Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299020
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2024-02-28
Brief Title:
Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency
Sponsor:
Hopital La Rabta
Organization:
Hopital La Rabta
Study Overview
Official Title:
Risks of Intermittent Fasting in Patients With Primary Adrenal Insufficiency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 28mmoll
Dehydration is defined by the presence of arterial hypotension BP 96cmHg or orthostatic hypotension or elevated plasma urea
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 28mmoll
Dehydration is defined by the presence of arterial hypotension BP 96cmHg or orthostatic hypotension or elevated plasma urea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None