Risks of Ramadan Fasting in Patients With Primary Adrenal Insufficiency Treated With Prednisolone.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-70
SponsorHopital La Rabta

About this trial

In primary adrenal insufficiency (PAI), there is a risk of hypoglycemia and dehydration. These risks seem to be increased during intermittent fasting. A previous study in patients with PAI treated with hydrocortisone at a dose of 20 mg/day showed that the prevalence of hypoglycemia was as high outside (63%) as during Ramadan fasting (71%), and that there was no risk of dehydration. We propose to evaluate the risk of complications during and outside of Ramadan fasting through a prospective study with subjects taken as their own controls, in 35 patients with PAI treated with prednisolone at a dose of 5 mg/day. Patients will undergo an interview, physical examination, blood sampling, and continuous glucose monitoring (CGM) during two weeks of fasting and two weeks of non-fasting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

subjects with primary adrenal insufficiency known for at least one year, treated with a glucocorticoid and a mineralocorticoid, who wish to fast during Ramadan 2026.

Disqualifiers

presence of diabetes, renal, hepatic, cardiac, or respiratory insufficiency; use of hypoglycemic agents (sulfonylureas), diuretics, use of any glucocorticoid other than the prescribed replacement therapy; poor disease control (asthenia, malaise, hyperpigmentation, discontinuation of treatment, etc.); pregnancy; breastfeeding; menstruation.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Ramadan fasting

    Other intervention

    Ramadan fasting is a religious dry intermittent fasting

Treatment groups

35 Participants
are divided into 2 treatment groups
Group A: Outside Ramadan fastingNo intervention 0 interventions
Group B: Ramadan fastingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hypoglycemia

Diagnosed using continuous glucose monitoring

Time frame
during 14 days before Ramdan fasting and 14 days of Ramdan fasting
2

Dehydration

Hypotension and increased serum urea

Time frame
During the 14 days before Ramadan fasting and during the 14 days of Ramadan fasting.

Secondary outcomes

Other outcomes

Sponsors and contacts

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