Trial · NCT00618072
EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
NCT00618072, Phase 2, Completed, New York Medical College; results first posted 2014-03-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance. Trials, record NCT00618072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00618072
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- EMPOWIR:Enhance the Metabolic Profile of Women With Insulin Resistance
- NCT number
- NCT00618072
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- New York Medical College
- Conditions
- Hyperinsulinemia, Insulin Resistance, Obesity
- Interventions
- metformin and rosiglitazone
- First posted
- 2008-02-18
- Last updated
- 2014-03-28
- Results first posted
- 2014-03-28
- Limitations and caveats
Widespread media coverage of cardiovascular risks of rosiglitazone led to an unanticipated high drop out rate of subjects just prior to their randomization; 22 of 68 eligible subjects did not undergo randomization due to concerns about the drug.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Fasting Insulin | 6 months | Insulin was determined with a Siemens Immulite assay with respective intra-and inter-CV's 5.7 and 5.9%, and no cross reactivity to pro-insulin. |
| Secondary | Body Weight | 6 months | Body weight measurement was performed three times and averaged by a single study coordinator. |
| Secondary | HOMA-IR | 6 months | HOMA-IR was calculated by the formula: fasting insulin (uU/mL) times fasting glucose (mg/L) divided by 22.5. |
| Secondary | Waist Circumference | 6 months | |
| Secondary | Systolic BP | 6 months | Blood pressure was assessed using NCEP guidelines. |
| Secondary | Diastolic BP | 6 months | Blood pressure was assessed using NCEP guidelines. |
| Secondary | HDL | 6 months | HDL was measured using two reagents homogeneous systems with selective detergents to homogenize the lipoprotein of interest. |
| Secondary | Triglycerides | 6 months | Triglycerides were measured by enzymatic immunoassay on an AU400 chemistry auto-analyzer with commercially available enzymatic reagents. |
| Secondary | Adiponectin | 6 months | Total adiponectin was measured with a commercial ELISA kit (Millipore/Linco Research, St. Charles, MO) in the laboratory of Dr. Philipp Scherer. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Fasting Insulin | 6 months | The final data-set consisted of 44 study participants, after exclusion of two study completers due to clinical conditions which appeared de novo (asthma requiring high dose prednisone and growth hormone deficiency diagnosed mid-study) - applicable to all study outcomes. | uIU/mL | MEAN |
| SECONDARY | Body Weight | 6 months | kg | MEAN | |
| SECONDARY | HOMA-IR | 6 months | HOMA-IR score | MEAN | |
| SECONDARY | Waist Circumference | 6 months | cm | MEAN | |
| SECONDARY | Systolic BP | 6 months | mmHg | MEAN | |
| SECONDARY | Diastolic BP | 6 months | mmHg | MEAN | |
| SECONDARY | HDL | 6 months | mg/dl | MEAN | |
| SECONDARY | Triglycerides | 6 months | mg/dl | MEAN | |
| SECONDARY | Adiponectin | 6 months | ug/mL | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Fasting Insulin | A: EMPOWIR Diet and Placebo | 8.1 | Standard Error 1.3 | uIU/mL | |
| Fasting Insulin | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 8.0 | Standard Error 1.2 | uIU/mL | |
| Fasting Insulin | C: EMPOWIR Diet Plus Metformin and Avandia | 6.3 | Standard Error 0.9 | uIU/mL | |
| Body Weight | A: EMPOWIR Diet and Placebo | 80.0 | Standard Error 2.7 | kg | |
| Body Weight | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 80.4 | Standard Error 2.1 | kg | |
| Body Weight | C: EMPOWIR Diet Plus Metformin and Avandia | 77.5 | Standard Error 4.0 | kg | |
| HOMA-IR | A: EMPOWIR Diet and Placebo | 1.5 | Standard Error 0.1 | HOMA-IR score | |
| HOMA-IR | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 1.6 | Standard Error 0.3 | HOMA-IR score | |
| HOMA-IR | C: EMPOWIR Diet Plus Metformin and Avandia | 1.3 | Standard Error 0.2 | HOMA-IR score | |
| Waist Circumference | A: EMPOWIR Diet and Placebo | 93.1 | Standard Error 2.1 | cm |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A: EMPOWIR Diet and Placebo | 16 | |
| Overall Study | STARTED | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 15 | |
| Overall Study | STARTED | C: EMPOWIR Diet Plus Metformin and Avandia | 15 | |
| Overall Study | COMPLETED | A: EMPOWIR Diet and Placebo | 14 | |
| Overall Study | COMPLETED | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 14 | |
| Overall Study | COMPLETED | C: EMPOWIR Diet Plus Metformin and Avandia | 11 | |
| Overall Study | NOT COMPLETED | A: EMPOWIR Diet and Placebo | 2 | |
| Overall Study | NOT COMPLETED | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 1 | |
| Overall Study | NOT COMPLETED | C: EMPOWIR Diet Plus Metformin and Avandia | 4 |
Source ClinicalTrials.gov
Adverse events3
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 |
|---|---|---|---|---|---|---|
| serious | Worsening of Hypertension | Cardiac disorders | A: EMPOWIR and Placebo | 1 | 16 | 1 |
| serious | Worsening of Hypertension | Cardiac disorders | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 0 | 15 | 0 |
| serious | Worsening of Hypertension | Cardiac disorders | C: EMPOWIR Diet Plus Metformin and Avandia | 0 | 15 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: EMPOWIR and Placebo | ||
| Total, all-cause mortality | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | ||
| Total, all-cause mortality | C: EMPOWIR Diet Plus Metformin and Avandia | ||
| Total, other adverse events | A: EMPOWIR and Placebo | 0 | 16 |
| Total, other adverse events | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 0 | 15 |
| Total, other adverse events | C: EMPOWIR Diet Plus Metformin and Avandia | 0 | 15 |
| Total, serious adverse events | A: EMPOWIR and Placebo | 1 | 16 |
| Total, serious adverse events | B: EMPOWIR Diet Plus Metformin and Placebo Avandia | 0 | 15 |
| Total, serious adverse events | C: EMPOWIR Diet Plus Metformin and Avandia | 0 | 15 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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/NCT00618072
GET https://conductscience.org/api/trials/v1/NCT00618072/results?page=2