Status:
UNKNOWN
Malaysia Diabetes Ramadan Nutrition Plan (My Dia-RNP®): A Feasibility Study
Lead Sponsor:
Universiti Putra Malaysia
Collaborating Sponsors:
Nestle Health Science
Joslin Diabetes Center
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 M...
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 pr...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT03817099
Start Date
April 1 2019
End Date
December 30 2019
Last Update
August 12 2019
Active Locations (1)
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1
Universiti Putra Malaysia
Serdang, Selangor, Malaysia, 43400