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

January 16, 2026 updated by: Melika Chihaoui, Hopital La Rabta
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The risk of hypoglycemia in adrenal insufficiency is known but poorly studied. It is due to cortisol deficiency. Only a few publications have addressed this topic. The risk of hypoglycemia is thought to be increased during acute decompensation, following treatment discontinuation, and during fasting or delayed eating. Thus, this risk is thought to be increased during intermittent fasting, such as the Ramadan fast. A previous study conducted in the endocrinology department of La Rabta Hospital, involving 30 subjects with corticotropic insufficiency who underwent 24-hour continuous glucose monitoring (CGM), identified three cases of hypoglycemia during intermittent fasting and no hypoglycemia outside of fasting periods. A more recent study showed that the prevalence of hypoglycemia, assessed by a seven day-CGM, was 63% outside of fasting and 71% during Ramadan fasting in subjects with PAI substituted with hydrocortisone at the usual dose of 20mg/day.

The most commonly used glucocorticoid replacement therapy is based on hydrocortisone or cortisone. Prednisolone is also indicated, particularly in cases difficult to control with hydrocortisone. The usual dose is 5 mg/day. It has been suggested to replace hydrocortisone with prednisolone to reduce the risk of complications during Ramadan fasting. However, this has never been demonstrated. A previous study showed that the prevalence of complications, quality of life, and point-in-time capillary blood glucose measurements were not different with hydrocortisone or prednisolone.

On the other hand, the risk of dehydration and hypotension seems to be low in patients treated with hydrocortisone.

General objective:

To evaluate the risks of intermittent fasting in subjects with PAI treated with prednisolone 5 mg/day.

Specific objectives:

  • To evaluate the frequency of hypoglycemia in subjects with PAI treated with prednisolone 5 mg/day during and outside of Ramadan fasting.
  • To evaluate the frequency of dehydration in subjects with PAI treated with prednisolone 5 mg/day during and outside of Ramadan fasting.
  • To study the factors associated with hypoglycemia and dehydration.

Study type: prospective, interventional, with the subject serving as their own control.

Visit 1: 4 weeks before Ramadan

  • Verification of inclusion and exclusion criteria.
  • Explanation of the study objectives and procedures.
  • Obtaining informed consent from the patient.
  • Switching from hydrocortisone to prednisolone 5 mg/day. Fludrocortisone will be continued, and the dose will be adjusted if necessary.

Visit 2: 14 days before Ramadan, patients treated with prednisolone for 14 days.

This visit will include an interview, a physical examination, placement of a CGM system, and a fasting blood sample.

Interview:

  • Demographic data: age, sex
  • Data related to PAI: duration, etiology, replacement therapy. History of fasting and its duration (number of days fasted, occurrence of complications).
  • Quality of life questionnaire (AddiQoL) and sleep quality questionnaire (PSQI). Physical examination: weight, height, waist circumference, blood pressure (lying and standing), heart rate, presence of hyperpigmentation, signs of dehydration.

The CGM device, consisting of a subcutaneous sensor (2.5 mm flexible catheter) and a transmitter (single-use), will be inserted. This device measures and records interstitial glucose every three minutes for 14 days.

The CGM application will be downloaded to the patient's or a parent's smartphone for data collection and transmission.

  • Issuance of monitoring sheets. During the 14 days of CGM, patients will be required to complete a monitoring sheet including medication intake, wake-up and bedtimes, physical activity, and any adverse events (fatigue, signs of hypoglycemia, signs of hypotension, or other symptoms). Patients will be contacted by one of the investigators by telephone to ensure adherence to the protocol and to monitor for any potential complications.
  • Laboratory tests: urea, electrolytes.

Visit 3: During Ramadan (the first 14 days). This visit will include an interview, a physical examination, placement of the CGM device, and a fasting blood sample, following the same procedure as Visit 2.

  • The patient will receive dietary and lifestyle advice regarding fasting.
  • Monitoring forms will be provided. During this study period, patients will also be required to complete the same monitoring form. Patients will also be contacted by one of the investigators by telephone to verify adherence to the protocol and to monitor for any potential complications.

The criteria for breaking the fast are:

Occurrence of discomfort during fasting, hypoglycemia on MCG, elevated urea, or hyperkalemia.

Visit 4: After Ramadan, patients should submit their monitoring records.

Diagnostic criteria:

  • First-degree hypoglycemia is defined as an interstitial glucose level measured during continuous glucose monitoring (CGM) < 0.70 g/L for more than 15 minutes, and second-degree hypoglycemia as an interstitial glucose level < 0.55 g/L for more than 15 minutes.
  • Dehydration is defined by the onset of arterial hypotension (BP < 90/60 mmHg or orthostatic hypotension) or an elevation of plasma urea.

Statistical analysis:

The frequencies of hypoglycemia and dehydration will be calculated and compared between the fasting and non-fasting periods. Mean blood glucose levels per period (suhoor-5 a.m.; 5 a.m.-10 a.m.; more than 10 a.m. after suhoor) will also be calculated and compared between the fasting and non-fasting periods. Univariate and potentially multivariate analyses will be conducted to determine the factors associated with hypoglycemia and dehydration.

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Tunisia
      • Tunis, Tunisia
        • University Hospital La Rabta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Outside Ramadan fasting
Patients with PAI treated with prednisolone 5mg/day, outside Ramadan fasting
Experimental: Ramadan fasting
Patients with PAI treated with prednisolone 5mg/day during Ramadan fasting.
Other: Ramadan fasting
Ramadan fasting is a religious dry intermittent fasting
Other Names:
  • dry intermittent fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia
Time Frame: during 14 days before Ramdan fasting and 14 days of Ramdan fasting
Diagnosed using continuous glucose monitoring
during 14 days before Ramdan fasting and 14 days of Ramdan fasting
Dehydration
Time Frame: During the 14 days before Ramadan fasting and during the 14 days of Ramadan fasting.
Hypotension and increased serum urea
During the 14 days before Ramadan fasting and during the 14 days of Ramadan fasting.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital La Rabta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 22, 2026

Primary Completion (Estimated)

March 22, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

January 16, 2026

First Submitted That Met QC Criteria

January 16, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 26, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLaRabta26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

IPD can be shared with other researchers on a reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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