Fasting, Intermittent Clinical Trial
Official title:
Ramadan Fasting in Secondary Adrenal Insufficiency Patients
Verified date | February 2024 |
Source | Hopital La Rabta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 63 |
Est. completion date | March 1, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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for purposes other than substitution, - treatment with enzyme inducers, - pregnancy, - breastfeeding - consent withdrawn - study discontinuation. |
Country | Name | City | State |
---|---|---|---|
Tunisia | University Hospital La Rabta | Tunis |
Lead Sponsor | Collaborator |
---|---|
Hopital La Rabta |
Tunisia,
Chihaoui M, Chaker F, Yazidi M, Grira W, Ben Amor Z, Rejeb O, Slimane H. Ramadan fasting in patients with adrenal insufficiency. Endocrine. 2017 Jan;55(1):289-295. doi: 10.1007/s12020-016-1186-0. Epub 2016 Nov 23. — View Citation
Chihaoui M, Grira W, Bettaieb J, Yazidi M, Chaker F, Rejeb O, Oueslati I, Feki M, Kaabachi N, Slimane H. The risk for hypoglycemia during Ramadan fasting in patients with adrenal insufficiency. Nutrition. 2018 Jan;45:99-103. doi: 10.1016/j.nut.2017.07.014. Epub 2017 Aug 3. — View Citation
Chihaoui M, Mimita W, Oueslati I, Rejeb O, Ben Amor Z, Grira W, Yazidi M, Chaker F. Prednisolone or hydrocortisone replacement in patients with corticotrope deficiency fasting during Ramadan result in similar risks of complications and quality of life: a randomized double-blind controlled trial. Endocrine. 2020 Jan;67(1):155-160. doi: 10.1007/s12020-019-02082-w. Epub 2019 Sep 24. — View Citation
Chihaoui M, Yazidi M, Oueslati I, Khessairi N, Chaker F. Intermittent fasting in adrenal insufficiency patients: a review and guidelines for practice. Endocrine. 2021 Oct;74(1):11-19. doi: 10.1007/s12020-021-02804-z. Epub 2021 Jul 2. — View Citation
Hussain S, Hussain S, Mohammed R, Meeran K, Ghouri N. Fasting with adrenal insufficiency: Practical guidance for healthcare professionals managing patients on steroids during Ramadan. Clin Endocrinol (Oxf). 2020 Aug;93(2):87-96. doi: 10.1111/cen.14250. Epub 2020 Jun 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | number of fasted days | change in the number of fasted days | one month | |
Primary | prevalence of complications | change in the prevalece of complications | one month |
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