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

Diabetes Mellitus Clinical Trial

— CMC-DM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02722655
• Other study ID #: 2015-018
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2016
• Last updated: August 17, 2017
• Start date: March 2008
• Est. completion date: December 2030

Study information

• Verified date: August 2017
• Source: Hospital Regional de Alta Especialidad del Bajio
• Contact: María L Evia-Viscarra
• Phone: +52 (477) 2672000
• Email: mlola.evia[@]hraeb.gob.mx
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2030
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

Inclusion Criteria:

• Patients with confirmed diagnosis of diabetes mellitus

Exclusion Criteria:

Related Conditions & MeSH terms

• Diabetes Mellitus

Locations

Country	Name	City	State
Mexico	Hospital Regional de Alta Especialidad del Bajío	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Regional de Alta Especialidad del Bajio

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetic retinopathy	A microvascular complication determined by ophthalmological evaluation	year 3
Primary	Peripheral diabetic neuropathy	A microvascular complication determined by neurological exam in either foot	year 5
Primary	Nerve damage	A microvascular complication determined by nerve conduction study in either foot	year 5
Primary	Microalbuminuria	A microvascular complication determined by urine albumin excretion >= 30 mg/day	annual
Primary	Cardiac function	A cardiovascular risk indicator determined by echocardiogram	year 5
Primary	Cognitive evaluation	Determined by scores on the Mini-Mental State Examination	year 3
Primary	Intelligence quotient evaluation	Determined by Intelligence quotient test	year 3
Secondary	Body composition	Determined by body mass index (BMI) percentiles computed from physical measurements of height and weight and corresponding percentile tables	annual
Secondary	Glycemic control	Determined by HbA1c	annual
Secondary	Beta cell function	Determined by fasting C peptide	annual
Secondary	Pancreatic autoimmunity	Determined by pancreas autoantibodies	onset of diabetes
Secondary	Insulin resistance	Determined by insulin sensitivity	annual
Secondary	Alpha cell function	Determined by glucagon	year 5
Secondary	Hyperlipidemia	Determined by lipid profile	annual
Secondary	Hypothyroidism	Determined by thyroid profile	annual
Secondary	Hypertension	Determined by collection of systolic and diastolic blood pressure and calculation of their percentile values	annual