Recruiting NA Severe Hypoglycemia

New treatment option for Severe Hypoglycemia

Official title Longitudinal Study of the GLUcagon REsponse to Hypoglycemia in Children and Adolescents With New-onset Type 1 DIAbetes

ClinicalTrials.gov ID: NCT06770621

What this study is testing

What it's testing: The GLUREDIA study investigates the counter-regulatory response (CRR) during hypoglycemia in children with type 1 diabetes (T1D). Hypoglycemia can lead to severe symptoms, but is normally counteracted by CRR, corresponding to the secretion of hormones to maintain normoglycemia.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 2 to 30. Healthy volunteers may be eligible.

You may be able to join if

WP1 :
De novo type 1 diabetic patient, as per ISPAD criteria;
Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.
Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of...
Patients aged between 2 and 30 years

You likely can't join if

Child under 2 years of age.
Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives...
Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD.
Hepatic, renal or adrenal insufficiency.

See the full eligibility criteria

Who can join

WP1 :
De novo type 1 diabetic patient, as per ISPAD criteria;
Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.
Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose...
Patients aged between 2 and 30 years
Minimum weight: 17 kg (for blood samples)
Male - female patients
Free, written and oral consent.

What rules you out

Child under 2 years of age.
Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD.
Hepatic, renal or adrenal insufficiency.
History of bone marrow transplantation.
History of diabetes after hemolytic-uremic syndrome.
Epileptic patient
Absence of anti-islet autoantibodies.
Dysmorphia with suspicion of underlying genetic syndrome.
Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments. WP2 :
Inclusion Criteria:
De novo type 1 diabetic patient, as per ISPAD criteria;
Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.
Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose...
Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
Patients aged between 2 years and 18 years (\<18 years).
Male - female patients
Free, written and oral consent.
Exclusion criteria:
Child under 2 years of age.
Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD.
Hepatic, renal or adrenal insufficiency.
History of bone marrow transplantation.
History of diabetes after hemolytic-uremic syndrome.
Absence of anti-islet autoantibodies.
Dysmorphia with suspected underlying genetic syndrome.
Participation in another study within the previous 3 months with administration of blood derivatives or potentially immunomodulatory treatments. WP3 :
Inclusion Criteria:
Adult older than 18 years.
Absence of blood marker of diabetes (Absence of antibodies, HbA1C \ 0.18 nmol/L, Fasting blood glucose \< 100 mg/dL, blood glucose at any time \< 200 mg/dL).
Be a first-degree relative with a patient being followed for diabetes (meeting ISPAD criteria).
Male - Female
Free written and oral consent
Exclusion criteria:
Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD.
Hepatic, renal or adrenal insufficiency.
History of bone marrow transplantation.
History of diabetes after hemolytic-uremic syndrome.
Ischemic cardiomyopathy
Pregnant participant
Epileptic patient WP4 :
Inclusion Criteria: Cohort of patients followed for cystic fibrosis:
Pediatric patient between 2 and 18 years of age.
Diagnosed with cystic fibrosis with impaired pancreatic endocrine function.
Presents glucose homeostasis disorders (regular hypo/hyper-glycemia).
Male - female patient
Free, written and oral consent Cohort of patients with (sub)total pancreatectomy:
Pediatric patients between 2 and 18 years of age.
Follow-up for total pancreatectomy or caudal pancreatectomy
Presents disorders of carbohydrate homeostasis (regular hypo-/hyper-glycemia)
Male - female patient
Free, written and oral consent
Exclusion criteria:
Child under 2 years of age.
Body weight less than 17 kg.
Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD.
Hepatic, renal or adrenal insufficiency.
History of bone marrow transplantation.
History of diabetes after hemolytic-uremic syndrome.
Dysmorphia with suspected underlying genetic syndrome.
Participation in another study within the last 3 months, with administration of blood derivatives or potentially immunomodulatory treatments. WP5 :
Inclusion Criteria:
Patient who has undergone insulin testing due to suspected growth hormone deficiency or adrenal insufficiency or hypopituitarism.
Patients between the ages of 2 years and 18 years (\<18 years).
Male - female patient.
Free written and oral consent.
Exclusion criteria:
Child under 2 years of age.
Body weight less than 17 kg.
Taking treatments that interfere with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD..
History of bone marrow transplantation.
History of diabetes after hemolytic-uremic syndrome.
Participation in another study within the last 3 months, with administration of blood derivatives or potentially immunomodulatory treatments. WP6 :
Inclusion Criteria:
Type 1 diabetic patient, as per ISPAD criteria;
Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.
Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose...
Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
Patients aged between 2 and 18 years (\<18 years).
Male - female patients
Free, written and oral consent.
Exclusion criteria:
Child under 2 years of age.
Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD.
Hepatic, renal or adrenal insufficiency.
History of bone marrow transplantation.
History of diabetes after hemolytic-uremic syndrome.
Epileptic patient
Dysmorphia with suspicion of underlying genetic syndrome.
Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments. WP7 :
Inclusion Criteria:
De novo type 1 diabetic patient, as per ISPAD criteria;
Symptoms of hyperglycemia: polyuria-polydipsia-amaigrin +/- Acido ketosis.
Fasting blood glucose ≥126 mg/dL AND/OR blood glucose ≥200 mg/dL at 120 minutes of an OGTT AND/OR HbA1c ≥6.5% AND/OR a patient with symptoms of hyperglycemia/hyperglycemic crisis (see 8. a. 2.) with random blood glucose...
Presence in serum of one or more anti-islet autoantibodies (anti-insulin, anti-IA2, anti-GAD65, anti-ZnT8)
Patients aged between 2 and 18 years
Minimum weight: 17 kg (for blood samples)
Male - female patients
Free, written and oral consent.
Exclusion criteria:
Child under 2 years of age.
Taking treatments interfering with insulin secretion and sensitivity (e.g. sulfonylureas, diazoxide, somatostatin, methylxanthine derivatives, corticosteroids, biguanide, incretins).
Presence of newly diagnosed (within 1 month) celiac disease (diagnosed on pathological duodenal biopsy) at inclusion.
Autoimmune/autoinflammatory disease (other than type 1 diabetes) or active malignancy present at inclusion.
Obesity defined as a BMI with a z-score \>+3 SD.
Hepatic, renal or adrenal insufficiency.
History of bone marrow transplantation.
History of diabetes after hemolytic-uremic syndrome.
Epileptic patient
Absence of anti-islet autoantibodies.
Dysmorphia with suspicion of underlying genetic syndrome.
Participation in another study in the previous 3 months, with administration of blood derivatives or potentially immunomodulating treatments.

The study team makes the final eligibility decision.

Where it's taking place

Brussels, Woluwe-saint-lambert, Belgium

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 2 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Brussels, Woluwe-saint-lambert, Belgium. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

Obesity Type 2 diabetes Type 1 diabetes Prediabetes Weight loss Metabolic syndrome High cholesterol High triglycerides High blood pressure PCOS Hypothyroidism Thyroid disease Gout Fatty liver disease (NAFLD/NASH)Heart failure Coronary artery disease

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.