Trial · NCT00063232
Treating Nonalcoholic Steatohepatitis (NASH) With Metformin
NCT00063232, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2011-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treating Nonalcoholic Steatohepatitis (NASH) With Metformin. Trials, record NCT00063232. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00063232
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treating Nonalcoholic Steatohepatitis (NASH) With Metformin
- NCT number
- NCT00063232
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Hepatitis
- Interventions
- Metformin
- First posted
- 2003-06-24
- Last updated
- 2011-07-20
- Results first posted
- 2011-07-20
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category) | from baseline to 48 Weeks | Patients under went liver biopsy, metabolic profiling and imaging studies before and at the end 48 weeks of metformin (2000 mg/day) therapy. The primary endpoint is a three point improvement in the histological NASH activity index with a decrease in at least two of the component scores and no worsening of fibrosis or increase in Mallory bodies. |
| Secondary | Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category) | from baseline to 48 weeks | Alanine transaminase \<42 U/L is considered normal |
| Secondary | Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline | from baseline to 48 weeks | HOMA-IR is calculated from Fasting Glucose and Fasting Insulin |
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 | Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category) | from baseline to 48 Weeks | participants | NUMBER | |
| SECONDARY | Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category) | from baseline to 48 weeks | participants | NUMBER | |
| SECONDARY | Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline | from baseline to 48 weeks | unit | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category) | Metformin | improved (reduced) by greater or equal to 3 points | 9 | participants | |
| Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category) | Metformin | improved (reduced) by 1-2 points | 11 | participants | |
| Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category) | Metformin | no change | 5 | participants | |
| Change in the Histological NASH Activity Index at 48 Weeks Compared With Baseline (Number of Participants in Each Change Category) | Metformin | worsen (increased) | 1 | participants | |
| Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category) | Metformin | changed to normal from abnormal | 9 | participants | |
| Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category) | Metformin | unchanged (normal at beginning) | 4 | participants | |
| Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category) | Metformin | unchanged (abnormal at beginning) | 12 | participants | |
| Change in Serum Alanine Aminotransferase (ALT) Levels From Baseline (Number of Participants in Each Change Category) | Metformin | changed to abnormal from normal | 1 | participants | |
| Change in Insulin Sensitivity (Glucose Tolerance, Homeostatic Model Assessment of Insulin Resistence (HOMA-IR)) From Baseline | Metformin | -3.3 | Standard Deviation 3.2 | unit |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metformin | 26 | |
| Overall Study | COMPLETED | Metformin | 26 | |
| Overall Study | NOT COMPLETED | Metformin | 0 |
Source ClinicalTrials.gov
Adverse events1
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 | Weight loss | General disorders | Metformin | 21 | 26 | 21 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metformin | ||
| Total, other adverse events | Metformin | 21 | 26 |
| Total, serious adverse events | Metformin | 0 | 26 |
Source ClinicalTrials.gov
Papers2
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/NCT00063232
GET https://conductscience.org/api/trials/v1/NCT00063232/registered