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

Type 1 Diabetes Clinical Trial

— SHINE  

Official title:

To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03312478
• Other study ID #: LANTUL08473
• Secondary ID: U1111-1200-1995
• Status: Completed
• Phase: Phase 4
• Start date: October 13, 2017
• Est. completion date: August 19, 2018

Study information

• Verified date: April 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: August 19, 2018
• Est. primary completion date: August 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Blood draw for insulin auto-anti body tests*
Pharmaceutical form: N/A Route of administration: N/A

Locations

Country	Name	City	State
Pakistan	National Institute of Child Health	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odds of Type 1 Diabetes Mellitus child having a diabetic parent	Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables	12 months
Secondary	Characterization of this population by gender	Categorical variables (gender) will be presented as proportions	12 months
Secondary	Characterization of this population by age	Categorical variables (age) will be presented as proportions	12 months
Secondary	Characterization of this population by socio-economic profile	Categorical variables (socio-economic profile) will be presented as proportions	12 months
Secondary	Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients	Mean HbA1c	12 months
Secondary	Standard deviation of HbA1c in T1DM patients	Standard deviation of HbA1c	12 months
Secondary	Distribution of prescribed therapies by type of insulin to T1DM patients	Distribution of prescribed therapies by type of insulin will be presented as proportions	12 months
Secondary	Means of fasting blood glucose (FBG) in T1DM patients	Mean Fasting Blood Glucose	12 months
Secondary	Standard deviation of FBG in T1DM patients	Standard deviation of FBG	12 months
Secondary	Duration of diabetes in parent	Mean duration of diabetes in parent	12 months
Secondary	Mean duration of diabetes in parent	Standard deviation of duration of diabetes in parent	12 months
Secondary	Characterization of family history of diabetes	Categorical variables will be measured as proportions	12 months
Secondary	Characterization of frequency of consultation	Number of consultations per month	12 months
Secondary	Characterization of diabetes education	Number of sessions per month	12 months