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Clinical Trials/NCT02722655
NCT02722655
Recruiting
Not Applicable

Characteristics and Evolution of Diabetes Mellitus in Mexican Children: Cohort Study

Hospital Regional de Alta Especialidad del Bajio1 site in 1 country500 target enrollmentMarch 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Hospital Regional de Alta Especialidad del Bajio
Enrollment
500
Locations
1
Primary Endpoint
Peripheral diabetic neuropathy
Status
Recruiting
Last Updated
8 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2008
End Date
December 2030
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Maria Lola Evia-Viscarra

Pediatric Endocrinologist

Hospital Regional de Alta Especialidad del Bajio

Eligibility Criteria

Inclusion Criteria

  • Patients with confirmed diagnosis of diabetes mellitus

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Peripheral diabetic neuropathy

Time Frame: year 5

A microvascular complication determined by neurological exam in either foot

Microalbuminuria

Time Frame: annual

A microvascular complication determined by urine albumin excretion \>= 30 mg/day

Cognitive evaluation

Time Frame: year 3

Determined by scores on the Mini-Mental State Examination

Diabetic retinopathy

Time Frame: year 3

A microvascular complication determined by ophthalmological evaluation

Nerve damage

Time Frame: year 5

A microvascular complication determined by nerve conduction study in either foot

Cardiac function

Time Frame: year 5

A cardiovascular risk indicator determined by echocardiogram

Intelligence quotient evaluation

Time Frame: year 3

Determined by Intelligence quotient test

Secondary Outcomes

  • Glycemic control(annual)
  • Pancreatic autoimmunity(onset of diabetes)
  • Body composition(annual)
  • Beta cell function(annual)
  • Alpha cell function(year 5)
  • Hyperlipidemia(annual)
  • Hypothyroidism(annual)
  • Insulin resistance(annual)
  • Hypertension(annual)

Study Sites (1)

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