ObesityPhase 3OCANCT01677923
Obesity in Children and Adolescents: Associated Risks and Early Intervention
A Phase 3 study testing Metformin in people with Obesity, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial summary
The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and increases insulin sensitivity; the study team hope to get better effect of weight decrease and metabolic processes repair in the intensive treatment group with intervention of physical activity, diet correction and Metformin… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Obesity
- What is being tested?
- Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteLithuania
- Study dates
- May 2013to Dec 2015
- Phase
- Phase 3
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10-17 yrs;
- Weight > 85th percentile for age and gender (by IOTF);
- Living in Kaunas and its region;
- No obvious chronic diseases;
- Not on steroid or other long-term treatment;
- Informed consent of the patient and parents (official caregivers);
Who cannot join
- Age less than 10 or above 17 yrs;
- Diagnosis of type 1 diabetes;
- Chronic illness that may affect physical activity and metabolic profile;
- Insulin treatment;
- Steroid treatment;
- Planning to move from Kaunas or its region in the period of 1 year;
- Protocol refused by the patient or his parents;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.
The investigators hypothesize that Metformin decreases weight, normalizes lipid profile and increases insulin sensitivity; the study team hope to get better effect of weight decrease and metabolic processes repair in the intensive treatment group with intervention of physical activity, diet correction and Metformin use.
Read the detailed description
During the first visit, study participants would follow the clinical investigation (anthropometry, physical examination, blood tests (hormonal and biochemical state), bioimpedance, ultrasound evaluation) and be attributed into 4 groups (matched for age, gender, pubertal stage and BMI), 100 subjects in each group.
- st group - control: during the first visit patients get standardized information on healthy lifestyle, diet and exercise. Next visit (control) will be scheduled for the clinical and laboratory evaluation after 12 months of intervention.
- nd group - intensive diet and physical activity group: Children will be seen
- by a dietician once a month for diet re-evaluation;
- physical therapist, who will give physical activity course twice a week (1 h each).
- pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention.
- rd group - intensive diet and physical activity group plus insulin sensitization: Metformin will be prescribed for this group of study children in the doses of 1000 mg/day Children will be seen by
- a dietician once a month for diet re-evaluation;
- physical therapist, who will give physical activity course twice a week (1 h each);
- pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention.
- th group- insulin sensitization without intensive diet and physical activity. Metformin will be prescribed in the doses of 1000 mg/day after standardized information on healthy lifestyle, diet and exercise during the first visit only. This group of children will be seen by pediatric endocrinologist every 3 months.
Intervention duration - 12 months. In the case of Metformin intolerance, children will continue the study in 2nd group.
Clinical and laboratory evaluation after 12 months of intervention.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Metforal
Metformin 500 mg BID for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Control without Metformin | No intervention | Conventional management of obesity including basic instructions on diet and physical activity |
| Control with Metformin | Experimental | Conventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment Receives: Drug: Metformin |
| Intervention with Metformin | Experimental | Intensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment. Receives: Drug: Metformin |
| Intervention without Metformin | No intervention | Intensive physical activity course twice per week and monthly diet control by dietitian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body mass index changes
decrease in body mass index
Measured: 12 months
Secondary outcomes (5)
Glucose homeostasis
Insulin sensitivity increase, homeostasis model assessment (HOMA-IR) decrease, insulin and glucose concentrations normalisation
Measured: 12 month
Lipid profile
Lipid profile normalisation
Measured: 12 months
Metabolic syndrome
Metabolic syndrome prevalence and risks decrease
Measured: 12 months
Hepatosteatosis
Hepatosteatosis prevalence decrease and liver function improvement, hepatic enzymes normalisation
Measured: 12 months
Polycystic ovary syndrome (PCOS) and hyperandrogenism in females
PCOS clinical symptoms regression, menstrual cycle normalisation, hirsutism, androgens levels decreasing and estrogen, sex hormone-binding globulin (SHBG) levels increasing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startMay 2013
- Primary completionApr 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasa Verkauskiene, Lithuanian University of Health Sciences
- Investigators
- Rasa Verkauskiene, Professor, Study chair, Lithuanian University of Health Sciences Hospital, Endocrinology Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677923
- Sponsor's protocol ID
- BE-2-1
- Acronym
- OCA
- Status last verified
- Mar 2016
- First submitted
- 30 Jul 2012
- Last updated
- 4 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided: Study results are in progress with statistical analysis
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3: Effect of Diet, Physical Activity and Insulin Sensitizer Metformin on Obesity and Associated Risks in Children and Adolescents.
- ClinicalTrials.gov ID
- NCT01677923
- Acronym / sponsor ID
- OCA / BE-2-1
- Conditions
- Obesity
- Keywords
- weight, body mass index, lipid profile, glucose profile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Sep 2012 (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 investigators hypothesize that Metformin decreases weight, normalizes lipid profile and increases insulin sensitivity; the study team hope to get better effect of weight decrease and metabolic processes repair in the intensive treatment group with intervention of physical activity, diet correction and Metformin use.
Detailed description
During the first visit, study participants would follow the clinical investigation (anthropometry, physical examination, blood tests (hormonal and biochemical state), bioimpedance, ultrasound evaluation) and be attributed into 4 groups (matched for age, gender, pubertal stage and BMI), 100 subjects in each group.
- st group - control: during the first visit patients get standardized information on healthy lifestyle, diet and exercise. Next visit (control) will be scheduled for the clinical and laboratory evaluation after 12 months of intervention.
- nd group - intensive diet and physical activity group: Children will be seen
- by a dietician once a month for diet re-evaluation;
- physical therapist, who will give physical activity course twice a week (1 h each).
- pediatric endocrinologist every 3 months. Clinical and laboratory evaluation after 12 months of intervention.
- rd group - intensive diet and physical activity group plus insulin sensitization: Metformin will be prescribed for this group of study children in the doses of 1000 mg/day Children will be seen by
- a dietician once a month for diet re-evaluation;
- physical therapist, who will give physical activity course twice a week (1 h each);
- pediatric endocrinologist every 3 month. Clinical and laboratory evaluation after 12 months of intervention.
- th group- insulin sensitization without intensive diet and physical activity. Metformin will be prescribed in the doses of 1000 mg/day after standardized information on healthy lifestyle, diet and exercise during the first visit only. This group of children will be seen by pediatric endocrinologist every 3 months.
Intervention duration - 12 months. In the case of Metformin intolerance, children will continue the study in 2nd group.
Clinical and laboratory evaluation after 12 months of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control without Metformin | No intervention | –Conventional management of obesity including basic instructions on diet and physical activity |
| Control with Metformin | Experimental | Drug: MetforminConventional management of obesity including basic instructions on diet and physical activity plus Metformin treatment |
| Intervention with Metformin | Experimental | Drug: MetforminIntensive physical activity course twice per week and monthly diet control by dietitian plus Metformin treatment. |
| Intervention without Metformin | No intervention | –Intensive physical activity course twice per week and monthly diet control by dietitian |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age 10-17 yrs;
- Weight > 85th percentile for age and gender (by IOTF);
- Living in Kaunas and its region;
- No obvious chronic diseases;
- Not on steroid or other long-term treatment;
Key exclusion criteria (7 listed)
- Age less than 10 or above 17 yrs;
- Diagnosis of type 1 diabetes;
- Chronic illness that may affect physical activity and metabolic profile;
- Insulin treatment;
- Steroid treatment;
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 |
|---|---|---|
| MetforminAlso: MetforalMetformin 500 mg BID for 12 months | Drug | Control with Metformin, Intervention with Metformin |
Primary outcome
Body mass index changes
Time frame: 12 months
decrease in body mass index
5 secondary outcomes
Glucose homeostasis
Time frame: 12 month
Lipid profile
Time frame: 12 months
Metabolic syndrome
Time frame: 12 months
Hepatosteatosis
Time frame: 12 months
Polycystic ovary syndrome (PCOS) and hyperandrogenism in females
Time frame: 12 months
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 4 Mar 2016.
- Individual participant dataSharing planned: Undecided. Study results are in progress with statistical analysis
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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.
Rasa Verkauskiene, Professor study chair
Lithuanian University of Health Sciences Hospital, Endocrinology Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Metformin in people with Obesity, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 7 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 4 Mar 2016. 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 Lithuania. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Body mass index changes (time frame: 12 months). 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 4 Mar 2016.