NCT04392570

Brief Summary

In Ramadan, Muslims perform a special kind of fasting. Their fasting start with the first lights of the sunrise and end with the sunset. Especially in summer, it is a real challenge, as the time for fasting might be as long as 18 hours, and hot weather might cause severe dehydration. This might be dangerous, especially in patients with diabetes. Serum osmolarity is a good surrogate marker to evaluate the body's fluid content. We aimed to investigate if summertime Ramadan fasting causes further fluid loss in patients with type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

May 15, 2019

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

19 days

First QC Date

May 13, 2020

Last Update Submit

May 16, 2020

Conditions

Keywords

fasting, osmolarity, fluid loss

Outcome Measures

Primary Outcomes (1)

  • To compare the serum osmolarities of patients with type 2 diabetes who are fasting for 17 hours and who are not fasting.

    osmolarity is the measure of solute concentration. In our study we used it as a surrogate marker for fluid loss during fasting

    1 month

Study Arms (2)

Fasting group

patients with type 2 diabetes who prefer to fast during Ramadan

Diagnostic Test: Fasting

Non-fasting group

patients with type 2 diabetes who are otherwise healthy and have no contraindications for fasting but prefer not to fast

Interventions

FastingDIAGNOSTIC_TEST

blood samplings will be taken 08:00 am and again 2 hours before breaking the fast

Fasting group

Eligibility Criteria

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

Outpatients who were attending to the clinics of diabetes in a medical faculty

You may qualify if:

  • patients with type 2 diabetes
  • will accept to give two different blood samples
  • will prefer to fast during Ramadan ( for the intervention group)
  • will prefer not to fast during Ramadan ( for the control group)
  • have good glycemic control

You may not qualify if:

  • if the patients are not eligible for fasting

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMU Goztepe Education and Research Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Location

Related Publications (1)

  • Keskinler MV, Dincer B, Caklili OT, Oguz A. The effect of Ramadan fasting on serum osmolality in diabetic patients. J Pak Med Assoc. 2023 Apr;73(4):767-770. doi: 10.47391/JPMA.3517.

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Mirac Vural Keskinler, MD

    IMU Doctoral program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 19, 2020

Study Start

May 15, 2019

Primary Completion

June 3, 2019

Study Completion

June 3, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations