The Effect of Fasting on Serum Osmolarity in Diabetic Patients

NCT ID: NCT04392570

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-15

Study Completion Date

2019-06-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Fasting group

patients with type 2 diabetes who prefer to fast during Ramadan

Fasting

Intervention Type DIAGNOSTIC_TEST

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

No interventions assigned to this group

Interventions

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Fasting

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medeniyet University

OTHER

Sponsor Role lead

Responsible Party

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Mirac Vural Keskinler

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mirac Vural Keskinler, MD

Role: PRINCIPAL_INVESTIGATOR

IMU Doctoral program

Locations

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IMU Goztepe Education and Research Hospital

Istanbul, Kadikoy, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type DERIVED
PMID: 37051980 (View on PubMed)

Other Identifiers

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RAMADAN2020

Identifier Type: -

Identifier Source: org_study_id

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