Diabetes Mellitus, Type 2NCT03767608
Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus
An observational study of Diabetes Mellitus, Type 2 and Pediatric Obesity, run by Instituto Tecnologico y de Estudios Superiores de Monterey at 1 site in Mexico.
Trial summary
The objective of this study was to investigate the association of irisin with inflammatory markers as well with metabolic and anthropometric parameters in children and adolescents with type 2 diabetes mellitus compared with healthy controls. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pediatric Obesity
- How many people
- 40 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- Child
Study population: 40 Mexican children and adolescents aged 7-17 (20 boys and 20 girls) 20 children and adolescents diagnosed with T2DM and 20 healthy controls
Who may be able to join
- Have been previously diagnosed with T2DM according to the American Diabetes Association (ADA) criteria .
- Healthy controls were required to have:
- Normal weight according to the Centers for Disease Control and Prevention (CDC) criteria.
- No metabolic abnormalities on blood samples
- No previously diagnosed cardiometabolic diseases
- Not been using antihypertensive, lipid or glucose lowering medications
Who cannot join
- Disapproval by the children's physician due to any at-risk medical condition known by the parents
- Use of drugs for high blood pressure, hyperglycemia, or dyslipidemia
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Clinical Nutrition and Obesity Research Center. School of Medicine, TEC Salud, Tecnológico de Monterrey
Monterrey, Nuevo León, 64710
About this study
The objective of this study was to investigate the association of irisin with inflammatory markers as well with metabolic and anthropometric parameters in children and adolescents with type 2 diabetes mellitus compared with healthy controls.
Read the detailed description
Mexican children and adolescents previously diagnosed with type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria were recruited and compared to healthy controls.
The participants will undergo:
- vital signs measurement (systolic and diastolic blood pressure, heart rate, respiratory rate)
- anthropometric variables measurement (BMI, weight, waist circumference, hip circumference, body fat %)
- laboratory studies: glucose, triglycerides, HDL-c, C reactive protein, irisin
After statistical analyses the investigators will compare the relationship of irisin and the inflammatory profile and the anthropometric parameters of diabetic patients versus lean controls.
- Conditions
- Diabetes Mellitus, Type 2, Pediatric Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Pediatric Obesity
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 |
|---|---|---|
| Patients with type 2 diabetes mellitus | Patients diagnosed with T2DM according to the ADA | |
| Lean healthy controls | Lean healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM)
Correlation of irisin levels and anthropometric parameters in children with T2DM
Measured: 1 day
Correlation of irisin levels and anthropometric parameters in healthy control children
Correlation of irisin levels and anthropometric parameters in healthy control children
Measured: 1 day
Correlation of irisin levels and cytokines levels in children with T2DM
Correlation of irisin levels and cytokines levels in children with T2DM
Measured: 1 day
Correlation of irisin levels and C reactive protein levels in healthy control children
Correlation of irisin levels and C reactive protein levels in healthy control children
Measured: 1 day
Comparison between groups
Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study startJan 2016
- Primary completion1 Jan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de Monterey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leticia Elizondo-Montemayor, Instituto Tecnologico y de Estudios Superiores de Monterey
- Investigators
- Leticia Elizondo-Montemayor, MD, Principal investigator, Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767608
- Sponsor's protocol ID
- AIEMPPDM2SM
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Irisin, Inflammatory Markers and Metabolic Status in Obese Children With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03767608
- Acronym / sponsor ID
- AIEMPPDM2SM
- Conditions
- Diabetes Mellitus, Type 2, Pediatric Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Instituto Tecnologico y de Estudios Superiores de MontereyUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 6 Dec 2018 (actual)
- 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 objective of this study was to investigate the association of irisin with inflammatory markers as well with metabolic and anthropometric parameters in children and adolescents with type 2 diabetes mellitus compared with healthy controls.
Detailed description
Mexican children and adolescents previously diagnosed with type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria were recruited and compared to healthy controls.
The participants will undergo:
- vital signs measurement (systolic and diastolic blood pressure, heart rate, respiratory rate)
- anthropometric variables measurement (BMI, weight, waist circumference, hip circumference, body fat %)
- laboratory studies: glucose, triglycerides, HDL-c, C reactive protein, irisin
After statistical analyses the investigators will compare the relationship of irisin and the inflammatory profile and the anthropometric parameters of diabetic patients versus lean controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with type 2 diabetes mellitus | – | –Patients diagnosed with T2DM according to the ADA |
| Lean healthy controls | – | –Lean healthy controls |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Age groups
- Child
- Study population
- 40 Mexican children and adolescents aged 7-17 (20 boys and 20 girls) 20 children and adolescents diagnosed with T2DM and 20 healthy controls
Key inclusion criteria (6 listed)
- Have been previously diagnosed with T2DM according to the American Diabetes Association (ADA) criteria .
- Normal weight according to the Centers for Disease Control and Prevention (CDC) criteria.
- No metabolic abnormalities on blood samples
- No previously diagnosed cardiometabolic diseases
- Not been using antihypertensive, lipid or glucose lowering medications
Key exclusion criteria (2 listed)
- Disapproval by the children's physician due to any at-risk medical condition known by the parents
- Use of drugs for high blood pressure, hyperglycemia, or dyslipidemia
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
Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM)
Time frame: 1 day
Correlation of irisin levels and anthropometric parameters in children with T2DM
Correlation of irisin levels and anthropometric parameters in healthy control children
Time frame: 1 day
Correlation of irisin levels and anthropometric parameters in healthy control children
Correlation of irisin levels and cytokines levels in children with T2DM
Time frame: 1 day
Correlation of irisin levels and cytokines levels in children with T2DM
Correlation of irisin levels and C reactive protein levels in healthy control children
Time frame: 1 day
Correlation of irisin levels and C reactive protein levels in healthy control children
Comparison between groups
Time frame: 1 day
Compare the correlations of irisin woth anthropometric parameters and INFLAMMATORY MARKERSbetween children diagnosed with T2DM and healthy controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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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. This study is not recruiting at the moment.
Leticia Elizondo-Montemayor, MD principal investigator
Tecnologico de Monterrey, Escuela de Medicina y Ciencias de la Salud
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, Type 2 and Pediatric Obesity, run by Instituto Tecnologico y de Estudios Superiores de Monterey 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 6 Dec 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of irisin levels and anthropometric parameters in children with type 2 diabetes mellitus (T2DM) (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2018.