NCT04356898

Brief Summary

Many Muslim patients with diabetes observe dawn to sunset fasting during the month of Ramadan. Hyperglycaemia and hypoglycaemia are possible problems amongst these patients. The aim of this study is to investigate glucose profiles in diabetes and non-diabetes patients that decided to fast or not to fast during Ramadan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

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 15, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
Last Updated

April 24, 2020

Status Verified

October 1, 2018

Enrollment Period

12 months

First QC Date

October 18, 2018

Last Update Submit

April 22, 2020

Conditions

Diabetes Mellitus

Keywords

Type 1 DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (4)

  • Change in mean glucose level; (mmol/L)

    This primary outcome is aimed at measurement of change in mean glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • Change in percentage of time in target blood glucose range (3.9 - 10.0 mmol/L); (%)

    This primary outcome is aimed at measurement of change in percentage of time in target blood glucose range,in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • Coefficient of variance (CV); (coefficient; no units)

    This primary outcome is aimed at measurement of coefficient of variance of blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • Area under the curve (AUC); ((mmol/L)*h)

    This primary outcome is aimed at measurement of area under the curve for blood glucose, in patients with diabetes, at the time points/frames indicated (Pre-Ramadan, Ramadan and Post-Ramadan).

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

Secondary Outcomes (8)

  • Change in glucose management indicator (GMI) ; (index; no units)

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • Change in percentage of time in level 1 (<3.9 - 10.0 mmol/L) hypoglycaemic range (mmol/L); (%)

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • Change in percentage of time in level 2 (<3.0 mmol/l) hypoglycaemic range (mmol/L); (%)

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • Change in percentage of time in level 1 (>10.0 mmol/L); (%)

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • Change in percentage of time in level 2 (>13.9 mmol/L); (%)

    Pre-Ramadan (30 days), Ramadan (29 days), Post-Ramadan (30 days)

  • +3 more secondary outcomes

Study Arms (3)

Diabetes fasting

Diabetes patients who decided to fast during the month of Ramadan

Other: No intervention

Diabetes non-fasting

Diabetes patients who decided to not fast during the month of Ramadan

Other: No intervention

Healthy

Healthy volunteers that decided to fast during the month of Ramadan

Other: No intervention

Interventions

No interventionOTHER

No intervention

Diabetes fastingDiabetes non-fastingHealthy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • diabetes, age\>=18

You may not qualify if:

  • pregnancy, renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imperial College London Diabetes Centre

Abu Dhabi, 48338, United Arab Emirates

Location

Imperial College London Diabetes Centre

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nader Lessan, MD FRCP

    Imperial College London Diabetes Center (ICLDC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2018

First Posted

April 22, 2020

Study Start

April 15, 2018

Primary Completion

March 31, 2019

Study Completion

December 31, 2019

Last Updated

April 24, 2020

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

AE(2)