NCT03314246

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 6, 2019

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.8 years

First QC Date

September 20, 2017

Last Update Submit

February 26, 2020

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus, Type 2Ramadan FastingRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    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 Outcomes (10)

  • Incidence of minor and major hypoglycemia

    During one month of Ramadan

  • Incidence of hyperglycemia

    During one month of Ramadan

  • Change in fasting blood glucose (FPG)

    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

    Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)

  • Change in blood pressure

    Baseline Pre-Ramadan (3 months prior to Ramadan), during Ramadan (+ 4 weeks) and post Ramadan (3 months after Ramadan)

  • +5 more secondary outcomes

Study Arms (2)

Intervention

OTHER

FAST user

Other: FAST

Control

OTHER

Standard of care

Other: Standard of care

Interventions

FASTOTHER

Fasting Algorithm for Singaporeans with Type 2 Diabetes

Intervention
Standard of careOTHER

Standard of care

Control

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

National Healthcare Group Polyclinic (Bukit Batok)

Singapore, 659164, Singapore

Location

Related Publications (1)

  • Lee SWH, Chen WS, Sellappans R, Md Sharif SB, Metzendorf MI, Lai NM. Interventions for people with type 2 diabetes mellitus fasting during Ramadan. Cochrane Database Syst Rev. 2023 Jul 12;7(7):CD013178. doi: 10.1002/14651858.CD013178.pub2.

    PMID: 37435938DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Lee, Pharm D

    National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 20, 2017

First Posted

October 19, 2017

Study Start

April 3, 2017

Primary Completion

February 6, 2019

Study Completion

February 6, 2019

Last Updated

February 28, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SG(2)