Adrenal Insufficiency, Congenital Clinical Trial
— GLYSUROfficial title:
Prevalence of Hypoglycaemia in Congenital Adrenal Insufficiency
| Verified date | January 2023 |
| Source | Assistance Publique - Hôpitaux de Paris |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 9 |
| Est. completion date | August 31, 2022 |
| Est. primary completion date | August 31, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Months to 6 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Necker-Enfants Malades | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevalence of hypoglycaemia | 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). | 1 year | |
| Secondary | Duration of hypoglycaemia | Time in hypoglycaemia measured in minutes per day during the continuous blood glucose measurements. | 1 year | |
| Secondary | Percentage of time in hypoglycaemia | Percentage of time in hypoglycaemia during the continuous blood glucose measurements. | 1 year | |
| Secondary | Glycemic variations rate | 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. | 1 year | |
| Secondary | Circumstances of occurrence of hypoglycaemia | Circumstances in which hypoglycaemia occurred : descriptive data by parents, symptomatic or not symptomatic hypoglycaemia, descriptive signs if they are presents. | 1 year | |
| Secondary | Occurrence of medical events | 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). | 1 year | |
| Secondary | Body Mass Index | Body mass divided by the square of the body height expressed in units of kg/m2 : mass in kilograms and height in meters | 1 year | |
| Secondary | Systolic and Diastolic Blood Pressure | Expressed millimetre of mercury | 1 year | |
| Secondary | Heart rate | Number of beats per minute | 1 year | |
| Secondary | Stade tanner | stade tanner A1 to A5 | 1 year | |
| Secondary | Amount of salt consumed per day | Number of grams per day | 1 year | |
| Secondary | Cortisol at 8 a.m. | microgram / deciliter | 1 year | |
| Secondary | Cycle of 17-hydroxyprogesterone | Nanomole per liter | 1 year | |
| Secondary | Adreno CorticoTropic Hormone | Nanogram per liter | 1 year | |
| Secondary | 17-hydroxyprogesterone | Nanomole per liter | 1 year | |
| Secondary | Delta-4-Androstenedione | Nanomole per liter | 1 year | |
| Secondary | Testosterone | Nanomole per liter | 1 year | |
| Secondary | Ionogram | Nanomole per liter | 1 year | |
| Secondary | Renin | picogram/milliliter | 1 year |