Intermittent Fasting Clinical Trial
Official title:
Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency
In primary adrenal insufficiency, there is an increased risk of hypoglycaemia and dehydration. These risks have been little studied particularly during intermittent fasting. The present study aimed to assess these risks in a prospective study of 30 subjects with primary adrenal insufficiency. Patients will undergo a clinical examination, blood sampling and continuous glucose monitoring for fourteen days (one week of fasting and one week of non-fasting).
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | December 2024 |
Est. primary completion date | April 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 65 Years |
Eligibility | Inclusion Criteria: - Primary adrenal insufficiency - Disease duration of at least one year - Substituted with hydrocortisone and fludrocortisone - Wishing to fast during the month of Ramadan 2024 Exclusion Criteria: - Diabetes mellitus - Renal insufficiency - Hepatic insufficiency - Cardiac insufficiency - Respiratory insufficiency - Use of hypoglycaemic agents - Use of diuretics - Use of glucocorticoids other than those prescribed for replacement - Poor control of the disease (asthenia, malaise, melanoderma, discontinuation of treatment, etc.) - Pregnancy - Breast-feeding. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Hopital La Rabta |
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 — 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. Ep — View Citation
Kawahara T, Tsuji M, Tominaga N, Toyama N, Toda M. Frequency of Adrenal Insufficiency in Patients With Hypoglycemia in an Emergency Department: A Cross-sectional Study. J Endocr Soc. 2022 Aug 4;6(10):bvac119. doi: 10.1210/jendso/bvac119. eCollection 2022 — View Citation
Lee SC, Baranowski ES, Sakremath R, Saraff V, Mohamed Z. Hypoglycaemia in adrenal insufficiency. Front Endocrinol (Lausanne). 2023 Nov 20;14:1198519. doi: 10.3389/fendo.2023.1198519. eCollection 2023. — View Citation
Watanabe T, Ozawa A, Ishii S, Tomaru T, Shibusawa N, Saito T, Yamada E, Horiguchi K, Nakajima Y, Matsumoto S, Yoshino S, Katano-Toki A, Hashimoto K, Mori M, Okada S, Satoh T, Yamada M. Usage of continuous glucose monitoring (CGM) for detecting an unrecogn — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | hypoglycemia | clinical signs or interstitial glucose lower than 2.8mmol/l | the fasting period from predawn to sunset (approximately 16 hours) | |
Secondary | Dehydration | clinical signs of dehydration or increase of plasmatic urea | the fasting period from predawn to sunset (approximately 16 hours) |
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