Neoplasms

Symptoms and General Pathology

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Gland and Hormone Related Diseases

Rare Diseases

Neoplasm Metastasis

Adrenal Insufficiency

Neoplastic Processes

Adrenal Gland Diseases

Endocrine System Diseases

Secondary Adrenal Insufficiency

Vasoconstrictor Agents

Respiratory System Agents

All Drugs and Chemicals

Epinephrine

Glucocorticoids

Racepinephrine

Epinephryl borate

education of the patients (lifestyle) and adjustement of glucocorticoid replacement schedule

education and drug adjustement

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.

Intermittent fasting during the month of Ramadan is one of the five pillars of Islam and a sacred ritual for Muslims. Patients with chronic diseases seek advice from their physician and insist on fasting. A former study showed that 76.7% of adrenal insufficiency patients were exempted from fasting and 50.5% of them fasted against the advice of their physician. Few studies have assessed the risk of complications in adrenal insufficiency patients. The most frequently reported complications were asthenia (88.5%), signs suggestive of dehydration (49.2%), intense thirst (32.8%), and signs of hypoglycaemia (18%). Hypoglycaemia was detected by 24 hour-continuous glucose monitoring in 10% of fasting patients with secondary adrenal insufficiency (SAI). These complications were more frequent in patients with insufficient knowledge of the disease. A literature review was published 2021 and a risk stratification of patients with adrenal insufficiency and recommendations for patient education and therapeutic adjustment were proposed. However, no study has evaluated the effect of these measures on Ramadan fasting in SAI.

The objectives were to:

1. compare the number of fasted days and the prevalence of complications during Ramadan fasting before (2022) and after therapeutic education and treatment adjustment (2023) in patients with SAI.
2. determine the factors associated with complications during Ramadan fasting in SAI.

Methods:

Before the month of Ramadan 2023, patients meeting the inclusion criteria were enrolled. All patients signed a written informed consent.

During the first visit, the following data were recorded:

* gender, age, medical and surgical history, current treatments, medication schedule, the 2022 fast (number of fasted days, complications (type, days, time, break of the fast for a complication)).
* weight, height, lying and standing blood pressure.
* Some data were taken from the medical file: other affected pituitary axes, etiology of the SAI, results of the insulin hypoglycaemia test if performed (baseline cortisol, peak level, peak time, area under the curve), plasma creatinine.

Subsequently, patient education (the particularities of the disease, the risks and lifestyle measures) and therapeutic adjustments were performed according to the recommendations published by Chihaoui et al in Endocrine, 2021.

Throughout the month of Ramadan 2023, patients filled in forms indicating for the fasted days: dinner time, shour time, sleep time, unusual physical activity, treatment schedule, occurrence of complications: type, time, break of the fast for a complication.

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

before and after education and drug adjustement

Ramadan Fasting in Secondary Adrenal Insufficiency Patients

Data can be shared on reasonable request.

Hopital La Rabta

Professor

Immune System Diseases

Inflammation

Addison Disease

Autoimmune Diseases

Addison's Disease

Anti-Inflammatory Agents

Dermatologic Agents

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cortisone

Hydrocortisone-17-butyrate

Hormones

Hormone Antagonists

Plenadren (modified release hydrocortison) 20-25 or 30 mg oral tablets will be administered once-daily at 8.00 AM in the fasting state The dose is kept the same as patients had before entering the trial.

Hydrocortisone (dose range 10 to 30) mg will be continued as before entering the study. Cortisone Acetate (dose 25 to 37.5 mg) will be continued as before entering the study. The morning dose will be administered in the fasting state.

The total daily dose and timing is not changed during the study period.

Healthy volunteers will be enrolled as control group

Plenadren

Conventional glucocorticoid therapy

Andrea M Isidori, MD, PhD

This is a randomized, controlled, open, three-armed, multi-centre study designed to compare the effects of dual-release hydrocortisone preparations versus conventional glucocorticoid therapy on anthropometric parameters, metabolic syndrome, infectious, immunological profile, cardiovascular system, bone mass and quality of life in patients affected by primary or secondary adrenal insufficiency.

Hypocortisolism is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving conventional glucocorticoids therapy have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease, infectious, tumors and premature mortality that is more than twice the mortality rate in the background population. Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur.

In this trial a dual-release hydrocortisone preparations that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary and secondary adrenal insufficiency.

Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)

A Randomized, Controlled, Multi-Centre Trial on the Effects of Dual-release Hydrocortisone Preparations Versus Conventional Glucocorticoid Replacement Therapy in Patients Affected by Primary and Secondary Adrenal Insufficiency. DREAM Trial.

Single outcome measurement of body weight (kg).

Composite outcome measure consisting of simultaneous measurment of: Glycaemia, Insulinemia, Homa index, Glycated Haemoglobin, Total Cholesterol, LDL cholesterol, HDL cholesterol, Triglyceredes; the composite outcome measured at 3 and 6 months.

Composite outcome measure consisting of simultaneous measurment of: Full Count Blood Cell, ESR, Fibrinogen, Immunoglobulin, PCR; measured at baseline, 3 and 6 months.

Composite outcome measure consisting of simultaneous measurment of: serum calcium, phosphate, parathyroid hormone (PTH), 25OH-vitamin D, phosphate, osteocalcin, bone phosphate alkaline (sBALP), serum-cross-linked N and C-telopeptide of bone type I collagen (NTx- CTx); measure at baseline and 6 months.

Measurement of epicardial fat thickness (EFT) by hihg-resolution M-B-mode transthoracic echocardiography from baseline at 6 months.

Evaluation of hepatic steatosis by conventional ultrasound of the liver and with ASQ software with dedicated equipment and 7-5 Mhz convex probe frome baseline at 6 months.

Quality of life will be measured by questionnaires: AddiQol, Middle Sex Hospital Questionnaire (MHQ), International Index of Erectile Function (IIEF), Female Sexual Function Index (FSFI), Beck Depression Inventory Test (BDI-II).

Bone mineral density quantified by Dual X-Ray Absorptiometry (DEXA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ramadan Fasting in Secondary Adrenal Insufficiency Patients	NCT05827965	Secondary Adren... Fasting, Interm...	education and d...	18 Years -	Hopital La Rabta
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)	NCT02277587	Primary Adrenal... Secondary Adren...	Plenadren Conventional gl...	18 Years - 80 Years	University of Roma La Sapienza
Dual RElease Hydrocortisone Versus conventionAl Glucocorticoid replaceMent Therapy in Hypocortisolism (DREAM)	NCT02277587	Primary Adrenal... Secondary Adren...	Plenadren Conventional gl...	18 Years - 80 Years	University of Roma La Sapienza

Spots Global Cancer Trial Database for secondary adrenal insufficiency