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NCT Number: NCT02722655

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Regional de Alta Especialidad del Bajío

León, Guanajuato, 37660, Mexico

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with confirmed diagnosis of diabetes mellitus

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hospital Regional de Alta Especialidad del Bajio

Other

Registry information

Official study title

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

Acronym: CMC-DM

Important dates

Study start
2008
Primary completion
2020
Study completion
2030
First posted
Mar 30, 2016
Registry last updated
Aug 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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