Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency

February 12, 2025 updated by: Melika Chihaoui, Hopital La Rabta
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The risk of hypoglycaemia in primary adrenal insufficiency (PAI) is well known but has been only few studied. It is explained by cortisol insufficiency. Only a few publications concerned this subject. The risk of hypoglycaemia seems to be increased during acute decompensation, following cessation of treatment and during fasting or delayed food intake. So, this risk would be increased during intermittent fasting such as the Ramadan fast. A previous study carried out in the endocrinology department of La Rabta University Hospital involving 30 subjects with secondary adrenal insufficiency who were monitored by continuous glucose monitoring (CGM) for 24 hours showed three cases of hypoglycaemia during intermittent fasting and no hypoglycaemia outside fasting. Studies assessing the risks of intermittent fasting concerned subjects with secondary adrenal insufficiency. No study assessed the risks of intermittent fasting in PAI. Furthermore, given the mineralocorticoid deficiency in PAI, there is also a risk of dehydration and hypotension.

Aims of the study:

Overall objective: to assess the risks of intermittent fasting in subjects with primary adrenal insufficiency.

Specific objectives:

  • To assess the frequency of hypoglycaemia in subjects with primary adrenal insufficiency during fasting and outside fasting.
  • To assess the frequency of dehydration in subjects with primary adrenal insufficiency during fasting and outside fasting.
  • To study the factors associated with hypoglycaemia and dehydration.

Methods :

Type of study: prospective, cross over, comparative study with subjects taken as their own controls.

A group of 15 patients will be studied during the week preceding the month of Ramadan (non fasting week) and the first week of Ramadan (fasting week). A group of 15 patients will be studied during the fourth week of Ramadan (fasting week) and the first week after Ramadan (non fasting week). The analysis will thus concern 210 fasted days and 210 non-fasted days.

The included patients will be examined on two occasions 14 days apart. Visit 1 will include a clinical examination, the setting up of the continuous glucose monitoring system, a fasting blood sampling and the delivery of monitoring sheets.

Clinical data:

  • Demographic data: age, gender
  • Data relating to PAI: age, aetiology, replacement therapy. Fasting history and course (number of days fasted, occurrence of complications).
  • Quality of life and quality of sleep questionnaire.
  • weight, height, waist circumference, supine and standing blood pressure, heart rate, presence of melanoderma, signs of dehydration.

The patient will be given dietary and hygiene advice on fasting and the treatment (gluco- and mineral-corticosteroids) will be adjusted if necessary, in accordance with the recommendations published in 2021 and 2022.

Biological data: urea, iono

During the study period (two weeks), patients will be asked to fill in a monitoring form which will include details of medication taken, waking and bedtimes, physical activity and the occurrence of any discomfort (asthenia, signs of hypoglycaemia, signs of arterial hypotension or other).

Patients will be monitored during the fasting period by one of the investigators by telephone in order to check compliance with the protocol and the possible occurrence of complications.

Criteria for breaking the fasting: occurrence of malaise during fasting, hypoglycaemia diagnosed by CGM, elevation of urea or hyperkalaemia.

Visit 2 : the patients will undergo a clinical examination including quality of life and quality of sleep questionnaires and a physical examination, fasting blood sampling, recovery of the continuous glucose monitoring system and monitoring sheets.

Diagnosis criteria:

  • Hypoglycaemia is defined as interstitial glucose measured during CGM < 2.8mmol/l.
  • Dehydration is defined by the presence of arterial hypotension (BP <9/6cmHg or orthostatic hypotension) or elevated plasma urea.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • Tunisia
      • Tunis, Tunisia, 1007
        • Hopital 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:

  • 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.

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Non fasting
Non fasting arm: usual diet and behavior
Experimental: Fasting
Intermittent fasting
Behavioral: intermittent fasting
fasting from predawn to sunset (no eating and no drinking), for approximately 16 hours.
Other Names:
  • Ramadan fasting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoglycemia
Time Frame: the fasting period from predawn to sunset (approximately 16 hours)
clinical signs or interstitial glucose lower than 2.8mmol/l
the fasting period from predawn to sunset (approximately 16 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dehydration
Time Frame: the fasting period from predawn to sunset (approximately 16 hours)
clinical signs of dehydration or increase of plasmatic urea
the fasting period from predawn to sunset (approximately 16 hours)

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 (Actual)

March 4, 2024

Primary Completion (Actual)

April 20, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

March 5, 2024

First Posted (Actual)

March 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HLaRabta24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data can be shared upon reasonable request.

IPD Sharing Time Frame

after the publication

IPD Sharing Access Criteria

by mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

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.

Clinical Trials on Intermittent Fasting

Clinical Trials on intermittent fasting

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe