CompletedNot Applicable

Ramadan Fasting in Secondary Adrenal Insufficiency Patients

Tunisia63 participantsStarted 2023-03-01

Plain-language summary

Intermittent Ramadan fasting was associated with a risk of complications in patients with adrenal insufficiency. A risk stratification with recommendations (lifestyle and drug adjustment) for fasting in these patients has been recently published. So, this prospective interventional study was carried out to evaluated these recommendations. Patients with secondary adrenal insufficiency and willing to fast Ramadan were included. Before Ramadan, patients underwent a clinical examination and were educated for lifestyle measures and the schedule of glucocorticoid replacement therapy was adjusted. The occurrence of complications and the number of fasted days during the month of Ramadan 2023 were reported and compared with those of Ramadan 2022.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged over 18 years * Secondary adrenal insufficiency patients * Substituted with glucocorticoids for more than one year. * Willing to fast during the month of Ramadan 2023 Exclusion Criteria: * cardiac insufficiency, * respiratory insufficiency, * hepatic insufficiency, * renal insufficiency (creatinine clearance \< 60 ml/min/1.73m2), * advanced neoplasia, * undernutrition, * diabetes insipidus, * diabetes mellitus, * neuro-psychiatric disease, * infectious disease * chronic inflammatory disease, * hyperthyroidism, * uncontrolled hypothyroidism, * alcoholism, * diuretic intake, * glucocorticoid treatment for purposes other than substitution, * treatment with enzyme inducers, * pregnancy, * breastfeeding * consent withdrawn * study discontinuation.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

number of fasted days

Timeframe: one month

prevalence of complications

Timeframe: one month

Trial details

NCT IDNCT05827965

SponsorHopital La Rabta

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Secondary Adrenal Insufficiency trials