- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03314246
Development and Implementation of Ramadan Fasting Algorithm for Singaporeans With Type 2 Diabetes (FAST)
Development and Implementation of Ramadan "Fasting Algorithm for Singaporeans With Type 2 Diabetes" (FAST): A Prospective Randomized Controlled Intervention Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Singapore, Singapore, 308433
- Tan Tock Seng Hospital
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Singapore, Singapore, 659164
- National Healthcare Group Polyclinic (Bukit Batok)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Intervention
FAST user
|
Fasting Algorithm for Singaporeans with Type 2 Diabetes
|
Other: Control
Standard of care
|
Standard of care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in HbA1c
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Change in HbA1c during and after Ramadan from baseline
|
Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of minor and major hypoglycemia
Time Frame: During one month of Ramadan
|
Incidence of minor hypoglycemia which is defined as signs and symptoms with known precipitating causes such as irregular eating habits, increased daily activity or other attributes that can be modified.
Major hypoglycemia is defined as any hypoglycemic symptoms that require the help from another person.
|
During one month of Ramadan
|
Incidence of hyperglycemia
Time Frame: During one month of Ramadan
|
Incidence of hyperglycemia which is defined as signs and symptoms of frequent urination, increased thirst or fruity-smelling breath.
|
During one month of Ramadan
|
Change in fasting blood glucose (FPG)
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Change in FPG during and after Ramadan from baseline
|
Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Change in post-prandial blood glucose
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Change in 2 hours post meal during and after Ramadan from baseline
|
Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Change in blood pressure
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Change in BP during and after Ramadan from baseline
|
Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)
|
Change in lipid panel
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and post Ramadan (3 months after Ramadan)
|
including LDL, TG, TC, HDL
|
Baseline Pre-Ramadan (3 months prior to Ramadan) and post Ramadan (3 months after Ramadan)
|
Change in general health status
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
EQ-5D-5L
|
Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
Change in diabetes-related distress
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
Problem Area in Diabetes (PAID)
|
Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
Change in diabetes-specific quality of life
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
Audit of Diabetes Dependent Quality of Life (ADDQoL)
|
Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
Change in diabetes treatment satisfaction
Time Frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
Diabetes Treatment Satisfaction Questionnaires (DTSQ)
|
Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lee, Pharm D, National University of Singapore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/00290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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