Trial · NCT01351753
Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
NCT01351753, Phase 2, Terminated, University of Iowa; results first posted 2021-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity. Trials, record NCT01351753. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01351753
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Drug Therapy Induced Weight Loss to Improve Blood Vessel Function in Subjects With Obesity
- NCT number
- NCT01351753
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 128 participants, actual
- Lead sponsor
- University of Iowa
- Conditions
- Obesity, Metabolic Syndrome X
- Interventions
- Metformin, Orlistat, Topiramate, Placebo
- First posted
- 2011-05-11
- Last updated
- 2026-03-12
- Results first posted
- 2021-06-09
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Weight (Percent Change From Baseline) | Baseline and 6 months | Weight obtained in the fasting state on a gowned subject. |
| Secondary | Office Systolic Blood Pressure (mmHg Change From Baseline) | Baseline and 6 months | Automated sphygmomanometry while sitting |
| Secondary | Centimeter Change in Waist Circumference | Baseline and 6 months | Waist circumference for central adiposity |
| Secondary | Carotid-femoral Pulse Wave Velocity (PWV)(Change After 6 Months From Baseline) | Baseline and 6 months | Change in carotid-femoral pulse wave velocity in meters/second (Sphygmocor). |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Weight (Percent Change From Baseline) | Baseline and 6 months | percentage of weight change | MEAN | |
| SECONDARY | Office Systolic Blood Pressure (mmHg Change From Baseline) | Baseline and 6 months | mmHg | MEAN | |
| SECONDARY | Centimeter Change in Waist Circumference | Baseline and 6 months | cm change | MEAN | |
| SECONDARY | Carotid-femoral Pulse Wave Velocity (PWV)(Change After 6 Months From Baseline) | Baseline and 6 months | meters/sec | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Weight (Percent Change From Baseline) | Metformin | -10.9 | 95% Confidence Interval -14.4 to -7.2 | percentage of weight change | |
| Weight (Percent Change From Baseline) | Metformin + Orlistat | -10.5 | 95% Confidence Interval -14.0 to -6.9 | percentage of weight change | |
| Weight (Percent Change From Baseline) | Metformin + Topiramate | -14.0 | 95% Confidence Interval -17.3 to -10.5 | percentage of weight change | |
| Weight (Percent Change From Baseline) | Topiramate | -12.2 | 95% Confidence Interval -15.6 to -8.6 | percentage of weight change | |
| Weight (Percent Change From Baseline) | Metformin + Topiramate + Orlistat | -16.7 | 95% Confidence Interval -20.3 to -13.0 | percentage of weight change | |
| Weight (Percent Change From Baseline) | Placebo | -6.7 | 95% Confidence Interval -10.5 to -2.7 | percentage of weight change | |
| Office Systolic Blood Pressure (mmHg Change From Baseline) | Metformin | -11.42 | 95% Confidence Interval -21.10 to -1.74 | mmHg | |
| Office Systolic Blood Pressure (mmHg Change From Baseline) | Metformin + Orlistat | -11.41 | 95% Confidence Interval -20.88 to -1.94 | mmHg | |
| Office Systolic Blood Pressure (mmHg Change From Baseline) | Metformin + Topiramate | -10.33 | 95% Confidence Interval -19.52 to -1.14 | mmHg | |
| Office Systolic Blood Pressure (mmHg Change From Baseline) | Topiramate | -8.55 | 95% Confidence Interval -18.53 to 1.44 | mmHg |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin | 22 | |
| Overall Study | STARTED | Metformin + Orlistat | 20 | |
| Overall Study | STARTED | Metformin + Topiramate | 21 | |
| Overall Study | STARTED | Topiramate | 21 | |
| Overall Study | STARTED | Metformin + Topiramate + Orlistat | 21 | |
| Overall Study | STARTED | Placebo | 23 | |
| Overall Study | COMPLETED | Metformin | 15 | |
| Overall Study | COMPLETED | Metformin + Orlistat | 13 | |
| Overall Study | COMPLETED | Metformin + Topiramate | 14 | |
| Overall Study | COMPLETED | Topiramate | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin | ||
| Total, all-cause mortality | Metformin + Orlistat | ||
| Total, all-cause mortality | Metformin + Topiramate | ||
| Total, all-cause mortality | Topiramate | ||
| Total, all-cause mortality | Metformin + Topiramate + Orlistat | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Metformin | 0 | 22 |
| Total, other adverse events | Metformin + Orlistat | 0 | 20 |
| Total, other adverse events | Metformin + Topiramate | 0 | 21 |
| Total, other adverse events | Topiramate | 0 | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39952695 | DERIVED |
Source PubMed
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/NCT01351753
GET https://conductscience.org/api/trials/v1/NCT01351753/results?page=2