The Effect of Fasting on Serum Osmolarity in Diabetic Patients

Sponsor
Istanbul Medeniyet University (Other)
Overall Status
Completed
CT.gov ID
NCT04392570
Collaborator
(none)
52
1
19
83.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Fasting

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 Design

Study Type:
Observational
Actual Enrollment :
52 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Ramadan Fasting on Serum Osmolarity in Patients With Type 2 Diabetes
Actual Study Start Date :
May 15, 2019
Actual Primary Completion Date :
Jun 3, 2019
Actual Study Completion Date :
Jun 3, 2019

Arms and Interventions

Arm Intervention/Treatment
Fasting group

patients with type 2 diabetes who prefer to fast during Ramadan

Diagnostic Test: Fasting
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

Outcome Measures

Primary Outcome Measures

  1. To compare the serum osmolarities of patients with type 2 diabetes who are fasting for 17 hours and who are not fasting. [1 month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IMU Goztepe Education and Research Hospital Istanbul Kadikoy Turkey

Sponsors and Collaborators

  • Istanbul Medeniyet University

Investigators

  • Principal Investigator: Mirac Vural Keskinler, MD, IMU Doctoral program

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mirac Vural Keskinler, Principal Investigator, Istanbul Medeniyet University
ClinicalTrials.gov Identifier:
NCT04392570
Other Study ID Numbers:
  • RAMADAN2020
First Posted:
May 19, 2020
Last Update Posted:
May 19, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mirac Vural Keskinler, Principal Investigator, Istanbul Medeniyet University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 19, 2020