Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT03817099
- Lead Sponsor
- Universiti Putra Malaysia
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 53
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Rate of participants completed the study 12 weeks The ability and likelihood to complete a study successfully with the aim to achieve at least 80% of the study retention rates.
- Secondary Outcome Measures
Name Time Method Rate of participants adhered to the intervention 12 weeks 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.
Efficacy potential on the rate of hypoglycemia 12 weeks Changes in rate of hypoglycemia during Ramadan
Efficacy potential on the fructosamine level 4 weeks Changes in fructosamine levels
Efficacy potential on fasting glucose 12 weeks Changes in fasting blood glucose levels
Efficacy potential on glycemic control 12 weeks Changes in HbA1c levels
Efficacy potential on functional status 12 weeks Changes in hand grip strength
Efficacy potential on body mass index 12 weeks Changes in body mass index
Trial Locations
- Locations (1)
Universiti Putra Malaysia
🇲🇾Serdang, Selangor, Malaysia
Universiti Putra Malaysia🇲🇾Serdang, Selangor, MalaysiaBarakatun-Nisak Mohd Yusof, PhDContact0389472524bnisak@upm.edu.my