Trial · NCT04298203
Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity
NCT04298203, Phase 2, Completed, University of Minnesota
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity. Trials, record NCT04298203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04298203
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Role of Pharmacotherapy in Counteracting Weight Regain in Adolescents With Severe Obesity
- NCT number
- NCT04298203
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- University of Minnesota
- Conditions
- Obesity
- Interventions
- Phentermine-Topiramate, Meal Replacement Therapy, Placebo
- First posted
- 2020-03-06
- Last updated
- 2026-05-26
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To measure changes in BMI. | 58 weeks. | The investigators will measure the change in BMI reduction during the meal replacement therapy intervention as well as during the treatment with phentermine/topiramate or placebo. Weight and height will be combined to report BMI in kg/m\^2 |
| Primary | To measure changes in total body fat | iDXA will be conducted at four timepoints (Baseline, 1 day of Randomization, Week 26 and Week 52). | The investigators will measure the change in total body fat during the meal replacement therapy intervention and during the treatment with phentermine/topiramate or placebo via use of dual-energy x-ray absorptiometry (iDXA). |
| Primary | To measure changes in visceral fat. | iDXA will be conducted at four timepoints (Baseline, 1 day of Randomization, Week 26 and Week 52). | The investigators will measure the change in visceral fat during the meal replacement therapy intervention and during the treatment with phentermine/topiramate or placebo via use of the iDXA. |
| Primary | To measure changes in lipids. | Baseline, 1 day of Randomization, Week 26 and Week 52 visits. | Lipids (consisting of total lipids, LDL, HDL, cholesterol and triglycerides) |
| Primary | To measure changes in glucose. | Baseline, 1 day of Randomization, Week 26 and Week 52 visits. | The investigators will track whether fasting glucose levels come down during the course of participation in the study. Glucose can be an indicator of diabetes. Typical fasting glucose ranges for individuals 6 months and older are approximately 70-99 mg/dL. Investigators will track whether glucose levels reduce during the course of the study. |
| Primary | To measure changes in insulin. | Baseline, 1 day of Randomization, Week 26 and Week 52 visits. | Investigators will track whether insulin levels reduce during the course of the study. |
| Primary | To measure changes in hemoglobin A1c. | Baseline, 1 day of Randomization, Week 26 and Week 52 visits. | Investigators will track whether hemoglobin A1c levels (which can indicate pre-diabetes or diabetes) decrease during the course of the study. Normal ranges for hemoglobin A1c are less than 5/7%. Prediabetes ranges are 5.7-7.5% and diabetes ranges are 6.5% or greater. |
| Primary | To measure changes in C-reactive protein (CRP). | Baseline, 1 day of Randomization, Week 26 and Week 52 visits. | C-reactive protein tests help to measure cardiac risk. Investigators will review C-reactive protein levels during the study to see if they decrease. Normal ranges for CRP are: \<1 mg/L for low risk, 1.0-3.0 mg/L for average risk, \>3.0 mg/L for high risk and \> 10.0 mg/L for acute inflammation. |
| Primary | To measure changes in oxidized LDL. | Baseline, 1 day of Randomization, Week 26 and Week 52 visits. | Investigators will measure changes in oxidized low-density lipoprotein. Oxidized LDL is a potentially harmful cholesterol that is produced in the body when normal LDL cholesterol is damaged by chemical interactions. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04298203
GET https://conductscience.org/api/trials/v1/NCT04298203/registered