Type2 DiabetesNCT04392570
The Effect of Fasting on Serum Osmolarity in Diabetic Patients
An observational study of Type2 Diabetes, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- Fasting
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2019to 3 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients who were attending to the clinics of diabetes in a medical faculty
Who may be able to join
- 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
Who cannot join
- if the patients are not eligible for fasting
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
IMU Goztepe Education and Research Hospital
Istanbul, Kadikoy
About this study
Official title: 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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- Fasting
- Keywords
- fasting, osmolarity, fluid loss
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingDiagnostic test
blood samplings will be taken 08:00 am and again 2 hours before breaking the fast
| Study group | Role | What they receive |
|---|---|---|
| Fasting group | patients with type 2 diabetes who prefer to fast during Ramadan Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start15 May 2019
- Primary completion3 Jun 2019
- Study completion3 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mirac Vural Keskinler, Istanbul Medeniyet University
- Investigators
- Mirac Vural Keskinler, MD, Principal investigator, IMU Doctoral program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392570
- Sponsor's protocol ID
- RAMADAN2020
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37051980
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ramadan Fasting on Serum Osmolarity in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04392570
- Acronym / sponsor ID
- RAMADAN2020
- Conditions
- Type2 Diabetes
- Keywords
- fasting, osmolarity, fluid loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 15 May 2019 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 3 Jun 2019 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting group | – | Diagnostic Test: Fastingpatients with type 2 diabetes who prefer to fast during Ramadan |
| Non-fasting group | – | –patients with type 2 diabetes who are otherwise healthy and have no contraindications for fasting but prefer not to fast |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients who were attending to the clinics of diabetes in a medical faculty
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- if the patients are not eligible for fasting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fastingblood samplings will be taken 08:00 am and again 2 hours before breaking the fast | Diagnostic test | Fasting group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 37051980Keskinler 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirac Vural Keskinler, MD principal investigator
IMU Doctoral program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type2 Diabetes, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04392570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.