ObesityPhase 2NCT02063802
Metformin vs Conjugated Linoleic Acid and an Intervention Program With Healthy Habits in Obese Children
A Phase 2 study testing metformin, Conjugated Linoleic Acid and Healthy habits program in people with Obesity, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.
Trial summary
The purpose of this clinical trial is to examine the effects of conjugated linoleic acid (CLA) vs metformin along with an intervention program with healthy habits on body composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular and genetic changes in obese children. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- metformin, Conjugated Linoleic Acid and Healthy habits program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2012to May 2014
- Phase
- Phase 2
- 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients of both sexes between 8 and 18 years old
- Pc BMI ≥ 95 and <35kg/m2,
- No endocrine diseases, including diabetes mellitus
- No systemic diseases
- No genetic diseases
- No pharmacological treatment affecting lipid metabolism or glucose
Show all 9Show fewer
- No history of acute or prolonged immobilization
- Normal aminotransferases
- Signed Informed consent and assent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
General Hospital of Mexico
Mexico City, Mexico City, 06726
Nayely G Garibay, Pediatrician, +52 (55) 59-48-26-37, gngaribay@hotmail.com
Mayra A Bustos, Doctor, +52 7773406509, mayibe2609@gmail.com
About this study
Official title: Effect of an Intervention Program With Healthy Habits Plus Metformin or Conjugated Linoleic Acid Over Clinical Parameters and Molecular Pathways of Insulin Resistance in Obese Pediatric Patients
The purpose of this clinical trial is to examine the effects of conjugated linoleic acid (CLA) vs metformin along with an intervention program with healthy habits on body composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular and genetic changes in obese children.
Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metforminDrug
total dose: 1 gr per day (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.
Conjugated Linoleic AcidDietary supplement
total dose: 3gr/día(500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner for four months.
PlaceboDrug
Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months
Healthy habits programBehavioural
| Study group | Role | What they receive |
|---|---|---|
| metformin and healthy habits program | Active comparator | 1 gr per day. (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months. Receives: Drug: metformin; Behavioral: Healthy habits program |
| Conjugated Linoleic Acid and healthy habits | Experimental | Total dose: 3gr per day (500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner by mouth for four months. Receives: Dietary Supplement: Conjugated Linoleic Acid; Behavioral: Healthy habits program |
| Placebo and healthy habits program | Placebo comparator | Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months. Receives: Drug: Placebo; Behavioral: Healthy habits program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body mass index at 4 months
Measured: baseline, 4 months
Change in body fat mass at 4 months
Measured: baseline, 4 months
Change in lean body mass at 4 months
Measured: baseline, 4 months
Secondary outcomes (9)
Change in clinical laboratory values at 4 months
Measured: baseline, 4 months
Change in M Value in CLAMP at 4 months
Measured: baseline, 4 months
Change in muscle tissue transcriptome at 4 months
Measured: baseline, 4 months
Change in adipose tissue transcriptome at 4 months
Measured: baseline, 4 months
Change in inflammatory cytokines al 4 months
Measured: baseline, 4 months
Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months
Measured: baseline, 4 months
Change in the phosphorylation of the insulin receptor in adipocytes at 4 months
Measured: baseline, 4 months
Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months
Measured: baseline, 4 months
Number of Participants with Serious and Non-Serious Adverse Events
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionMay 2014 (estimated)
- Study completionMay 2014 (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 ObesityStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital General de Mexico
- Responsible party
- Sponsor
- Investigators
- Nayely G Garibay, Pediatrician, Principal investigator, Hospital General de MéxicoGloria E Queipo, M.Specialist, Principal investigator, Hospital General de México
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063802
- Sponsor's protocol ID
- DI/11/311/04/108
- Status last verified
- Feb 2014
- First submitted
- 12 Feb 2014
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Garibay-Nieto N, Queipo-Garcia G, Alvarez F, Bustos M, Villanueva E, Ramirez F, Leon M, Laresgoiti-Servitje E, Duggirala R, Macias T, Cuevas S, Jalife A, Fonseca-Sanchez M, Serratos F, Lopez-Alvarenga JC. Effects of Conjugated Linoleic Acid and Metformin on Insulin Sensitivity in Obese Children: Randomized Clinical Trial. J Clin Endocrinol Metab. 2017 Jan 1;102(1):132-140. doi: 10.1210/jc.2016-2701.
PubMed 27778642
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Intervention Program With Healthy Habits Plus Metformin or Conjugated Linoleic Acid Over Clinical Parameters and Molecular Pathways of Insulin Resistance in Obese Pediatric Patients
- ClinicalTrials.gov ID
- NCT02063802
- Acronym / sponsor ID
- DI/11/311/04/108
- Conditions
- Obesity
- Keywords
- pediatric obesity, conjugated linoleic acid, CLA, metformin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laboratorios Silanes S.A. de C.V.Industry (pharma, biotech, devices)
- Collaborators
- Hospital General de Mexico
- Study start
- Aug 2012
- Primary completion
- May 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 14 Feb 2014 (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 purpose of this clinical trial is to examine the effects of conjugated linoleic acid (CLA) vs metformin along with an intervention program with healthy habits on body composition, weight, M value in CLAMP and clinical laboratory values, as well as molecular and genetic changes in obese children.
Patients from the pediatric service of the Hospital from 8 to 18 years old with a body mass index ≥ Pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| metformin and healthy habits program | Active comparator | Drug: metformin, Behavioral: Healthy habits program1 gr per day. (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months. |
| Conjugated Linoleic Acid and healthy habits | Experimental | Dietary Supplement: Conjugated Linoleic Acid, Behavioral: Healthy habits programTotal dose: 3gr per day (500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner by mouth for four months. |
| Placebo and healthy habits program | Placebo comparator | Drug: Placebo, Behavioral: Healthy habits programTotal dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Patients of both sexes between 8 and 18 years old
- Pc BMI ≥ 95 and <35kg/m2,
- No endocrine diseases, including diabetes mellitus
- No systemic diseases
- No genetic diseases
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| metformintotal dose: 1 gr per day (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months. | Drug | metformin and healthy habits program |
| Conjugated Linoleic Acidtotal dose: 3gr/día(500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner for four months. | Dietary supplement | Conjugated Linoleic Acid and healthy habits |
| PlaceboTotal dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months | Drug | Placebo and healthy habits program |
| Healthy habits program | Behavioural | Conjugated Linoleic Acid and healthy habits, Placebo and healthy habits program, metformin and healthy habits program |
Primary outcome
Change from baseline in body mass index at 4 months
Time frame: baseline, 4 months
Change in body fat mass at 4 months
Time frame: baseline, 4 months
Change in lean body mass at 4 months
Time frame: baseline, 4 months
9 secondary outcomes
Change in clinical laboratory values at 4 months
Time frame: baseline, 4 months
Change in M Value in CLAMP at 4 months
Time frame: baseline, 4 months
Change in muscle tissue transcriptome at 4 months
Time frame: baseline, 4 months
Change in adipose tissue transcriptome at 4 months
Time frame: baseline, 4 months
Change in inflammatory cytokines al 4 months
Time frame: baseline, 4 months
Change in the phosphorylation of the insulin receptor in muscle tissue at 4 months
Time frame: baseline, 4 months
Change in the phosphorylation of the insulin receptor in adipocytes at 4 months
Time frame: baseline, 4 months
Change in activation status of proteins involved in insulin signaling of myocytes cDNA at 4 months
Time frame: baseline, 4 months
Number of Participants with Serious and Non-Serious Adverse Events
Time frame: up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
- Derived from this study: PubMed 27778642Garibay-Nieto N, Queipo-Garcia G, Alvarez F, Bustos M, Villanueva E, Ramirez F, Leon M, Laresgoiti-Servitje E, Duggirala R, Macias T, Cuevas S, Jalife A, Fonseca-Sanchez M, Serratos F, Lopez-Alvarenga JC. Effects of Conjugated Linoleic Acid and Metformin on Insulin Sensitivity in Obese Children: Randomized Clinical Trial. J Clin Endocrinol Metab. 2017 Jan 1;102(1):132-140. doi: 10.1210/jc.2016-2701.
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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.
Nayely G Garibay, Pediatrician principal investigator
Hospital General de México
Gloria E Queipo, M.Specialist principal investigator
Hospital General de México
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing metformin, Conjugated Linoleic Acid and Healthy habits program in people with Obesity, run by Laboratorios Silanes S.A. de C.V. 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 9 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 14 Feb 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge A Gonzalez, Director (521 (55)54883761 ext. 3761, jogonzalez@silanes.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in body mass index at 4 months (time frame: baseline, 4 months). The study lists 3 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 NCT02063802, 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 14 Feb 2014.