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Cohort of Mexican Children With Diabetes Mellitus (CMC-DM) (CMC-DM)

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ClinicalTrials.gov Identifier: NCT02722655
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio

Brief Summary:
The aim of this study is the identification of complications in diabetes mellitus pediatric patients and to compare the clinical, anthropometric, and biochemical characteristics between children in the different types of diabetes mellitus.

Condition or disease
Diabetes Mellitus

Detailed Description:
Diabetes mellitus is characterized by hyperglycemia resulting from defects in insulin secretion and/or insulin resistance in target tissues. This study identify the influence of pathogenic factors on the evolution of diabetes mellitus and in the presence of chronic complications.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics and Evolution of Diabetes Mellitus in Mexican Children: Cohort Study
Study Start Date : March 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2030

Group/Cohort
Type 1 diabetes mellitus
Sudden onset of symptoms and non-overweight/obese
Type 2 diabetes mellitus
Insidious onset of symptoms and overweight/obese
Type 1.5 diabetes mellitus
Overlap of type 1 and type2 diabetes mellitus clinical characteristics
Other types of diabetes mellitus
According American Diabetes Association criteria



Primary Outcome Measures :
  1. Diabetic retinopathy [ Time Frame: year 3 ]
    A microvascular complication determined by ophthalmological evaluation

  2. Peripheral diabetic neuropathy [ Time Frame: year 5 ]
    A microvascular complication determined by neurological exam in either foot

  3. Nerve damage [ Time Frame: year 5 ]
    A microvascular complication determined by nerve conduction study in either foot

  4. Microalbuminuria [ Time Frame: annual ]
    A microvascular complication determined by urine albumin excretion >= 30 mg/day

  5. Cardiac function [ Time Frame: year 5 ]
    A cardiovascular risk indicator determined by echocardiogram

  6. Cognitive evaluation [ Time Frame: year 3 ]
    Determined by scores on the Mini-Mental State Examination

  7. Intelligence quotient evaluation [ Time Frame: year 3 ]
    Determined by Intelligence quotient test


Secondary Outcome Measures :
  1. Body composition [ Time Frame: annual ]
    Determined by body mass index (BMI) percentiles computed from physical measurements of height and weight and corresponding percentile tables

  2. Glycemic control [ Time Frame: annual ]
    Determined by HbA1c

  3. Beta cell function [ Time Frame: annual ]
    Determined by fasting C peptide

  4. Pancreatic autoimmunity [ Time Frame: onset of diabetes ]
    Determined by pancreas autoantibodies

  5. Insulin resistance [ Time Frame: annual ]
    Determined by insulin sensitivity

  6. Alpha cell function [ Time Frame: year 5 ]
    Determined by glucagon

  7. Hyperlipidemia [ Time Frame: annual ]
    Determined by lipid profile

  8. Hypothyroidism [ Time Frame: annual ]
    Determined by thyroid profile

  9. Hypertension [ Time Frame: annual ]
    Determined by collection of systolic and diastolic blood pressure and calculation of their percentile values



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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children and adolescents (boys and girls) from 1 months to 17 years of age that had recently been diagnosed with diabetes mellitus.
Criteria

Inclusion Criteria:

  • Patients with confirmed diagnosis of diabetes mellitus

Exclusion Criteria:

-


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): NCT02722655


Contacts
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Contact: María L Evia-Viscarra +52 (477) 2672000 ext 1405 mlola.evia@hraeb.gob.mx

Locations
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Mexico
Hospital Regional de Alta Especialidad del Bajío Recruiting
Leon, Guanajuato, Mexico, 37660
Contact: María L Evia-Viscarra    +52 (477) 2672000 ext 1504    mlola.evia@hraeb.gob.mx   
Sub-Investigator: Edel R Rodea-Montero         
Sub-Investigator: Rodolfo Guardado-Mendoza         
Sponsors and Collaborators
Hospital Regional de Alta Especialidad del Bajio
Investigators
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Principal Investigator: María L Evia-Viscarra Department of Pediatric Endocrinology, Hospital Regional de Alta Especialidad del Bajío

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Lola Evia-Viscarra, Pediatric Endocrinologist, Hospital Regional de Alta Especialidad del Bajio
ClinicalTrials.gov Identifier: NCT02722655     History of Changes
Other Study ID Numbers: 2015-018
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio:
Pediatrics

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases