Status:
COMPLETED
Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
Lead Sponsor:
Sanofi
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-20 years
Phase:
PHASE4
Brief 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 d...
Detailed Description
The overall duration of this study is expected to be 12 months. The recruitment period for a given center will be four months following site initiation of that center. telephonic follow-up for all the...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2018
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT03312478
Start Date
October 13 2017
End Date
August 19 2018
Last Update
April 25 2022
Active Locations (1)
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1
National Institute of Child Health
Karachi, Sindh, Pakistan, 75510