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

NCT03817099 | Unknown DMC

• 1 other identifier: MyDia-RNP study
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Rate of participants adhered to the intervention

  12 weeks

• Efficacy potential on the rate of hypoglycemia

  12 weeks

• Efficacy potential on the fructosamine level

  4 weeks

• Efficacy potential on fasting glucose

  12 weeks

• Efficacy potential on glycemic control

  12 weeks

Study Arms (2)

My Dia-RNP

EXPERIMENTAL

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.

Other: Nutrition Intervention based on My Dia-RNP

Usual Care

ACTIVE COMPARATOR

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).

Other: Usual Care

Interventions

Nutrition Intervention based on My Dia-RNP OTHER

Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)

My Dia-RNP

Usual Care OTHER

Subjects in the group continue with the usual care

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Nestle Health Science: collaborator
• Joslin Diabetes Center: collaborator

Study Sites (1)

Universiti Putra Malaysia

Serdang, Selangor, 43400, Malaysia

RECRUITING

Related 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.

  PMID: 25581456 BACKGROUND

• 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.

  PMID: 28951693 BACKGROUND

• 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.

  PMID: 10987780 BACKGROUND

• 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.

  PMID: 27823606 BACKGROUND

• 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.

  PMID: 28761651 BACKGROUND

• 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.

  PMID: 26765440 BACKGROUND

• 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.

  PMID: 28860546 BACKGROUND

• 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.

  PMID: 25497966 BACKGROUND

• 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.

  PMID: 15451892 BACKGROUND

• 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.

  PMID: 28347497 BACKGROUND

• 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.

  PMID: 18345261 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Barakatun-Nisak Mohd Yusof, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Wan Zul Haikal Hafiz Wan Zukiman, Mmed

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Noraida Omar, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Zalina Abu Zaid, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Azrina Azlan, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Firdaus Mamat @ Mukhtar, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Norhasmah Sulaiman, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Siti NurA'syura Adznam, PhD

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Nur Maziah Hanum Osman, Master

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Nor Farahain Yahya, Degree

  Universiti Putra Malaysia

  PRINCIPAL INVESTIGATOR

• Osama Hamdy, MD, PhD

  Joslin Diabetes Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barakatun-Nisak Mohd Yusof, PhD

CONTACT

03-89472524; bnisak@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants are assigned to two groups in parallel for the duration of the study based on their choice

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 25, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 30, 2019
• Last Updated: August 12, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)