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

NCT06832566 | Not Yet Recruiting Phase 4

• 1 other identifier: LaRabtaEndocrine1/2025
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Adrenal Insufficiency; Hypotension

Keywords

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

Outcome Measures

Primary Outcomes (1)

• number of fasted days

  Total days fasted during the month of Ramadan 2025

  One month

Secondary Outcomes (1)

• complications during fasting

  One month

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Fludrocortisone 0.1 Milligrams (mg)

Interventions

Fludrocortisone 0.1 Milligrams (mg) 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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital La Rabta: lead

Study Sites (1)

Hopital La Rabta

Tunis, Tunisia, 1007, Tunisia

Location

Related Publications (1)

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

  BACKGROUND

MeSH Terms

Conditions

Hypotension; Intermittent Fasting

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Fasting; Feeding Behavior; Behavior

Central Study Contacts

Melika Chihaoui, Professor

CONTACT

+21698647327; melika.chihaoui@fmt.utm.tn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, interventional, before/after study

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 18, 2025
• Study Start: February 15, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

TU (1)