Ramadan Fasting Outcomes in Patients With Secondary Adrenal Insufficiency Before and After the Treatment of Hypotension.

NCT ID: NCT06832566

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-15
• Study Completion Date: 2025-04-15

Brief Summary

Intermittent fasting in patients with adrenal insufficiency is associated with an increased risk of complications, such as dehydration. A recent study showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting. So, we are planning to carry out this prospective interventional study in patients with SAI and hypotension to evaluate the effect of treating hypotension with fludrocortisone on the risk of complications during fasting. Patients with secondary adrenal insufficiency and hypotension and who are willing to fast during Ramadan 2025 will be included. Before Ramadan, they will be treated with fludrocortisone at a dose of 50micg/day. The occurrence of complications and the number of fasted days during Ramadan 2025 will be reported and compared with those of Ramadan 2023.

Detailed Description

Intermittent fasting during Ramadan is practised by more than one billion people worldwide. Patients with adrenal insufficiency are at risk of complications during fasting. The most frequently reported complications were intense asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%) Chihaoui M, et al, Endocrine 2017;55:289-295. https://doi.org/10.1007/s12020-016-1186-0). A recent study showed that lifestyle measures and drug adjustment enabled more patients to fast and reduced the frequency of complications. It also showed that nearly half the patients had hypotension before the fasting month and half had signs of dehydration during fasting (ClinicalTrials.gov ID: NCT05827965 ; Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688).

The objective of the study is to compare the number of fasted days and the prevalence of complications during Ramadan fasting in patients with SAI before (2023) and after the treatment of hypotension with fludrocortisone (2025).

Keywords: secondary adrenal insufficiency; intermittent fasting; complications; hypotension; fludrocortisone; quality of life

Type of study: Prospective, interventional, before/after study

Study population:

The study will include patients with SAI and hypotension who participated in our former study in 2023 (ClinicalTrials.gov ID: NCT05827965 ; Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688). Patients will be included before the month of Ramadan, from February 15th to February 25th, 2025, according to the following selection criteria:

Inclusion criteria:

• Patients aged over 18 years
• Secondary adrenal insufficiency patients
• Substituted with glucocorticoids for more than one year.
• Participated in the former study in 2023.
• Willing to fast during the month of Ramadan 2025.

Exclusion criteria: cardiac, respiratory, hepatic or renal insufficiency (creatinine clearance < 60 ml/min/1.73m2), advanced neoplasia, undernutrition, diabetes insipidus, diabetes mellitus, neuro-psychiatric disease, infectious or chronic inflammatory disease, hyperthyroidism, uncontrolled hypothyroidism, alcoholism, diuretic intake, glucocorticoid treatment for purposes other than substitution, enzyme inducers, pregnancy, breastfeeding, consent withdrawn, study discontinuation.

Study period: February 15th -April 15th. Ramadan starts on March 1st and ends on March 29th, 2025.

Methods Before Ramadan 2025, patients meeting the inclusion criteria will be enrolled. All patients have to sign a written informed consent.

During the first visit (two weeks before Ramadan), the following data will be recorded:

• gender, age, medical and surgical history, current treatments, medication schedule,
• Physical examination data: weight, height, lying and standing blood pressure.
• Some data will be taken from the medical file: other affected pituitary axes, etiology of the SAI, baseline cortisol, and plasma creatinine.
• Data about 2023 fast (number of fasted days, complications (type, days, time, breaking of the fast (yes/no) will collected from our former study.

Fludocortisone at a dose of 50 micg/day will be added to the treatment of the patients.

During the second visit (one week before Ramadan), the quality of life questionnaire (AddiQoL) will be administered to the patients, blood pressure will be measured, and a blood sample will be collected for the measurement of sodium, potassium and urea.

Throughout Ramadan 2025, patients will have to fill in forms indicating the fasted days and the occurrence of complications (type, time, and break of the fast). Patients will be asked to respond to the AddiQoL questionnaire again during the third week of Ramadan.

Throughout the study, regular telephone contact with one of the investigators will be maintained for any additional information, advice or therapeutic adjustment.

After Ramadan, filled addiQoL questionnaires and forms will be collected.

Conditions

Secondary Adrenal Insufficiency; Hypotension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/d

Patients with secondary adrenal insufficiency and hypotension treated with fludrocortisone 0.05mg/day during Ramadan fasting 2025.

Group Type: EXPERIMENTAL

Fludrocortisone 0.1 Milligrams (mg)

Intervention Type: DRUG

Treatment of hypotension with fludrocortisone 0.05mg/day in patients with secondary adrenal insufficiency before Ramadan fasting. Outcomes (number of fasted days and complications during fasting) will be compared between Ramadan fasting 2025 (with fludrocortisone) and Ramadan 2023 (without fludrocortisone).

Interventions

Fludrocortisone 0.1 Milligrams (mg)

Treatment of hypotension with fludrocortisone 0.05mg/day in patients with secondary adrenal insufficiency before Ramadan fasting. Outcomes (number of fasted days and complications during fasting) will be compared between Ramadan fasting 2025 (with fludrocortisone) and Ramadan 2023 (without fludrocortisone).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged over 18 years
• Secondary adrenal insufficiency patients
• Substituted with glucocorticoids for more than one year.
• Participated in the former study in 2023.
• Willing to fast during the month of Ramadan 2025.

Exclusion Criteria

• cardiac, respiratory, hepatic or renal insufficiency (creatinine clearance < 60 ml/min/1.73m2), advanced neoplasia, undernutrition, diabetes insipidus, diabetes mellitus, neuro-psychiatric disease, infectious or chronic inflammatory disease, hyperthyroidism, uncontrolled hypothyroidism, alcoholism, diuretic intake, glucocorticoid treatment for purposes other than substitution, enzyme inducers, pregnancy, breastfeeding.
• consent withdrawn, study discontinuation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hopital La Rabta

OTHER

Sponsor Role: lead

Responsible Party

Melika Chihaoui

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hopital La Rabta

Tunis, Tunisia, Tunisia

Countries

Tunisia

Central Contacts

Melika Chihaoui, Professor

Role: CONTACT

melika.chihaoui@fmt.utm.tn

+21698647327

Facility Contacts

Melika Chihaoui, Professor

Role: primary

melikachihaoui@yahoo.fr

+21671150832

References

Chihaoui et al, Nutrition, 2025; https://doi.org/10.1016/j.nut.2025.112688

Reference Type: BACKGROUND

Other Identifiers

LaRabtaEndocrine1/2025

Identifier Type: -

Identifier Source: org_study_id