Clinical trial NCT03314246: Development and Implementation of Ramadan Fasting Algorithm for Singaporeans With Type 2 Diabetes
Official title: Development and Implementation of Ramadan "Fasting Algorithm for Singaporeans With Type 2 Diabetes" (FAST): A Prospective Randomized Controlled Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Ramadan Fasting
Randomized controlled trial
Lead sponsor: National University of Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
name: Tan Tock Seng Hospital
name: National Healthcare Group, Singapore
First posted: 2017-10-19
Enrollment: 111
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background: Ramadan fasting is a religious observance carried out by Muslims all over the world. During Ramadan, Muslims abstain from eating, drinking, and smoking during daylight hours. Although Muslims who are ill, including patients with diabetes, are exempted from fasting, many devoted Muslim patients still insist on fasting despite being advised not to by their healthcare providers. Concerns have been raised over how the practice of fasting may affect the metabolic control of Muslim patients with diabetes. Furthermore, it has also been postulated that the act of fasting may increase the risk of hypoglycemia or glucose toxicity. Although practice algorithms and suggestions on the use of glycemic therapies during fasting have been discussed internationally. they are not generalizable as the observances of Ramadan, duration of fasting and the food ingested differ from one country to another.

Aims: This study aims to develop and implement a clinical practice dose-adjustment algorithm dedicated to the care of Singaporean patients with diabetes who fast during Ramadan.

Hypothesis: The use of clinical practice dose-adjustment algorithm can improve both clinical and humanistic outcomes of patients with type 2 diabetes who wish to fast during Ramadan.

Methods: This is a prospective, randomized, interventional study involving patients with type 2 diabetes who wish to fast for at least 10 days during Ramadan. Eligible patient attending a primary care institution or an outpatient specialist clinic of a tertiary institution will be approached to participate in the study. Consented patients will be randomized to either intervention arm or control arm. Patients in the control arm will receive usual care while patients in the intervention arm will be given additional education session on Ramadan fasting related diabetic management advice and an algorithm that was developed by the study team members based on international guidelines, to guide them on self-management during Ramadan. The primary outcomes will be change in HbA1c. Secondary outcomes include change in fasting blood glucose, post prandial blood glucose, medication adherence and humanistic outcomes. The safety outcomes include self reported incidence of major and minor hypoglycemia as well as hyperglycemia during Ramadan month. All outcomes will be measured at baseline, during Ramadan and at 3 month post Ramadan.

Significance: The validation of the algorithm through this study will ensure effective and safe fasting of patients with type 2 diabetes during Ramadan.


Eligibility criteria: Inclusion Criteria:

* All Muslim patients over 21 years of age with Type 2 diabetes who plan to fast for at least 10 days during the month of Ramadan

Exclusion Criteria:

* Patients with history of recurrent hypoglycemia
* Patients who are pregnant
* Patients with eGFR\<30ml/min 3 months prior to Ramadan
* Patients with HbA1c \> 9.5%
* Patients with DM-related admission 1 month prior to Ramadan
* Patients on active short-term corticosteroid treatment
* Patients who are unable to complete the questionnaires

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
Secondary outcomes:
measure: Incidence of minor and major hypoglycemia
timeFrame: During one month of Ramadan
measure: Incidence of hyperglycemia
timeFrame: During one month of Ramadan
measure: Change in fasting blood glucose (FPG)
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
measure: Change in post-prandial blood glucose
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
measure: Change in blood pressure
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
measure: Change in lipid panel
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan) and post Ramadan (3 months after Ramadan)
measure: Change in general health status
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
measure: Change in diabetes-related distress
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
measure: Change in diabetes-specific quality of life
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
measure: Change in diabetes treatment satisfaction
timeFrame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Singapore
country: Singapore
facility: National Healthcare Group Polyclinic (Bukit Batok)
Study officials:
affiliation: National University of Singapore
name: Lee, Pharm D
role: PRINCIPAL_INVESTIGATOR
References: