Diabetes MellitusCMC-DMNCT02722655
Cohort of Mexican Children With Diabetes Mellitus (CMC-DM)
An observational study of Diabetes Mellitus, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Diabetes Mellitus
- How many people
- 500 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2008to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children and adolescents (boys and girls) from 1 months to 17 years of age that had recently been diagnosed with diabetes mellitus.
Who may be able to join
- Patients with confirmed diagnosis of diabetes mellitus
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Regional de Alta Especialidad del Bajío
León, Guanajuato, 37660
María L Evia-Viscarra, +52 (477) 2672000 ext. 1504, mlola.evia@hraeb.gob.mx
Edel R Rodea-Montero
About this study
Official title: Characteristics and Evolution of Diabetes Mellitus in Mexican Children: Cohort Study
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.
- Conditions
- Diabetes Mellitus
- Keywords
- Pediatrics
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic retinopathy
A microvascular complication determined by ophthalmological evaluation
Measured: year 3
Peripheral diabetic neuropathy
A microvascular complication determined by neurological exam in either foot
Measured: year 5
Nerve damage
A microvascular complication determined by nerve conduction study in either foot
Measured: year 5
Microalbuminuria
A microvascular complication determined by urine albumin excretion >= 30 mg/day
Measured: annual
Cardiac function
A cardiovascular risk indicator determined by echocardiogram
Measured: year 5
Cognitive evaluation
Determined by scores on the Mini-Mental State Examination
Measured: year 3
Intelligence quotient evaluation
Determined by Intelligence quotient test
Measured: year 3
Secondary outcomes (9)
Body composition
Determined by body mass index (BMI) percentiles computed from physical measurements of height and weight and corresponding percentile tables
Measured: annual
Glycemic control
Determined by HbA1c
Measured: annual
Beta cell function
Determined by fasting C peptide
Measured: annual
Pancreatic autoimmunity
Determined by pancreas autoantibodies
Measured: onset of diabetes
Insulin resistance
Determined by insulin sensitivity
Measured: annual
Alpha cell function
Determined by glucagon
Measured: year 5
Hyperlipidemia
Determined by lipid profile
Measured: annual
Hypothyroidism
Determined by thyroid profile
Measured: annual
Hypertension
Determined by collection of systolic and diastolic blood pressure and calculation of their percentile values
Measured: annual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startMar 2008
- Primary completionDec 2020 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Regional de Alta Especialidad del Bajio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Lola Evia-Viscarra, Hospital Regional de Alta Especialidad del Bajio
- Investigators
- María L Evia-Viscarra, Principal investigator, Department of Pediatric Endocrinology, Hospital Regional de Alta Especialidad del Bajío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722655
- Sponsor's protocol ID
- 2015-018
- Acronym
- CMC-DM
- Status last verified
- Aug 2017
- First submitted
- 18 Mar 2016
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Evolution of Diabetes Mellitus in Mexican Children: Cohort Study
- ClinicalTrials.gov ID
- NCT02722655
- Acronym / sponsor ID
- CMC-DM / 2015-018
- Conditions
- Diabetes Mellitus
- Keywords
- Pediatrics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Regional de Alta Especialidad del BajioUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 30 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children and adolescents (boys and girls) from 1 months to 17 years of age that had recently been diagnosed with diabetes mellitus.
Key inclusion criteria (1 listed)
- Patients with confirmed diagnosis of diabetes mellitus
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetic retinopathy
Time frame: year 3
A microvascular complication determined by ophthalmological evaluation
Peripheral diabetic neuropathy
Time frame: year 5
A microvascular complication determined by neurological exam in either foot
Nerve damage
Time frame: year 5
A microvascular complication determined by nerve conduction study in either foot
Microalbuminuria
Time frame: annual
A microvascular complication determined by urine albumin excretion >= 30 mg/day
Cardiac function
Time frame: year 5
A cardiovascular risk indicator determined by echocardiogram
Cognitive evaluation
Time frame: year 3
Determined by scores on the Mini-Mental State Examination
Intelligence quotient evaluation
Time frame: year 3
Determined by Intelligence quotient test
9 secondary outcomes
Body composition
Time frame: annual
Glycemic control
Time frame: annual
Beta cell function
Time frame: annual
Pancreatic autoimmunity
Time frame: onset of diabetes
Insulin resistance
Time frame: annual
Alpha cell function
Time frame: year 5
Hyperlipidemia
Time frame: annual
Hypothyroidism
Time frame: annual
Hypertension
Time frame: annual
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Derived from this study: PubMed 27992493Evia-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
María L Evia-Viscarra principal investigator
Department of Pediatric Endocrinology, Hospital Regional de Alta Especialidad del Bajío
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by Hospital Regional de Alta Especialidad del Bajio at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María L Evia-Viscarra (+52 (477) 2672000 ext. 1405, mlola.evia@hraeb.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic retinopathy (time frame: year 3). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02722655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2017.