Clinical trial NCT03817099: Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Nestle Health Science
name: Joslin Diabetes Center
First posted: 2019-01-25
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to two groups in parallel for the duration of the study based on their choice
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of participants completed the study
timeFrame: 12 weeks
Secondary outcomes:
measure: Rate of participants adhered to the intervention
timeFrame: 12 weeks
measure: Efficacy potential on the rate of hypoglycemia
timeFrame: 12 weeks
measure: Efficacy potential on the fructosamine level
timeFrame: 4 weeks
measure: Efficacy potential on fasting glucose
timeFrame: 12 weeks
measure: Efficacy potential on glycemic control
timeFrame: 12 weeks
measure: Efficacy potential on functional status
timeFrame: 12 weeks
measure: Efficacy potential on body mass index
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Serdang
country: Malaysia
facility: Universiti Putra Malaysia
state: Selangor
Study officials:
affiliation: Universiti Putra Malaysia
name: Barakatun-Nisak Mohd Yusof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Wan Zul Haikal Hafiz Wan Zukiman, Mmed
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Noraida Omar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Zalina Abu Zaid, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Azrina Azlan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Firdaus Mamat @ Mukhtar, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Norhasmah Sulaiman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Siti NurA'syura Adznam, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Nur Maziah Hanum Osman, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: Universiti Putra Malaysia
name: Nor Farahain Yahya, Degree
role: PRINCIPAL_INVESTIGATOR
affiliation: Joslin Diabetes Centre
name: Osama Hamdy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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