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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-17
SponsorHospital Regional de Alta Especialidad del Bajio

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with confirmed diagnosis of diabetes mellitus

Disqualifiers

None

Trial population

Children and adolescents (boys and girls) from 1 months to 17 years of age that had recently been diagnosed with diabetes mellitus.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

500 Participants
are grouped into 4 trial groups
Group A: Type 1 diabetes mellitus
Group B: Type 2 diabetes mellitus
Group C: Type 1.5 diabetes mellitus
Group D: Other types of diabetes mellitus

Trial outcomes

Primary outcomes

1

Diabetic retinopathy

A microvascular complication determined by ophthalmological evaluation

Time frame
year 3
2

Peripheral diabetic neuropathy

A microvascular complication determined by neurological exam in either foot

Time frame
year 5
3

Nerve damage

A microvascular complication determined by nerve conduction study in either foot

Time frame
year 5
4

Microalbuminuria

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

Time frame
annual

Secondary outcomes

1

Body composition

Determined by body mass index (BMI) percentiles computed from physical measurements of height and weight and corresponding percentile tables

Time frame
annual
2

Glycemic control

Determined by HbA1c

Time frame
annual
3

Beta cell function

Determined by fasting C peptide

Time frame
annual
4

Pancreatic autoimmunity

Determined by pancreas autoantibodies

Time frame
onset of diabetes

Other outcomes

Sponsors and contacts

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