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

NCT ID: NCT03312478

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-13
• Study Completion Date: 2018-08-19

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 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.

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 patients shall be conducted after 15 days ± 5 days.

*Each patient (cases as well as controls) will be required to undergo laboratory tests for insulin autoantibodies and hemoglobin A1c tests. Both the tests will be conducted through centralized laboratories for all recruited patients.

Since the result of insulin auto-antibodies test is one of the inclusion criteria, it is mandatory for all patients to undergo this test, and detailed information for the same has been included in the informed consent form.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Case

Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases

Group Type: OTHER

Blood draw for insulin auto-anti body tests*

Intervention Type: DRUG

Pharmaceutical form: N/A

Route of administration: N/A

Control

Age-matched non-diabetic controls as described in the inclusion criteria for controls

Group Type: OTHER

Blood draw for insulin auto-anti body tests*

Intervention Type: DRUG

Pharmaceutical form: N/A

Route of administration: N/A

Interventions

Blood draw for insulin auto-anti body tests*

Pharmaceutical form: N/A

Route of administration: N/A

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Age ≤ 2 years and >20 years.
• Patients with any other pre-existing auto-immune disease.
• Gestational Diabetes.
• Pregnant Woman.

• 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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

National Institute of Child Health

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

U1111-1200-1995

Identifier Type: OTHER

Identifier Source: secondary_id

LANTUL08473

Identifier Type: -

Identifier Source: org_study_id