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Trial record 82 of 1194 for:    Adenosine

Gene Study for Infantile Onset Diabetes

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ClinicalTrials.gov Identifier: NCT03169413
Recruitment Status : Not yet recruiting
First Posted : May 30, 2017
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
Shimaa Kamal, Assiut University

Brief Summary:

Diabetes mellitus is a group of metabolic diseases characterized by chronic hyperglycemia resulting from defects in insulin secretion, insulin action, or both.

According to American Diabetes Association diabetes can be classified into the following general categories: Type one diabetes (due to beta cell destruction, usually leading to absolute insulin deficiency), Type two diabetes (due to a progressive insulin secretory defect on the background of insulin resistance), Gestational diabetes mellitus and specific types of diabetes due to other causes, example monogenic diabetes syndromes (such as neonatal diabetes and maturity-onset diabetes of the young, diseases of the exocrine pancreas, and drug induced diabetes.


Condition or disease Intervention/treatment
Study Genetic Basis of Infantile Onset Diabetes Mellitus Genetic: Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive K channel gene in diabetic patients diagnosed under the age of one year.

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Human Leucocytic Antigen Typing and Mutation of Adenosine Triphosphate Sensitive Potassium Channel Gene in Diabetic Patients Diagnosed Under the Age of One Year.
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
cases
Fifty diabetic children diagnosed under the age of one year subjected to genetic analysis to study human leucocytic antigen haplotype class two (DR-DQ) and detection of mutations in the potassium channel, inwardly rectifying subfamily J member 11 gene encoding the Kir6.2 subunit of adenosine triphosphate sensitive potassium channel also possible risk factors associated with the disease.
Genetic: Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive K channel gene in diabetic patients diagnosed under the age of one year.
Gene study

control one
Twenty five diabetic children diagnosed after the age of one year subjected to genetic study to study human leucocytic antigen and possible of presence of gene mutation of the potassium channel, inwardly rectifying subfamily J member 11 gene encoding the Kir6.2 subunit of adenosine triphosphate sensitive potassium channel and possible risk factors associated with disease .
Genetic: Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive K channel gene in diabetic patients diagnosed under the age of one year.
Gene study

control two
Twenty five healthy children matched by age subjected to genetic study to study human leucocytic antigen and possible of presence of gene mutation of the potassium channel, inwardly rectifying subfamily J member 11 gene encoding the Kir6.2 subunit of adenosine triphosphate sensitive potassium channel and exposure to similar risk factors associated with disease .
Genetic: Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive K channel gene in diabetic patients diagnosed under the age of one year.
Gene study




Primary Outcome Measures :
  1. Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive potassium channel gene in diabetic patients diagnosed under the age of one year. [ Time Frame: At time of diagnosis with diabetes under the age of one year ]
    Polymerase chain reaction / Deoxyribonucleic acid sequencing


Secondary Outcome Measures :
  1. Rate of diabetes mellitus in patients under age of one year attending pediatric endocrinology unit in Pediatric assiut University Hospital [ Time Frame: Within two years ]
    Total coverage of all diabetic cases diagnosed under the age of one year

  2. dentification of possible demographic and environmental risk factors associated with increased risk of diabetes in diabetic patient under the age of one year. [ Time Frame: Within two years ]
    Identification of prenatal, perinatal, natal history,nutritional history, vaccination history and hygiene measures



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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patient diagnosed under the age of one year within two years, 50 randomly chosen patients will subjected to genetic analysis and two control group one will include 25 diabetic patient diagnosed after the age of one year matched by gender and by age (within a few days of birth), the other group include 25 healthy children from the community matched by gender and by age (within a few days of birth).
Criteria

Inclusion Criteria:

  • Diabetic patients with disease onset under the age of one year according to American Diabetes Association criteria 2016 which include:
  • Fasting plasma glucose level at or above 7 millimol/Litre.
  • Plasma glucose at or above 11.1 millimol/Litre two hours after a 1.75 gram/kilogram oral glucose load as in a glucose tolerance test.
  • Symptoms of hyperglycemia and random plasma glucose at or above 11.1 millimol/Litre.
  • Glycated hemoglobin at or above 48 millimol/mol.

Exclusion Criteria:

-Diabetic children with the disease onset above the age of one year.


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): NCT03169413


Contacts
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Contact: Prof Hanaa Abdellatif Mohamed, MD 01120096055 Hae50@hotmail.com
Contact: Kotb Abbas Metwally, MD 01003912599 Kotb72@yahoo.com

Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Shimaa Kamal, Principle Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03169413     History of Changes
Other Study ID Numbers: IDM
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenosine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Vasodilator Agents
Purinergic P1 Receptor Agonists
Purinergic Agonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action