ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03312478
Recruitment Status : Active, not recruiting
First Posted : October 17, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Blood draw for insulin auto-anti body tests* Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Evaluate the Association Between Type 1 Diabetes Mellitus (T1DM) in Offspring With Positive Parental History of Diabetes
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Case
Known cases of type 1 diabetes mellitus as described in the inclusion criteria for cases
Drug: Blood draw for insulin auto-anti body tests*

Pharmaceutical form: N/A

Route of administration: N/A


Control
Age-matched non-diabetic controls as described in the inclusion criteria for controls
Drug: Blood draw for insulin auto-anti body tests*

Pharmaceutical form: N/A

Route of administration: N/A





Primary Outcome Measures :
  1. Odds of Type 1 Diabetes Mellitus child having a diabetic parent [ Time Frame: 12 months ]
    Odds ratio will be used to calculate and measure disease frequency from dichotomous categorical variables


Secondary Outcome Measures :
  1. Characterization of this population by gender [ Time Frame: 12 months ]
    Categorical variables (gender) will be presented as proportions

  2. Characterization of this population by age [ Time Frame: 12 months ]
    Categorical variables (age) will be presented as proportions

  3. Characterization of this population by socio-economic profile [ Time Frame: 12 months ]
    Categorical variables (socio-economic profile) will be presented as proportions

  4. Means of HbA1c in Type 1 diabetes mellitus (T1DM) patients [ Time Frame: 12 months ]
    Mean HbA1c

  5. Standard deviation of HbA1c in T1DM patients [ Time Frame: 12 months ]
    Standard deviation of HbA1c

  6. Distribution of prescribed therapies by type of insulin to T1DM patients [ Time Frame: 12 months ]
    Distribution of prescribed therapies by type of insulin will be presented as proportions

  7. Means of fasting blood glucose (FBG) in T1DM patients [ Time Frame: 12 months ]
    Mean Fasting Blood Glucose

  8. Standard deviation of FBG in T1DM patients [ Time Frame: 12 months ]
    Standard deviation of FBG

  9. Duration of diabetes in parent [ Time Frame: 12 months ]
    Mean duration of diabetes in parent

  10. Mean duration of diabetes in parent [ Time Frame: 12 months ]
    Standard deviation of duration of diabetes in parent

  11. Characterization of family history of diabetes [ Time Frame: 12 months ]
    Categorical variables will be measured as proportions

  12. Characterization of frequency of consultation [ Time Frame: 12 months ]
    Number of consultations per month

  13. Characterization of diabetes education [ Time Frame: 12 months ]
    Number of sessions per month



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312478


Locations
Pakistan
National Institute of Child Health
Karachi, Sind, Pakistan, 75510
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03312478     History of Changes
Other Study ID Numbers: LANTUL08473
U1111-1200-1995 ( Other Identifier: UTN )
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://www.clinicalstudydatarequest.com/
URL: http://

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs