Trial · NCT00362440
Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
NCT00362440, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2017-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome. Trials, record NCT00362440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00362440
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Combination of Insulin Sensitizer and Leptin as Treatment for the HAART -Induced Metabolic Syndrome
- NCT number
- NCT00362440
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 9 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- HIV Lipodystrophy
- Interventions
- Leptin, Pioglitazone or metformin, Placebo
- First posted
- 2006-08-10
- Last updated
- 2017-03-23
- Results first posted
- 2017-03-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Insulin Resistance (HOMA Index) | At the end of each 3 month intervention | |
| Secondary | Cholesterol Levels | At the end of each 3 month intervention | |
| Secondary | Body Composition (Fat Mass) | At the end of each 3 month intervention |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Insulin Resistance (HOMA Index) | At the end of each 3 month intervention | units on a scale | MEAN | |
| SECONDARY | Cholesterol Levels | At the end of each 3 month intervention | mg/dl | MEAN | |
| SECONDARY | Body Composition (Fat Mass) | At the end of each 3 month intervention | kg | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Insulin Resistance (HOMA Index) | Leptin | 1.6 | Standard Error 0.5 | units on a scale | |
| Insulin Resistance (HOMA Index) | Pioglitazone or Metformin | 1.8 | Standard Error 0.8 | units on a scale | |
| Cholesterol Levels | Leptin | 190 | Standard Error 13 | mg/dl | |
| Cholesterol Levels | Pioglitazone or Metformin | 183 | Standard Error 17 | mg/dl | |
| Body Composition (Fat Mass) | Leptin | 16.7 | Standard Error 1.7 | kg | |
| Body Composition (Fat Mass) | Pioglitazone or Metformin | 13.1 | Standard Error 0.8 | kg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Leptin | 5 | |
| Overall Study | STARTED | Pioglitazone or Metformin | 4 | |
| Overall Study | COMPLETED | Leptin | 3 | |
| Overall Study | COMPLETED | Pioglitazone or Metformin | 3 | |
| Overall Study | NOT COMPLETED | Leptin | 2 | |
| Overall Study | NOT COMPLETED | Pioglitazone or Metformin | 1 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Leptin | 1 | 5 | 1 |
| other | Injection site reaction | Skin and subcutaneous tissue disorders | Pioglitazone or Metformin | 1 | 4 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Leptin | ||
| Total, all-cause mortality | Pioglitazone or Metformin | ||
| Total, other adverse events | Leptin | 1 | 5 |
| Total, other adverse events | Pioglitazone or Metformin | 1 | 4 |
| Total, serious adverse events | Leptin | 0 | 5 |
| Total, serious adverse events | Pioglitazone or Metformin | 0 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 16636130 | BACKGROUND |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Leptin vs Pioglitazone or Metformin: serious adverse events |
Source Trial comparisons
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/NCT00362440
GET https://conductscience.org/api/trials/v1/NCT00362440/registered