Clinical trial NCT03312478: Association of Type 1 Diabetes Mellitus in Offsprings With Positive Parental History of Diabetes
Official title: To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2017-10-17
Enrollment: 375
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Odds of Type 1 Diabetes Mellitus child having a diabetic parent
timeFrame: 12 months
Secondary outcomes:
measure: Characterization of this population by gender
timeFrame: 12 months
measure: Characterization of this population by age
timeFrame: 12 months
measure: Characterization of this population by socio-economic profile
timeFrame: 12 months
measure: Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients
timeFrame: 12 months
measure: Standard deviation of HbA1c in T1DM patients
timeFrame: 12 months
measure: Distribution of prescribed therapies by type of insulin to T1DM patients
timeFrame: 12 months
measure: Means of fasting blood glucose (FBG) in T1DM patients
timeFrame: 12 months
measure: Standard deviation of FBG in T1DM patients
timeFrame: 12 months
measure: Duration of diabetes in parent
timeFrame: 12 months
measure: Mean duration of diabetes in parent
timeFrame: 12 months
measure: Characterization of family history of diabetes
timeFrame: 12 months
measure: Characterization of frequency of consultation
timeFrame: 12 months
measure: Characterization of diabetes education
timeFrame: 12 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: National Institute of Child Health
state: Sind
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: