Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study

Type 2 Diabetes Mellitus Clinical Trial

— MyDia-RNP  

Official title:

Effects of Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP) on Adherence, Acceptability, Efficacy Potential and Quality of Life in Patients With Type 2 Diabetes Mellitus: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03817099
• Other study ID #: MyDia-RNP study
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: December 30, 2019

Study information

• Verified date: August 2019
• Source: Universiti Putra Malaysia
• Contact: Barakatun-Nisak Mohd Yusof, PhD
• Phone: 03-89472524
• Email: bnisak[@]upm.edu.my
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Ramadan fasting is an important event for Muslims. During Ramadan, all healthy Muslims are asked to abstain from food and drink throughout the day and eat only during daybreak (also know as Sahur in Malay/Arabic language) and after sunset (also know as Iftar in Malay/Arabic language). Patients with type 2 diabetes (T2DM) can be exempted from fasting but most of them do not perceive themselves as sick, and they continue to fast. With so many Muslims with diabetes choosing to fast, there is an immediate need for evidence-based nutrition practice guidelines. This study is conducted to determine the feasibility of implementing the Ramadan Nutrition Plan named My Dia-RNP that is also incorporating diabetes-specific nutrition formula on dietary adherence and acceptability in patients with type 2 diabetes mellitus. We hypothesized that My Dia-RNP is feasible to be practiced by patients with type 2 diabetes.

Description:

In Malaysia, average fasting duration is about 14 hours which could potentially cause hypoglycemia, hyperglycemia, ketoacidosis, and dehydration among people with diabetes. Also, Ramadan triggers a prime dietary change leading to increased risk of nutritional issues from improper eating habits and reduction in physical activity level (Hamdy et al., 2016). Ramadan fasting, therefore, represents a challenge to both patients and healthcare professionals (HCPs) including dietitians.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 53
• Est. completion date: December 30, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All Muslim patients aged > 18 years old

• 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:

• History of hypoglycaemia leading to hospitalization during the previous Ramadan

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Other:
• 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

Locations

Country	Name	City	State
Malaysia	Universiti Putra Malaysia	Serdang	Selangor

Sponsors (3)

Lead Sponsor	Collaborator
Universiti Putra Malaysia	Joslin Diabetes Center, Nestle Health Science

Country where clinical trial is conducted

Malaysia, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lee SW, Lee JY, Tan CS, 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. Review. — View Citation

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. — View Citation

Salti I, Bénard 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participants completed the study	The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates.	12 weeks
Secondary	Rate of participants adhered to the intervention	Dietary adherence refers to the ability of the participants to adhere to the selected group. This study aims to achieve the completeness of Ramadan Diaries and the able to consume diabetes-specific nutrition formula (Nutren® untuk Diabetik) for at least 75% during the study period.	12 weeks
Secondary	Efficacy potential on the rate of hypoglycemia	Changes in rate of hypoglycemia during Ramadan	12 weeks
Secondary	Efficacy potential on the fructosamine level	Changes in fructosamine levels	4 weeks
Secondary	Efficacy potential on fasting glucose	Changes in fasting blood glucose levels	12 weeks
Secondary	Efficacy potential on glycemic control	Changes in HbA1c levels	12 weeks
Secondary	Efficacy potential on functional status	Changes in hand grip strength	12 weeks
Secondary	Efficacy potential on body mass index	Changes in body mass index	12 weeks