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

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT02722655
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-17
• Last Update Posted: 2017-08-22
• Primary Completion: 2020-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with confirmed diagnosis of diabetes mellitus

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Exclusion Criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Peripheral diabetic neuropathy	year 5	A microvascular complication determined by neurological exam in either foot
Microalbuminuria	annual	A microvascular complication determined by urine albumin excretion \>= 30 mg/day
Cognitive evaluation	year 3	Determined by scores on the Mini-Mental State Examination
Diabetic retinopathy	year 3	A microvascular complication determined by ophthalmological evaluation
Nerve damage	year 5	A microvascular complication determined by nerve conduction study in either foot
Cardiac function	year 5	A cardiovascular risk indicator determined by echocardiogram
Intelligence quotient evaluation	year 3	Determined by Intelligence quotient test

Secondary Outcome Measures

Name	Time	Method
Hypothyroidism	annual	Determined by thyroid profile
Glycemic control	annual	Determined by HbA1c
Pancreatic autoimmunity	onset of diabetes	Determined by pancreas autoantibodies
Alpha cell function	year 5	Determined by glucagon
Hyperlipidemia	annual	Determined by lipid profile
Body composition	annual	Determined by body mass index (BMI) percentiles computed from physical measurements of height and weight and corresponding percentile tables
Beta cell function	annual	Determined by fasting C peptide
Insulin resistance	annual	Determined by insulin sensitivity
Hypertension	annual	Determined by collection of systolic and diastolic blood pressure and calculation of their percentile values

Trial Locations

Locations (1)

Hospital Regional de Alta Especialidad del Bajío; 🇲🇽 Leon, Guanajuato, Mexico