Nonalcoholic SteatohepatitisPhase 4NCT00227110
Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
A Phase 4 study testing Pioglitazone in people with Nonalcoholic Steatohepatitis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- Pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jan 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
- Patients must have an age range between 21 to 70 years (inclusive).
- NASH confirmed by liver biopsy.
- Subjects must meet the criteria for impaired glucose tolerance (FPG concentration <126 mg/dl and a two hour plasma glucose value during the oral glucose tolerance test [OGTT] ≥140 but <200 mg/dl) or type 2 diabetes mellitus (FPG concentration ≥ 126 mg/dl or a two hour plasma glucose value during the OGTT ≥200 mg/dl) (62). Subjects with a FPG greater than 260 mg/dl will be excluded from the study.
- Diabetic patients will be allowed to be on sulfonylureas or repaglinide but not on metformin, a thiazolidinedione or insulin. Patients must have been on a stable dose of allowed chronic medications for four weeks prior to entering the double-blind treatment period.
- Female patients must be non-lactating and must either be at least two years post-menopausal, or be using adequate mechanical contraceptive precautions (i.e. intrauterine device, diaphragm with spermicide, condom with spermicide), or be surgically sterilized (i.e. bilateral tubal ligation, bilateral oophorectomy). Female patients who have undergone a hysterectomy are eligible for participation in the study. Female patients (except for those patients who have undergone a hysterectomy or a bilateral oophorectomy) are eligible only if they have a negative pregnancy test throughout the study period. Patients on oral contraceptives or an hormonal implant will be excluded.
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- All participants must have the following laboratory values:
- Hemoglobin ≥ 13 gm/dl in males, or
- ≥ 12 gm/dl in females WBC count ≥ 3,000/mm3 Neutrophil count ≥ 1,500/mm3 Platelets ≥ 100,000/mm3 Prothrombin time within 3 seconds of control Albumin ≥3.0 g/dl Serum creatinine ≤ 1.6 mg/dl Creatinine phosphokinase ≤ 2 times upper limit of normal AST (SGOT) ≤ 2.5 times upper limit of normal ALT (SGPT) ≤ 2.5 times upper limit of normal Alkaline phosphatase ≤ 2.5 times upper limit of normal
Who cannot join
- Any cause of chronic liver disease other than NASH (such as -but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency).
- Any clinical evidence or history of ascitis, bleeding varices, or spontaneous encephalopathy.
- No past (for at least for 1 year) or current history of alcohol abuse (alcohol consumption greater than one drink per day).
- Prior surgical procedures to include gastroplasty, jejuno-ileal or jejunocolic bypass.
- Prior exposure to organic solvents such as carbon tetrachloride.
- Total parenteral nutrition (TPN) within the past 6 months.
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- Diabetics with a FPG greater than 260 mg/dl on initial visit.
- Diabetics who are taking metformin, a thiazolidinedione or insulin.
- Subjects with type 1 diabetes mellitus.
- Patients on chronic medications with known adverse effects on glucose tolerance levels unless the patient has been on a stable dose of such agents for 4 weeks before entry into the study. Patients on estrogens or other hormonal replacement therapy, tamoxifen, raloxifene, oral glucocorticoids or chloroquine will be excluded.
- Patients with a history of clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on EKG), peripheral vascular disease (history of claudication), or pulmonary disease (dyspnea on exertion of one flight or less; abnormal breath sounds on auscultation), will not be studied.
Trial locations and contacts
1 site in 1 country.
United States1 site
Audie L Murphy VA Hospital
San Antonio, Texas, 78229
About this study
To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).
Read the detailed description
- 4/1/2003 Role of Pioglitazone in the Treatment of Nonalcoholic Steatohepatitis
- PURPOSE/SPECIFIC AIMS To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM). NASH is a disease characterized by elevated plasma aminotransferases and histopathological changes in liver characterized by hepatocellular steatosis, chronic inflammation and fibrosis (1-3). Pioglitazone, a new thiazolidinedione (TZD), has proven to be safe and effective for the treatment of type 2 diabetes mellitus (T2DM) (4). NASH affects ~10-20% of obese and type 2 diabetic subjects (1-3, 5, 6). While the pathogenesis of NASH is poorly understood, there is consensus that insulin resistance and its associated abnormalities in lipid metabolism play a key role in the development of liver fat accumulation, and TNF-alpha is a major mediator in the progression of liver damage (7-9). Currently, there is no satisfactory therapy for NASH.
Pioglitazone improves insulin sensitivity and glycemic control in patients with T2DM (4, 10-12), but the mechanism of action of TZDs is unclear (13, 14). Pioglitazone activates genes involved in lipid synthesis, causing a reduction in plasma free fatty acid (FFA) and triglycerides (15). TZDs decrease excessive triglyceride accumulation in liver (16), muscle (17), and visceral fat (11, 16, 18), with a redistribution of fat to subcutaneous adipose stores (14). TZDs also antagonize the metabolic effects of TNF-alpha (19-22). Because pioglitazone ameliorates insulin resistance, reverses the metabolic abnormalities that contribute to hepatic fat infiltration (increased plasma glucose, FFA, and triglyceride concentrations), and antagonizes the effects of TNF-alpha, it follows that pioglitazone may prove useful for the treatment of patients with NASH.
In order to evaluate this hypothesis, we plan to treat for 6 months a group of patients with impaired glucose tolerance (IGT) or T2DM with pioglitazone in a randomized, double-blinded, placebo-controlled trial. Three major endpoints will be measured before and after treatment (see Methods for a detailed description):
- Liver histologic response; assessed by liver biopsy. Steatosis and inflammatory changes will be quantified using a standardized staging system.
- Liver fat content: measured by liver magnetic resonance spectroscopy (MRS).
- Hepatic insulin sensitivity and glucose metabolism: Because fat infiltration of liver and muscle causes insulin resistance and impairs glucose tolerance, we will measure parameters of metabolic control including fasting plasma glucose, free fatty acids, fructosamine, HbA1c and fasting lipid profile. To assess the effect of pioglitazone on hepatic insulin sensitivity, fasting (basal) and postprandial hepatic glucose production will be studied using a double-tracer technique (infusion of 3-3H glucose combined with an oral glucose load radiolabeled with 1-14C glucose) (23). Glucose and lipid oxidation will be measured by indirect calorimetry (24). In addition, an index of hepatic and peripheral insulin sensitivity will be derived from the oral glucose tolerance test (OGTT) (25).
- Conditions
- Nonalcoholic Steatohepatitis
- Being tested
- Pioglitazone, Placebo
- Keywords
- NASH, IGT, T2DM
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
Also called Actos (Takeda Pharmaceuticals).
30 mg/d for 8 weeks and titrated to 45 mg/d until completing 6 months of treatment.
PlaceboDrug
Placebo is given to match pioglitazone.
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Active comparator | Pioglitazone 30 mg/d will be given for 8 weeks and titrated to 45 mg/d until the end of the 6-month study in a randomized, double-blind, study design. Receives: Drug: Pioglitazone |
| Placebo | Placebo comparator | Placebo once daily is given following a randomized, double-blind, placebo-controlled study design. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver histology (Kleiner criteria, Hepatology 2005)
Measured: 6 months.
Secondary outcomes (2)
Liver fat content by MRS.
Measured: 6 months.
Double-tracer OGTT (EGP, glucose clearance).
Measured: 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startOct 2002
- Primary completionNov 2005
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Takeda Pharmaceuticals North America, Inc.
- Investigators
- Kenneth Cusi, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00227110
- Sponsor's protocol ID
- UTHSCSA IRB# 001-5014-331
- Status last verified
- Oct 2009
- First submitted
- 23 Sep 2005
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cusi K. Thiazolidinediones in NASH. An odd couple meant to be? J Clin Gastroenterol. 2009 Jul;43(6):503-5. doi: 10.1097/MCG.0b013e3181a15e51. No abstract available.
PubMed 19384246Belfort R, Harrison SA, Brown K, Darland C, Finch J, Hardies J, Balas B, Gastaldelli A, Tio F, Pulcini J, Berria R, Ma JZ, Dwivedi S, Havranek R, Fincke C, DeFronzo R, Bannayan GA, Schenker S, Cusi K. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med. 2006 Nov 30;355(22):2297-307. doi: 10.1056/NEJMoa060326.
PubMed 17135584Balas B, Belfort R, Harrison SA, Darland C, Finch J, Schenker S, Gastaldelli A, Cusi K. Pioglitazone treatment increases whole body fat but not total body water in patients with non-alcoholic steatohepatitis. J Hepatol. 2007 Oct;47(4):565-70. doi: 10.1016/j.jhep.2007.04.013. Epub 2007 May 24.
PubMed 17560678Gastaldelli A, Harrison SA, Belfort-Aguilar R, Hardies LJ, Balas B, Schenker S, Cusi K. Importance of changes in adipose tissue insulin resistance to histological response during thiazolidinedione treatment of patients with nonalcoholic steatohepatitis. Hepatology. 2009 Oct;50(4):1087-93. doi: 10.1002/hep.23116.
PubMed 19670459Ali R, Cusi K. New diagnostic and treatment approaches in non-alcoholic fatty liver disease (NAFLD). Ann Med. 2009;41(4):265-78. doi: 10.1080/07853890802552437.
PubMed 19353360Cusi K. Nonalcoholic fatty liver disease in type 2 diabetes mellitus. Curr Opin Endocrinol Diabetes Obes. 2009 Apr;16(2):141-9. doi: 10.1097/MED.0b013e3283293015.
PubMed 19262374
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
- ClinicalTrials.gov ID
- NCT00227110
- Acronym / sponsor ID
- UTHSCSA IRB# 001-5014-331
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- NASH, IGT, T2DM
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Takeda Pharmaceuticals North America, Inc.
- Study start
- Oct 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Jan 2006 (actual)
- First posted
- 27 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM).
Detailed description
- 4/1/2003 Role of Pioglitazone in the Treatment of Nonalcoholic Steatohepatitis
- PURPOSE/SPECIFIC AIMS To determine the role of pioglitazone in the treatment of nonalcoholic steatohepatitis (NASH) in patients with glucose intolerance or type 2 diabetes mellitus (T2DM). NASH is a disease characterized by elevated plasma aminotransferases and histopathological changes in liver characterized by hepatocellular steatosis, chronic inflammation and fibrosis (1-3). Pioglitazone, a new thiazolidinedione (TZD), has proven to be safe and effective for the treatment of type 2 diabetes mellitus (T2DM) (4). NASH affects ~10-20% of obese and type 2 diabetic subjects (1-3, 5, 6). While the pathogenesis of NASH is poorly understood, there is consensus that insulin resistance and its associated abnormalities in lipid metabolism play a key role in the development of liver fat accumulation, and TNF-alpha is a major mediator in the progression of liver damage (7-9). Currently, there is no satisfactory therapy for NASH.
Pioglitazone improves insulin sensitivity and glycemic control in patients with T2DM (4, 10-12), but the mechanism of action of TZDs is unclear (13, 14). Pioglitazone activates genes involved in lipid synthesis, causing a reduction in plasma free fatty acid (FFA) and triglycerides (15). TZDs decrease excessive triglyceride accumulation in liver (16), muscle (17), and visceral fat (11, 16, 18), with a redistribution of fat to subcutaneous adipose stores (14). TZDs also antagonize the metabolic effects of TNF-alpha (19-22). Because pioglitazone ameliorates insulin resistance, reverses the metabolic abnormalities that contribute to hepatic fat infiltration (increased plasma glucose, FFA, and triglyceride concentrations), and antagonizes the effects of TNF-alpha, it follows that pioglitazone may prove useful for the treatment of patients with NASH.
In order to evaluate this hypothesis, we plan to treat for 6 months a group of patients with impaired glucose tolerance (IGT) or T2DM with pioglitazone in a randomized, double-blinded, placebo-controlled trial. Three major endpoints will be measured before and after treatment (see Methods for a detailed description):
- Liver histologic response; assessed by liver biopsy. Steatosis and inflammatory changes will be quantified using a standardized staging system.
- Liver fat content: measured by liver magnetic resonance spectroscopy (MRS).
- Hepatic insulin sensitivity and glucose metabolism: Because fat infiltration of liver and muscle causes insulin resistance and impairs glucose tolerance, we will measure parameters of metabolic control including fasting plasma glucose, free fatty acids, fructosamine, HbA1c and fasting lipid profile. To assess the effect of pioglitazone on hepatic insulin sensitivity, fasting (basal) and postprandial hepatic glucose production will be studied using a double-tracer technique (infusion of 3-3H glucose combined with an oral glucose load radiolabeled with 1-14C glucose) (23). Glucose and lipid oxidation will be measured by indirect calorimetry (24). In addition, an index of hepatic and peripheral insulin sensitivity will be derived from the oral glucose tolerance test (OGTT) (25).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Active comparator | Drug: PioglitazonePioglitazone 30 mg/d will be given for 8 weeks and titrated to 45 mg/d until the end of the 6-month study in a randomized, double-blind, study design. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo once daily is given following a randomized, double-blind, placebo-controlled study design. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be able to communicate meaningfully with the Investigator and be legally competent to provide written informed consent.
- Patients must have an age range between 21 to 70 years (inclusive).
- NASH confirmed by liver biopsy.
- Subjects must meet the criteria for impaired glucose tolerance (FPG concentration <126 mg/dl and a two hour plasma glucose value during the oral glucose tolerance test [OGTT] ≥140 but <200 mg/dl) or type 2 diabetes mellitus (FPG concentration ≥ 126 mg/dl or a two hour plasma glucose value during the OGTT ≥200 mg/dl) (62). Subjects with a FPG greater than 260 mg/dl will be excluded from the study.
- Diabetic patients will be allowed to be on sulfonylureas or repaglinide but not on metformin, a thiazolidinedione or insulin. Patients must have been on a stable dose of allowed chronic medications for four weeks prior to entering the double-blind treatment period.
Key exclusion criteria (11 listed)
- Any cause of chronic liver disease other than NASH (such as -but not restricted to- alcohol or drug abuse, medication, chronic hepatitis B or C, autoimmune, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency).
- Any clinical evidence or history of ascitis, bleeding varices, or spontaneous encephalopathy.
- No past (for at least for 1 year) or current history of alcohol abuse (alcohol consumption greater than one drink per day).
- Prior surgical procedures to include gastroplasty, jejuno-ileal or jejunocolic bypass.
- Prior exposure to organic solvents such as carbon tetrachloride.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PioglitazoneAlso: Actos (Takeda Pharmaceuticals).30 mg/d for 8 weeks and titrated to 45 mg/d until completing 6 months of treatment. | Drug | Pioglitazone |
| PlaceboPlacebo is given to match pioglitazone. | Drug | Placebo |
Primary outcome
Liver histology (Kleiner criteria, Hepatology 2005)
Time frame: 6 months.
2 secondary outcomes
Liver fat content by MRS.
Time frame: 6 months.
Double-tracer OGTT (EGP, glucose clearance).
Time frame: 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
- Background: PubMed 19384246Cusi K. Thiazolidinediones in NASH. An odd couple meant to be? J Clin Gastroenterol. 2009 Jul;43(6):503-5. doi: 10.1097/MCG.0b013e3181a15e51. No abstract available.
- Results publication: PubMed 17135584Belfort R, Harrison SA, Brown K, Darland C, Finch J, Hardies J, Balas B, Gastaldelli A, Tio F, Pulcini J, Berria R, Ma JZ, Dwivedi S, Havranek R, Fincke C, DeFronzo R, Bannayan GA, Schenker S, Cusi K. A placebo-controlled trial of pioglitazone in subjects with nonalcoholic steatohepatitis. N Engl J Med. 2006 Nov 30;355(22):2297-307. doi: 10.1056/NEJMoa060326.
- Results publication: PubMed 17560678Balas B, Belfort R, Harrison SA, Darland C, Finch J, Schenker S, Gastaldelli A, Cusi K. Pioglitazone treatment increases whole body fat but not total body water in patients with non-alcoholic steatohepatitis. J Hepatol. 2007 Oct;47(4):565-70. doi: 10.1016/j.jhep.2007.04.013. Epub 2007 May 24.
- Results publication: PubMed 19670459Gastaldelli A, Harrison SA, Belfort-Aguilar R, Hardies LJ, Balas B, Schenker S, Cusi K. Importance of changes in adipose tissue insulin resistance to histological response during thiazolidinedione treatment of patients with nonalcoholic steatohepatitis. Hepatology. 2009 Oct;50(4):1087-93. doi: 10.1002/hep.23116.
- Results publication: PubMed 19353360Ali R, Cusi K. New diagnostic and treatment approaches in non-alcoholic fatty liver disease (NAFLD). Ann Med. 2009;41(4):265-78. doi: 10.1080/07853890802552437.
- Results publication: PubMed 19262374Cusi K. Nonalcoholic fatty liver disease in type 2 diabetes mellitus. Curr Opin Endocrinol Diabetes Obes. 2009 Apr;16(2):141-9. doi: 10.1097/MED.0b013e3283293015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Cusi, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pioglitazone in people with Nonalcoholic Steatohepatitis, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver histology (Kleiner criteria, Hepatology 2005) (time frame: 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00227110, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2009.