Type 2 Diabetes Mellitus
Conditions
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.
Interventions
OTHERNutrition 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)
OTHERUsual Care
Subjects in the group continue with the usual care
Sponsors
Nestle Health Science
Joslin Diabetes Center
Universiti Putra Malaysia
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants are assigned to two groups in parallel for the duration of the study based on their choice
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 functional status | 12 weeks | Changes in hand grip strength |
| Efficacy potential on body mass index | 12 weeks | Changes in body mass index |
| Efficacy potential on glycemic control | 12 weeks | Changes in HbA1c levels |
Countries
Malaysia
Contacts
Primary ContactBarakatun-Nisak Mohd Yusof, PhD
Outcome results
None listed