Type 2 DiabetesRandomizedNCT07384728
Ramadan Experience of Individuals With Type 2 Diabetes
A study testing The effect of fasting and not fasting during Ramadan. in people with Type 2 Diabetes, run by Dilan aktepe coşar at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to examine the effects of fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with type 2 diabetes. While Ramadan fasting is a religious practice, it can also pose health risks such as hypoglycemia, hyperglycemia, and metabolic imbalance in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- The effect of fasting and not fasting during Ramadan.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 3 Jan 2026to 20 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals ≥18 years of age
- Able to give informed consent
- Diagnosed with type 2 diabetes
- Planning to fast during Ramadan
Who cannot join
- Presence of psychiatric illness
- Presence of cognitive impairment
- Receiving additional treatments that significantly affect glucose levels (e.g., ongoing steroid therapy)
- Individuals who have decided not to fast during Ramadan
- Individuals who have stopped fasting during Ramadan
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Gümüşhane Universıty
Gümüşhane, Kelkit, 2900
Gümüşhane Üniversitesi
Gümüşhane, Kelkit, 29100
About this study
Official title: The Impact of Ramadan Experiences on Treatment, Psychological and Glycemic Control Levels, and Adherence in Individuals With Type 2 Diabetes
This study aims to examine the effects of fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with type 2 diabetes. While Ramadan fasting is a religious practice, it can also pose health risks such as hypoglycemia, hyperglycemia, and metabolic imbalance in individuals with diabetes. Adherence to treatment and self-care, as well as psychosocial adjustment, are crucial in the effective management of diabetes. Given that a large portion of Turkey's population is Muslim, comparing individuals with type 2 diabetes who fast and those who do not during Ramadan will contribute to improving patient care within a cultural and religious context. The findings of this study are expected to guide nurses in developing personalized, culturally sensitive care plans tailored to the needs of individuals before, during, and after Ramadan.
Read the detailed description
Fasting during Ramadan is a religious practice observed globally by adult Muslims. Individuals fast during Ramadan due to an emotional and spiritual connection to the holy month. Fasting involves abstaining from food, drink, and oral medications for a month, between sunrise and sunset each year. The duration of Ramadan fasting varies between 10 and 19 hours depending on geographical and seasonal conditions. While this is a religious practice, those who fast may experience various health risks, particularly for individuals with type 1 and type 2 diabetes.
Diabetes mellitus is an insidious chronic metabolic disease characterized by high blood sugar levels that cause serious damage to all body systems over time. Diabetes is a chronic disease that has increased in recent years and leads to morbidity, loss of productivity, decreased quality of life, and mortality in individuals due to various complications. Adherence to treatment plays a critical role in the treatment, care, and management of chronic diseases.
According to the WHO, adherence to treatment in diabetic patients is defined as a self-care process that includes home blood sugar monitoring, regulation of food consumption, medication use, regular physical activity, foot care, regular visits to the doctor for periodic check-ups, and dental care. Individuals who adhere to treatment in chronic diseases can exhibit effective coping skills, avoid psychological problems, experience fewer negative emotions, implement healthy lifestyle changes, and maintain control over their health status.
The psychological aspect of chronic diseases is often underestimated. Although it is assumed that most patients adapt well to the psychological aspects of chronic diseases, it becomes more difficult to adapt psychologically when patients experience deficiencies in their physical health status. Diabetes is a chronic disease that leads to mental and cognitive problems in addition to physiological complications, and it takes time to cope with it. Therefore, understanding the psychosocial adaptation to the disease in individuals with diabetes will guide nurses in positively influencing disease management and preventing or delaying possible complications. In addition, fasting negatively affects individuals with diabetes physically, socially, and psychologically. Glycemic control before Ramadan is considered a key determinant of fasting safety in individuals with diabetes.
In light of this information, and given that the Turkish population is predominantly Muslim, this study aims to examine the effects of fasting and non-fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with Type 2 diabetes. The results of this study are expected to guide healthcare professionals, particularly nurses who have the most contact with patients, in understanding cultural and religious practices before, during, and after Ramadan to provide personalized care tailored to patients' needs. Through this study, we aimed to identify effective strategies to improve both treatment adherence and psychological adjustment by positively impacting the treatment, care, and management of diabetic patients
- Conditions
- Type 2 Diabetes
- Being tested
- The effect of fasting and not fasting during Ramadan.
- Keywords
- Type 2 diabetes, Ramadan experience, Treatment, Psychological, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The effect of fasting and not fasting during Ramadan.Other
Also called The effect of fasting during Ramadan
The effects of fasting and non-fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Individuals observing the fast. | Experimental | Patients in the experimental group received face-to-face dietary education from the researcher in the waiting room for approximately 15 minutes, and were given an "Information Brochure." Pre-education (pre-test) data collection tools were administered to diabetic patients. All data collection tools were administered to these patients, except for the structured Patient Information Form, which was completed one month after Ramadan 2026. Receives: Other: The effect of fasting and not fasting during Ramadan. |
| No Intervention: Control Group | No intervention | Diabetic patients in this group were classified as a non-fasting group. No intervention was applied. Only data collection forms were administered before the study (pre-test) and after Ramadan 2026. |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Parametre
HbA1c 2-4 weeks before Ramadan (basic assessment).
Measured: 2-4 weeks
2. Parametre
Treatment Adherence Scale, 2-4 weeks before Ramadan This scale was developed to evaluate "Patient Adherence in Type 2 Diabetes Mellitus Treatment." Validity and reliability analyses have shown it to be a valid and reliable scale. Based on the scores obtained from the scale, adherence is considered good if patients are doing what they should and not doing what they shouldn't, despite factors affecting treatment adherence.
The scale:
- Is administered to patients with type 2 diabetes for at least one year. • Consists of 30 items in total.
- A 5-point Likert scale is used for scoring. • Patients indicate the most appropriate option for each statement on the scale using a 5-point Likert scale (Strongly agree=1, Agree=2, Partially agree=3, Disagree=4, and Strongly disagree=5). • The scale contains 13 items representing positive attitudes and 17 items representing negative attitudes. In scoring, positive items (1, 3, 5, 8, 13, 15, 16, 17, 19, 23, 25, 26, 29) are scor
Measured: 2-4 weeks
3. Parametre
Psychological and Adherence Impact Scale 2-4 weeks before Ramadan. The BASE-6 was developed by Cruz et al. (2019) and it is a self-report instrument of general psychological adjustment comprising of six items. Each item assesses how a participant has been feeling in the past week. Items are rated on a 7-point scale (ranging from 1 = Not at all to 5 = Extremely).
A sample item is "To what extent have you felt irritable, angry, and/or resentful this week?". Using three different adult samples, the original study demonstrated good internal consistency (α = .87-.93) and test-retest reliability (intraclass correlation was .77) over one-week period.
Measured: 2-4 weeks
Post-Ramadan 2. Parametre
Treatment adherence will be assessed using the Treatment Adherence Scale for Type 2 Diabetes Mellitus, a validated and reliable 30-item, 5-point Likert scale. Patients rate each item from strongly agree to strongly disagree. Higher scores indicate better adherence to diabetes treatment.
Measured: Post-Ramadan: 1-2 months after
Secondary outcomes (2)
Post-Ramadan 1. Parametre
Post-Ramadan: 1-2 months after the end of fasting (follow-up). Measurements: HbA1c
Measured: Post-Ramadan: 1-2 months after
Post-Ramadan 3. Parametre
Post-Ramadan: 1-2 months after the end of fasting (follow-up). Measurements: The BASE-6 was developed by Cruz et al. (2019) and it is a self-report instrument of general psychological adjustment comprising of six items. Each item assesses how a participant has been feeling in the past week. Items are rated on a 7-point scale (ranging from 1 = Not at all to 5 = Extremely).
A sample item is "To what extent have you felt irritable, angry, and/or resentful this week?". Using three different adult samples, the original study demonstrated good internal consistency (α = .87-.93) and test-retest reliability (intraclass correlation was .77) over one-week period.
Measured: Post-Ramadan: 1-2 months after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2026
- Study start3 Jan 2026 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a clinical trial designed to examine the effects of fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with type 2 diabetes. The study compares individuals who fast and those who do not fast during Ramadan to evaluate the relevant variables. Participants are monitored before and after Ramadan; glycemic control, treatment adherence, and psychological adjustment are measured using standardized measurement tools. The study model aims to guide clinical practice and nursing care with the results obtained.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dilan aktepe coşar
- Sponsor type
- University, hospital or other
- Collaborators
- Gümüşhane Universıty
- Responsible party
- Sponsor-investigator, Dilan aktepe coşar, Gümüşhane Universıty
- Investigators
- Dilan aktepe coşar, PhD, Study director, Gümüşhane Universıty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384728
- Sponsor's protocol ID
- Hm20260001
- Acronym
- Randomized
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared due to the need to protect participant confidentiality, the privacy of personal health information, and compliance with applicable ethical committee approval and data protection legislation (KVKK). Data will only be analyzed for scientific purposes in an anonymized and aggregated form, and there are no plans to share raw data containing individually identifying information with third parties. This approach has been adopted to protect participant rights and ensure compliance with ethical research principles.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Ramadan Experiences on Treatment, Psychological and Glycemic Control Levels, and Adherence in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07384728
- Acronym / sponsor ID
- Randomized / Hm20260001
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Ramadan experience, Treatment, Psychological, Glycemic control
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Dilan aktepe coşarUniversity, hospital or other
- Collaborators
- Gümüşhane Universıty
- Study start
- 3 Jan 2026 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Mar 2026 (estimated)
- First posted
- 3 Feb 2026 (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.
This study aims to examine the effects of fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with type 2 diabetes. While Ramadan fasting is a religious practice, it can also pose health risks such as hypoglycemia, hyperglycemia, and metabolic imbalance in individuals with diabetes. Adherence to treatment and self-care, as well as psychosocial adjustment, are crucial in the effective management of diabetes. Given that a large portion of Turkey's population is Muslim, comparing individuals with type 2 diabetes who fast and those who do not during Ramadan will contribute to improving patient care within a cultural and religious context. The findings of this study are expected to guide nurses in developing personalized, culturally sensitive care plans tailored to the needs of individuals before, during, and after Ramadan.
Detailed description
Fasting during Ramadan is a religious practice observed globally by adult Muslims. Individuals fast during Ramadan due to an emotional and spiritual connection to the holy month. Fasting involves abstaining from food, drink, and oral medications for a month, between sunrise and sunset each year. The duration of Ramadan fasting varies between 10 and 19 hours depending on geographical and seasonal conditions. While this is a religious practice, those who fast may experience various health risks, particularly for individuals with type 1 and type 2 diabetes.
Diabetes mellitus is an insidious chronic metabolic disease characterized by high blood sugar levels that cause serious damage to all body systems over time. Diabetes is a chronic disease that has increased in recent years and leads to morbidity, loss of productivity, decreased quality of life, and mortality in individuals due to various complications. Adherence to treatment plays a critical role in the treatment, care, and management of chronic diseases.
According to the WHO, adherence to treatment in diabetic patients is defined as a self-care process that includes home blood sugar monitoring, regulation of food consumption, medication use, regular physical activity, foot care, regular visits to the doctor for periodic check-ups, and dental care. Individuals who adhere to treatment in chronic diseases can exhibit effective coping skills, avoid psychological problems, experience fewer negative emotions, implement healthy lifestyle changes, and maintain control over their health status.
The psychological aspect of chronic diseases is often underestimated. Although it is assumed that most patients adapt well to the psychological aspects of chronic diseases, it becomes more difficult to adapt psychologically when patients experience deficiencies in their physical health status. Diabetes is a chronic disease that leads to mental and cognitive problems in addition to physiological complications, and it takes time to cope with it. Therefore, understanding the psychosocial adaptation to the disease in individuals with diabetes will guide nurses in positively influencing disease management and preventing or delaying possible complications. In addition, fasting negatively affects individuals with diabetes physically, socially, and psychologically. Glycemic control before Ramadan is considered a key determinant of fasting safety in individuals with diabetes.
In light of this information, and given that the Turkish population is predominantly Muslim, this study aims to examine the effects of fasting and non-fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with Type 2 diabetes. The results of this study are expected to guide healthcare professionals, particularly nurses who have the most contact with patients, in understanding cultural and religious practices before, during, and after Ramadan to provide personalized care tailored to patients' needs. Through this study, we aimed to identify effective strategies to improve both treatment adherence and psychological adjustment by positively impacting the treatment, care, and management of diabetic patients
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This research is a clinical trial designed to examine the effects of fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control in individuals with type 2 diabetes. The study compares individuals who fast and those who do not fast during Ramadan to evaluate the relevant variables. Participants are monitored before and after Ramadan; glycemic control, treatment adherence, and psychological adjustment are measured using standardized measurement tools. The study model aims to guide clinical practice and nursing care with the results obtained.
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Individuals observing the fast. | Experimental | Other: The effect of fasting and not fasting during Ramadan.Patients in the experimental group received face-to-face dietary education from the researcher in the waiting room for approximately 15 minutes, and were given an "Information Brochure." Pre-education (pre-test) data collection tools were administered to diabetic patients. All data collection tools were administered to these patients, except for the structured Patient Information Form, which was completed one month after Ramadan 2026. |
| No Intervention: Control Group | No intervention | –Diabetic patients in this group were classified as a non-fasting group. No intervention was applied. Only data collection forms were administered before the study (pre-test) and after Ramadan 2026. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals ≥18 years of age
- Able to give informed consent
- Diagnosed with type 2 diabetes
- Planning to fast during Ramadan
Key exclusion criteria (5 listed)
- Presence of psychiatric illness
- Presence of cognitive impairment
- Receiving additional treatments that significantly affect glucose levels (e.g., ongoing steroid therapy)
- Individuals who have decided not to fast during Ramadan
- Individuals who have stopped fasting during Ramadan
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 |
|---|---|---|
| The effect of fasting and not fasting during Ramadan.Also: The effect of fasting during RamadanThe effects of fasting and non-fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control. | Other | Experimental group: Individuals observing the fast. |
Primary outcome
1. Parametre
Time frame: 2-4 weeks
HbA1c 2-4 weeks before Ramadan (basic assessment).
2. Parametre
Time frame: 2-4 weeks
Treatment Adherence Scale, 2-4 weeks before Ramadan This scale was developed to evaluate "Patient Adherence in Type 2 Diabetes Mellitus Treatment." Validity and reliability analyses have shown it to be a valid and reliable scale. Based on the scores obtained from the scale, adherence is considered good if patients are doing what they should and not doing what they shouldn't, despite factors affecting treatment adherence. The scale: * Is administered to patients with type 2 diabetes for at least one year. • Consists of 30 items in total. * A 5-point Likert scale is used for scoring. • Patients indicate the most appropriate option for each statement on the scale using a 5-point Likert scale (Strongly agree=1, Agree=2, Partially agree=3, Disagree=4, and Strongly disagree=5). • The scale contains 13 items representing positive attitudes and 17 items representing negative attitudes. In scoring, positive items (1, 3, 5, 8, 13, 15, 16, 17, 19, 23, 25, 26, 29) are scor
3. Parametre
Time frame: 2-4 weeks
Psychological and Adherence Impact Scale 2-4 weeks before Ramadan. The BASE-6 was developed by Cruz et al. (2019) and it is a self-report instrument of general psychological adjustment comprising of six items. Each item assesses how a participant has been feeling in the past week. Items are rated on a 7-point scale (ranging from 1 = Not at all to 5 = Extremely). A sample item is "To what extent have you felt irritable, angry, and/or resentful this week?". Using three different adult samples, the original study demonstrated good internal consistency (α = .87-.93) and test-retest reliability (intraclass correlation was .77) over one-week period.
Post-Ramadan 2. Parametre
Time frame: Post-Ramadan: 1-2 months after
Treatment adherence will be assessed using the Treatment Adherence Scale for Type 2 Diabetes Mellitus, a validated and reliable 30-item, 5-point Likert scale. Patients rate each item from strongly agree to strongly disagree. Higher scores indicate better adherence to diabetes treatment.
2 secondary outcomes
Post-Ramadan 1. Parametre
Time frame: Post-Ramadan: 1-2 months after
Post-Ramadan 3. Parametre
Time frame: Post-Ramadan: 1-2 months after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No. Individual patient data will not be shared due to the need to protect participant confidentiality, the privacy of personal health information, and compliance with applicable ethical committee approval and data protection legislation (KVKK). Data will only be analyzed for scientific purposes in an anonymized and aggregated form, and there are no plans to share raw data containing individually identifying information with third parties. This approach has been adopted to protect participant rights and ensure compliance with ethical research principles.
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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.
Dilan aktepe coşar, PhD study director
Gümüşhane Universıty
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The effect of fasting and not fasting during Ramadan. in people with Type 2 Diabetes, run by Dilan aktepe coşar at 2 sites 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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dilan aktepe coşar, PhD (+905075935875 ext. 4149, dilan_aktepe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Parametre (time frame: 2-4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026.