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Completed

NCT Number: NCT03314246

Development and Implementation of Ramadan Fasting Algorithm for Singaporeans With Type 2 Diabetes

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.

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Key information

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Healthcare Group Polyclinic (Bukit Batok), Singapore

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FAST

Other

Fasting Algorithm for Singaporeans with Type 2 Diabetes

Standard of care

Other

Standard of care

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. Change in general health status

    Time frame: Baseline Pre-Ramadan (3 months prior to Ramadan) and during Ramadan (+ 4 weeks)

    EQ-5D-5L

  8. 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)

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

Joyce Lee

Other

Collaborators

  • National Healthcare Group, Singapore
  • National University of Singapore
  • Tan Tock Seng Hospital

Registry information

Official study title

Development and Implementation of Ramadan "Fasting Algorithm for Singaporeans With Type 2 Diabetes" (FAST): A Prospective Randomized Controlled Intervention Study

Acronym: FAST

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2017
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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