINCIPAL_INVESTIGATOR
Universiti Putra Malaysia
Osama Hamdy, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universiti Putra Malaysia
Serdang, Selangor, Malaysia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Babineaux SM, Toaima D, Boye KS, Zagar A, Tahbaz A, Jabbar A, Hassanein M. Multi-country retrospective observational study of the management and outcomes of patients with Type 2 diabetes during Ramadan in 2010 (CREED). Diabet Med. 2015 Jun;32(6):819-28. doi: 10.1111/dme.12685. Epub 2015 Apr 10.
Bujang MA, Ismail M, Hatta NKBM, Othman SH, Baharum N, Lazim SSM. Validation of the Malay version of Diabetes Quality of Life (DQOL) Questionnaire for Adult Population with Type 2 Diabetes Mellitus. Malays J Med Sci. 2017 Aug;24(4):86-96. doi: 10.21315/mjms2017.24.4.10. Epub 2017 Aug 18.
Campbell M, Fitzpatrick R, Haines A, Kinmonth AL, Sandercock P, Spiegelhalter D, Tyrer P. Framework for design and evaluation of complex interventions to improve health. BMJ. 2000 Sep 16;321(7262):694-6. doi: 10.1136/bmj.321.7262.694. No abstract available.
Hamdy O, Barakatun-Nisak MY. Nutrition in Diabetes. Endocrinol Metab Clin North Am. 2016 Dec;45(4):799-817. doi: 10.1016/j.ecl.2016.06.010.
Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Type 2 diabetes patient's perspective on Ramadan fasting: a qualitative study. BMJ Open Diabetes Res Care. 2017 May 8;5(1):e000365. doi: 10.1136/bmjdrc-2016-000365. eCollection 2017.
Lee SWH, Lee JY, Tan CSS, Wong CP. Strategies to Make Ramadan Fasting Safer in Type 2 Diabetics: A Systematic Review and Network Meta-analysis of Randomized Controlled Trials and Observational Studies. Medicine (Baltimore). 2016 Jan;95(2):e2457. doi: 10.1097/MD.0000000000002457.
Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Telemonitoring in fasting individuals with Type 2 Diabetes Mellitus during Ramadan: A prospective, randomised controlled study. Sci Rep. 2017 Aug 31;7(1):10119. doi: 10.1038/s41598-017-10564-y.
Lessan N, Hannoun Z, Hasan H, Barakat MT. Glucose excursions and glycaemic control during Ramadan fasting in diabetic patients: insights from continuous glucose monitoring (CGM). Diabetes Metab. 2015 Feb;41(1):28-36. doi: 10.1016/j.diabet.2014.11.004. Epub 2014 Dec 10.
Salti I, Benard E, Detournay B, Bianchi-Biscay M, Le Brigand C, Voinet C, Jabbar A; EPIDIAR study group. A population-based study of diabetes and its characteristics during the fasting month of Ramadan in 13 countries: results of the epidemiology of diabetes and Ramadan 1422/2001 (EPIDIAR) study. Diabetes Care. 2004 Oct;27(10):2306-11. doi: 10.2337/diacare.27.10.2306.
Hassanein M, Al-Arouj M, Hamdy O, Bebakar WMW, Jabbar A, Al-Madani A, Hanif W, Lessan N, Basit A, Tayeb K, Omar M, Abdallah K, Al Twaim A, Buyukbese MA, El-Sayed AA, Ben-Nakhi A; International Diabetes Federation (IDF), in collaboration with the Diabetes and Ramadan (DAR) International Alliance. Diabetes and Ramadan: Practical guidelines. Diabetes Res Clin Pract. 2017 Apr;126:303-316. doi: 10.1016/j.diabres.2017.03.003. Epub 2017 Mar 12.
Jadviscokova T, Fajkusova Z, Pallayova M, Luza J, Kuzmina G. Occurence of adverse events due to continuous glucose monitoring. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2007 Dec;151(2):263-6. doi: 10.5507/bp.2007.044.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MyDia-RNP study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.