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NCT Number: NCT07384728

Ramadan Experience of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gümüşhane Universıty, Gümüşhane, Kelkit, Turkey (Türkiye)

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals ≥18 years of age

Able to give informed consent

Diagnosed with type 2 diabetes

Planning to fast during Ramadan

Exclusion criteria

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

Treatment and study plan

The effect of fasting and not fasting during Ramadan.

Other

The effects of fasting and non-fasting during Ramadan on treatment adherence, psychological adjustment, and glycemic control.

Other names: The effect of fasting during Ramadan

Primary outcomes

  1. 1. Parametre

    Time frame: 2-4 weeks

    HbA1c 2-4 weeks before Ramadan (basic assessment).

  2. 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. 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.

  4. 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.

Secondary outcomes

  1. Post-Ramadan 1. Parametre

    Time frame: Post-Ramadan: 1-2 months after

    Post-Ramadan: 1-2 months after the end of fasting (follow-up). Measurements: HbA1c

  2. Post-Ramadan 3. Parametre

    Time frame: Post-Ramadan: 1-2 months after

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dilan aktepe coşar, PhD

CONTACT

[email protected]

+905075935875 ext. 4149

Hatice Demirağ, PhD

CONTACT

[email protected]

05534267394 ext. 4445

Sponsors and collaborators

Lead sponsor

Dilan aktepe coşar

Other

Collaborators

  • Gümüşhane Universıty

Registry information

Official study title

The Impact of Ramadan Experiences on Treatment, Psychological and Glycemic Control Levels, and Adherence in Individuals With Type 2 Diabetes

Acronym: Randomized

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2026
Registry last updated
Feb 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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