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

NCT03312478 | Completed Phase 4

• 2 other identifiers: LANTUL08473U1111-1200-1995
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Characterization of this population by gender

  12 months

• Characterization of this population by age

  12 months

• Characterization of this population by socio-economic profile

  12 months

• Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients

  12 months

• Standard deviation of HbA1c in T1DM patients

  12 months

Study Arms (2)

Case

OTHER

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

Drug: Blood draw for insulin auto-anti body tests*

Control

OTHER

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

Drug: Blood draw for insulin auto-anti body tests*

Interventions

Blood draw for insulin auto-anti body tests* DRUG

Pharmaceutical form: N/A Route of administration: N/A

Case; Control

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

National Institute of Child Health

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: October 17, 2017
• Study Start: October 13, 2017
• Primary Completion: August 19, 2018
• Study Completion: August 19, 2018
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

PA (1)