NCT02722655

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2008Dec 2030

Study Start

First participant enrolled

March 1, 2008

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Expected
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

12.8 years

First QC Date

March 18, 2016

Last Update Submit

August 17, 2017

Conditions

Keywords

Pediatrics

Outcome Measures

Primary Outcomes (7)

  • Diabetic retinopathy

    A microvascular complication determined by ophthalmological evaluation

    year 3

  • Peripheral diabetic neuropathy

    A microvascular complication determined by neurological exam in either foot

    year 5

  • Nerve damage

    A microvascular complication determined by nerve conduction study in either foot

    year 5

  • Microalbuminuria

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

    annual

  • Cardiac function

    A cardiovascular risk indicator determined by echocardiogram

    year 5

  • Cognitive evaluation

    Determined by scores on the Mini-Mental State Examination

    year 3

  • Intelligence quotient evaluation

    Determined by Intelligence quotient test

    year 3

Secondary Outcomes (9)

  • Body composition

    annual

  • Glycemic control

    annual

  • Beta cell function

    annual

  • Pancreatic autoimmunity

    onset of diabetes

  • Insulin resistance

    annual

  • +4 more secondary outcomes

Study Arms (4)

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

Eligibility Criteria

Age1 Month - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Patients with confirmed diagnosis of diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Regional de Alta Especialidad del Bajío

León, Guanajuato, 37660, Mexico

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • María L Evia-Viscarra

    Department of Pediatric Endocrinology, Hospital Regional de Alta Especialidad del Bajío

    PRINCIPAL INVESTIGATOR

Central Study Contacts

María L Evia-Viscarra

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Endocrinologist

Study Record Dates

First Submitted

March 18, 2016

First Posted

March 30, 2016

Study Start

March 1, 2008

Primary Completion

December 1, 2020

Study Completion (Estimated)

December 1, 2030

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations