The Effect of Fasting on Serum Osmolarity in Diabetic Patients
May 16, 2020 updated by: Mirac Vural Keskinler, Istanbul Medeniyet University
The Effect of Ramadan Fasting on Serum Osmolarity in Patients With Type 2 Diabetes
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.
Study Overview
Detailed Description
Till recently, it was assumed that patients with type 2 diabetes have to eat frequently, especially to avoid hypoglycemia, which is still true if they are using sulphonylurea or insulin.
Especially because patients with diabetes often have one or more diabetic complications, they were advised against Ramadan fasting, as it is not allowed to eat or drink anything for long hours.
There are increasing data supporting intermittent fasting, where individuals won't eat anything for 12-18 hours but are permitted to drink sugar-free beverages.
The new antihypoglycemic agents have the advantage of causing very low or no hypoglycemia, which allows these patients to eat less frequently.
There are studies about the metabolic effect of intermittent fasting in patients with type 2 diabetes, but we don't have enough data for the safety of religious fasting where no kind of fluid intake is allowed.
In this study, we aimed to investigate the effect of fasting on the fluid status of diabetic patients.
To this effect, we used serum osmolarity to determine fluid status.
The patients who preferred to fast were our study group, and the patients who were healthy otherwise but preferred not to fast were our control group.
In Ramadan, contrary to the customary practice of intermittent fasting, fasting starts with the sunrise and continues till sunset.
We planned to take the first blood sample at 10 am and the second blood sample at 06 pm in both groups and compare the serum osmolarity accordingly.
Study Type
Observational
Enrollment (Actual)
52
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Kadikoy
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Istanbul, Kadikoy, Turkey
- IMU Goztepe Education and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Outpatients who were attending to the clinics of diabetes in a medical faculty
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- if the patients are not eligible for fasting
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Fasting group
patients with type 2 diabetes who prefer to fast during Ramadan
|
blood samplings will be taken 08:00 am and again 2 hours before breaking the fast
|
|
Non-fasting group
patients with type 2 diabetes who are otherwise healthy and have no contraindications for fasting but prefer not to fast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To compare the serum osmolarities of patients with type 2 diabetes who are fasting for 17 hours and who are not fasting.
Time Frame: 1 month
|
osmolarity is the measure of solute concentration.
In our study we used it as a surrogate marker for fluid loss during fasting
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mirac Vural Keskinler, MD, IMU Doctoral program
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 15, 2019
Primary Completion (Actual)
June 3, 2019
Study Completion (Actual)
June 3, 2019
Study Registration Dates
First Submitted
May 13, 2020
First Submitted That Met QC Criteria
May 16, 2020
First Posted (Actual)
May 19, 2020
Study Record Updates
Last Update Posted (Actual)
May 19, 2020
Last Update Submitted That Met QC Criteria
May 16, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RAMADAN2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.