Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes

• Status: Completed
• Trial end date: 2018-08-19
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

To measure the association between a parental history of diabetes and the odds of an offspring being Type 1 diabetics.

Secondary Objectives:

• To document the profile of Type 1 diabetes patients.

• To document the glycemic parameters (Fasting blood glucose [FBG] and glycosylated hemoglobin [HbA1c]) of Type 1 diabetes.

• To capture the current therapeutic management.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sanofi
• Treatments: Antibodies

Criteria

Inclusion criteria :

Inclusion Criteria for Cases

• Age ≥ 2 years and ≤ 20 years.

• Type 1 diabetes mellitus (T1DM) at any stage of life assessed as:

• Insulin initiated within one year of diagnosis.

• One or more islet autoantibodies (insulin auto-antibodies [IAA], glutamic acid decarboxylase (GAD), or IA2) positive at the time of enrolment. The laboratory value for IAA ≥ 2.4 units/mL, ≥ 10 IU/mL for IA2 and ≥ 5 IU/mL for anti-GAD to be labelled as positive.

• Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than legal limit which is 18 years of age.

Inclusion Criteria for Controls

• Age ≥ 2 years and ≤ 20 years. Every control will be matched for a specific patient within ± two years of age.

• Non diabetic.

• All islet autoantibodies negative at the time of enrolment (IAA, GAD, or IA2). The laboratory value for IAA ≤ 2.4 units/mL, ≤ 10 IU/mL for IA2, and ≤ 5 IU/mL for anti-GAD to be labelled as negative.

• Consenting to participate in the study or care giver ready to sign data release consent if the patient is less than 18 years of age.

Exclusion criteria:

Exclusion Criteria for Cases:

• Age ≤ 2 years and >20 years.

• Patients with any other pre-existing auto-immune disease.

• Gestational Diabetes.

• Pregnant Woman.

Exclusion Criteria for Controls:

• Age ≤ 2 years and > 20 years.

• Patient with history of Type 1 (T1) and Type 2 Diabetes Mellitus (T2DM).

• History of T1 and T2DM in siblings.

• Gestational Diabetes.

• Pregnant Woman.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.