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Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency (GLYSUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04322435
Recruitment Status : Not yet recruiting
First Posted : March 26, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is probably underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.

The objective of the study is to evaluate the prevalence of hypoglycaemia in children with adrenal insufficiency.


Condition or disease Intervention/treatment Phase
Adrenal Insufficiency, Congenital Other: Continuous blood glucose measurement Other: Measurement of capillary blood glucose Not Applicable

Detailed Description:

Children with congenital primary and secondary adrenal insufficiency, who are deficient in cortisol, are at risk for hypoglycaemia, irrespective of appropriate hydrocortisone treatment, which can lead to potentially serious neurological complications. Few series are described in pediatrics. The prevalence of hypoglycaemia is underestimated because it is often asymptomatic and capillary blood glucose monitoring is not always performed routinely.

The objective of the study is to evaluate the prevalence of hypoglycaemia in children with congenital adrenal insufficiency.

The study will follow for one year children from 6 months to 6 years, with central and peripheral adrenal insufficiency.

4 study times are planned with two measurement methods:

  • Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
  • Measurement of capillary blood glucose, in the morning on an empty stomach, every first week of each month for 12 months, with Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the test strips Accu-Chek performed.
  • Measurement of capillary glycaemia in case of suspicion of hypoglycaemia. Measure left free according to the judgment of the parents of the necessary character or not. With Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek performa strips.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023


Arm Intervention/treatment
Adrenal insufficiency
Patients followed in the paediatric endocrinology department of the Necker Hospital, with primary and secondary adrenal insufficiency, aged from 6 months to 6 years.
Other: Continuous blood glucose measurement
Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.

Other: Measurement of capillary blood glucose

Measurement of capillary blood glucose :

  • In the morning on an empty stomach, every first week of each month for 12 months.
  • In case of suspicion of hypoglycaemia (parental assessment). Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek Performa strips.




Primary Outcome Measures :
  1. Prevalence of hypoglycaemia [ Time Frame: 1 year ]
    Number of hypoglycaemic events. Hypoglycaemia will be defined by a glucose level measured at a glucose level of less than or equal to 0.55 g /L (3 mmol /L).


Secondary Outcome Measures :
  1. Duration of hypoglycaemia [ Time Frame: 1 year ]
    Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements.

  2. Percentage of time in hypoglycaemia [ Time Frame: 1 year ]
    Percentage of time in hypoglycaemia during the continuous blood glucose measurements.

  3. Glycemic variations rate [ Time Frame: 1 year ]
    Glycemic variations rate during the different measurements times: minimum rate, maximum rate, average, median. Each result will be expressed in g /L or in mmol /L. Each date will expressed by one day and for one week.

  4. Circumstances of occurrence of hypoglycaemia [ Time Frame: 1 year ]
    Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents.

  5. Occurrence of medical events [ Time Frame: 1 year ]
    Events during the follow-up of the study: modification of treatment of hydrocortisone and fludrocortisone, re-sugaring expressed in number of sugar cubes ( by sugar cube = 20 gr of sugar) or type of sweet food given to the child, hospitalizations ( type and reason for hospitalization, cause of the decompensation).

  6. Body Mass Index [ Time Frame: 1 year ]
    Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters

  7. Systolic and Diastolic Blood Pressure [ Time Frame: 1 year ]
    Expressed millimetre of mercury

  8. Heart rate [ Time Frame: 1 year ]
    Number of beats per minute

  9. Stade tanner [ Time Frame: 1 year ]
    stade tanner A1 to A5

  10. Amount of salt consumed per day [ Time Frame: 1 year ]
    Number of grams per day

  11. Cortisol at 8 a.m. [ Time Frame: 1 year ]
    microgram / deciliter

  12. Cycle of 17-hydroxyprogesterone [ Time Frame: 1 year ]
    Nanomole per liter

  13. Adreno CorticoTropic Hormone [ Time Frame: 1 year ]
    Nanogram per liter

  14. 17-hydroxyprogesterone [ Time Frame: 1 year ]
    Nanomole per liter

  15. Delta-4-Androstenedione [ Time Frame: 1 year ]
    Nanomole per liter

  16. Testosterone [ Time Frame: 1 year ]
    Nanomole per liter

  17. Ionogram [ Time Frame: 1 year ]
    Nanomole per liter

  18. Renin [ Time Frame: 1 year ]
    picogram/milliliter



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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All male and female patients, followed in the Paediatric Endocrinology Department at Necker Hospital, with congenital primary and secondary adrenal insufficiency.
  • Age between 6 months and 6 years.
  • Included in the social security system.
  • Parental consent and willingness to participate in this study: involves training and skills in the use of blood glucometers.

Exclusion Criteria:

  • Patients with acquired adrenal insufficiency.
  • Patients with type 1 or type 2 diabetes.
  • Patients with somatotropic deficiency associated with adrenal insufficiency.
  • Refusal or impossibility to perform the glycaemic measurements according to the procedure of the study.
  • Not covered by the social security system.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04322435


Contacts
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Contact: Dinane Samara-Boustani, MD +33 1 44 49 48 01 dinane.samara-boustani@aphp.fr
Contact: Hélène Morel +33 1 71 19 63 46 helene.morel@aphp.fr

Locations
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France
Hôpital Necker-Enfants Malades
Paris, France, 75015
Contact: Dinane Samara-Boustani, MD    +33 1 44 49 48 01    dinane.samara-boustani@aphp.fr   
Contact: Hélène Morel    +33 1 71 19 63 46    helene.morel@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Dinane Samara-Boustani, MD Assistance Publique - Hôpitaux de Paris
Study Director: Michel Polak, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04322435    
Other Study ID Numbers: APHP190910
ID RCB 2019-A02250-57 ( Other Identifier: ANSM )
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Congenital primary and secondary adrenal insufficiency
Cortisol deficiency
Hypoglycaemia
Children
Additional relevant MeSH terms:
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Hypoglycemia
Adrenal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases