Comparison · NCT02515773-sae
MET and LIFE vs Healthy Lifestyle Intervention (LIFE): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. MET and LIFE vs Healthy Lifestyle Intervention (LIFE): serious adverse events. Trial comparisons, record NCT02515773-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02515773-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0207 | 0.0119 | 0.0359 | wilson | |
| Risk in group 2 | 0.0347 | 0.0236 | 0.0508 | wilson | |
| Risk difference, group 1 minus group 2 | -0.014 | -0.0323 | 0.00478 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.597 | 0.303 | 1.18 | log | |
| Odds ratio, group 1 over group 2 | 0.588 | 0.293 | 1.18 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on MET and LIFE than on Healthy Lifestyle Intervention (LIFE) | 71.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | MET and LIFE | Participants randomized to this group will receive both Metformin and lifestyle intervention.Participants randomized to treatment with MET will start at a dose of 500 mg orally at night and slowly titrated in 2-week intervals to ensure that each patient achieves maximum insulin-sensitizing effects of the drug while minimizing the chance of side effects. Investigators will also recommend that MET be taken with food to minimize side effects. If a participant's BMI percentile \<5% (=underweight) his/her treatment with MET will be discontinued. Although the risk of low vitamin B12 while taking MET is associated with age \> 50 years and having type II diabetes, Investigator will monitor B12 levels and a CBC throughout study participation.~Metformin: Metformin - to achieves maximum insulin-sensitizing effects~healthy lifestyle intervention (LIFE): Healthy Life style intervention | 12 | 579 | EG000 |
| Group 2 | Healthy Lifestyle Intervention (LIFE) | Participants randomized to this group will receive just lifestyle intervention alone.This healthy lifestyle intervention (LIFE) consists of counseling participants and families regarding a healthy eating plan, physical activity and sedentary activities. Prior to study initiation, clinical site staff will participate in a live (or taped) training session from a dietician to lean to administer LIFE. A trained site staff member (e.g. medical assistant or case manager) will meet with participants and their families for a 15-20 minute session at baseline that will focus on nutritional issues using the Traffic Light Plan (TLP).~healthy lifestyle intervention (LIFE): Healthy Life style intervention | 25 | 720 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 30 months
Source ClinicalTrials.gov
Trial
- Title
- Metformin for Overweight & OBese ChILdren and Adolescents With BDS Treated With SGAs
- NCT number
- NCT02515773
- Phases
- PHASE4
- Conditions
- Bipolar Disorder
- Interventions
- Metformin, healthy lifestyle intervention (LIFE)
- Lead sponsor
- Melissa Delbello
- Results first posted
- 2025-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02515773?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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