CClinicalTrials.gg
RecruitingNCT02722655CMC-DMUpdated Aug 22, 2017

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

An observational study in Diabetes Mellitus, sponsored by Hospital Regional de Alta Especialidad del Bajio. Recruiting at 1 site in Mexico. Open to participants aged 1 Month to 17 Years. Per ClinicalTrials.gov, last updated 2017-08-22.

Sponsored by Hospital Regional de Alta Especialidad del Bajio · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2020, 5 years 10 months ago, but the record still lists the study as recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
1 Month to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

Browse trials for

Keywords

  • Pediatrics
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 500 is above the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Hospital Regional de Alta Especialidad del Bajio is the lead sponsor of 12 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • Patients with confirmed diagnosis of diabetes mellitus

Exclusion criteria

Exclusion Criteria:

-

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Type 1 diabetes mellitus

    Sudden onset of symptoms and non-overweight/obese

  • Type 2 diabetes mellitus

    Insidious onset of symptoms and overweight/obese

  • Type 1.5 diabetes mellitus

    Overlap of type 1 and type2 diabetes mellitus clinical characteristics

  • Other types of diabetes mellitus

    According American Diabetes Association criteria

06

What researchers measure

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

  5. Cardiac function

    A cardiovascular risk indicator determined by echocardiogram

    Time frame: year 5

  6. Cognitive evaluation

    Determined by scores on the Mini-Mental State Examination

    Time frame: year 3

  7. Intelligence quotient evaluation

    Determined by Intelligence quotient test

    Time frame: year 3

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

  5. Insulin resistance

    Determined by insulin sensitivity

    Time frame: annual

  6. Alpha cell function

    Determined by glucagon

    Time frame: year 5

  7. Hyperlipidemia

    Determined by lipid profile

    Time frame: annual

  8. Hypothyroidism

    Determined by thyroid profile

    Time frame: annual

  9. Hypertension

    Determined by collection of systolic and diastolic blood pressure and calculation of their percentile values

    Time frame: annual

07

Study locations

1 of 1 sites recruiting
  • Hospital Regional de Alta Especialidad del Bajío
    Leon, Guanajuato 37660, Mexico
    • María L Evia-Viscarra · Contact · mlola.evia@hraeb.gob.mx · +52 (477) 2672000
    • Edel R Rodea-Montero · Sub investigator
    • Rodolfo Guardado-Mendoza · Sub investigator
    Recruiting
08

References and documents

Publications

  • Evia-Viscarra ML, Guardado-Mendoza R, Rodea-Montero ER. Clinical and Metabolic Characteristics among Mexican Children with Different Types of Diabetes Mellitus. PLoS One. 2016 Dec 16;11(12):e0168377. doi: 10.1371/journal.pone.0168377. eCollection 2016. PubMed 27992493 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02722655
Lead sponsor
Hospital Regional de Alta Especialidad del Bajio
Responsible party
Maria Lola Evia-Viscarra (Pediatric Endocrinologist, Hospital Regional de Alta Especialidad del Bajio) — Principal investigator
First posted
Mar 30, 2016
Start date
Mar 2008
Primary completion
Dec 2020 (estimated)
Completion
Dec 2030 (estimated)
Last update
Aug 22, 2017

Study contacts

María L Evia-Viscarra
Contact
mlola.evia@hraeb.gob.mx
+52 (477) 2672000 ext. 1405
María L Evia-Viscarra
principal investigator · Department of Pediatric Endocrinology, Hospital Regional de Alta Especialidad del Bajío

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion