Fatty LiverPhase 4NCT01720719
Atorvastatin Versus Vitamin E in Treatment of Non-alcoholic Fatty Liver Disease
A Phase 4 study testing atorvastatin and Vitamin E in people with Fatty Liver and Dyslipidemias, run by Xin Gao at 1 site in China.
Trial summary
The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E 300mg qd therapy on liver fat content in patients with type 2 diabetes associated with high LDL-C and non-alcoholic fatty liver disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fatty Liver, Dyslipidemias, Diabetes Mellitus
- What is being tested?
- atorvastatin and Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- May 2013to Dec 2016
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign informed consent before involvement in any trial-related activity (trial-related activity refers to measures that will not be adopted during the normal treatment of patients).
- Male or female, 18 years ≤ age ≤ 70 years.
- Type 2 diabetes (already diagnosed or oral glucose tolerance test(OGTT) tested and found complying with the 2003 ADA diagnostic criteria for diabetes).
- Patients with non-alcoholic fatty liver disease, MRS measurement of liver fat content> 10%.
- Without taking any lipid-lowering drugs or Vitamin E in 3 months before enrollment.
- LDL-C ≥ 2.6mmol/L.
Show all 9Show fewer
- No heavy drinking history (alcohol intake: male < 20g/d, female < 10g/d).
- HBsAg (-), HCV-Ab (-).
- 18.5 kg/m2 ≤ BMI ≤ 40kg/m2
Who cannot join
- Liver, renal dysfunction (ALT or AST is 2.5 times higher than the upper limit of normal, or total bilirubin(TB) is 1.5 times higher than the upper limit of normal, or Cr ≥ 115μmol/L).
- Muscle enzyme is 2 times higher than normal.
- Type 1 diabetes, gestational diabetes, or other special types of diabetes.
- Has not used drugs that may affect the liver fat content, such as glucocorticoids and thyroxine within one month before and during the trial.
- With hypothyroidism, hypothalamic-pituitary dysfunction, sleep apnea syndrome, acanthosis nigricans, polycystic ovary syndrome, psoriasis, colorectal adenomas polyps and other diseases that NAFLD is easily associated with.
- Previous history of chronic viral hepatitis, autoimmune liver disease, drug-induced liver disease and other liver diseases caused by genetic factors.
Show all 11Show fewer
- Severe uncontrolled hypertension (treated, sitting resting systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100mmHg).
- Pregnancy, breastfeeding, planned pregnancy, or failure to take adequate contraceptive measures (contraception measures include sterilization, intrauterine device(IUD), oral contraceptives and consistent condom use).
- With intellectual, psychological or language barriers, so that the subjects cannot fully understand or cooperate with the study.
- Any circumstances that may affect the implementation or results of the study.
- Class III or Class IV heart disease by New York Heart Association(NYHA) classification, unstable angina or attack of myocardial infarction in recent 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xin Gao, doctor, 862164041990 ext. 8021, gao.xin@zs-hospital.sh.cn
Hongmei Yan, doctor, 13761666976, yan.hongmei@zs-hospital.sh.cn
About this study
Official title: An Randomized Open Label Trial on the Impact of 24 Weeks of Atorvastatin Therapy on Liver Fat Content and Abdominal Fat Content in Patients With Type 2 Diabetes Combined With High LDL-C and Non-alcoholic Fatty Liver Disease
The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E 300mg qd therapy on liver fat content in patients with type 2 diabetes associated with high LDL-C and non-alcoholic fatty liver disease.
Read the detailed description
Previous studies have preliminary proven the safety and efficacy of atorvastatin tablets in the treatment of Non-alcoholic fatty liver disease (NAFLD).However, the sample size of these studies is small and most studies use B-ultrasound or CT for semi-quantitative determination of liver fat content. The defects of evaluation methods seriously affect the accuracy of the studies. Also, antioxidant agents have been proposed as a potentially effective treatment. Vitamin E is a potent antioxidant compound, which has been tested in pediatric NAFLD because of the absence of side effects. Conflicting results have been reported in clinical trials, both in children and in adults. The project intends to adopt advanced proton magnetic resonance spectroscopy (1H-MRS) to non-invasively and precisely determine liver fat content and understand the change in liver fat content before and after the treatment with atorvastatin tablets or Vitamin E in NAFLD patients with abnormal lipid metabolism and type 2 diabetes. We also intend to compare the therapeutic effects of atorvastatin and Vitamin E in the treatment of NAFLD.
- Conditions
- Fatty Liver, Dyslipidemias, Diabetes Mellitus
- Being tested
- atorvastatin, Vitamin E
- Keywords
- Non-alcoholic Fatty Liver Disease, Dyslipidemias, Diabetes Mellitus, atorvastatin, Vitamin E
- Medical subject headings
- Fatty Liver, Dyslipidemias, Diabetes Mellitus, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Oral atorvastatin 20mg, qd, for 24 weeks
Vitamin EDrug
Oral Vitamin E 300mg, qd, for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E | Active comparator | Oral Vitamin E 300mg, qd, for 24 weeks Receives: Drug: Vitamin E |
| Atorvastatin | Experimental | Oral atorvastatin 20mg, qd, for 24 weeks Receives: Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver fat content(%)
MRS (magnetic resonance spectroscopy analysis): liver fat content (%).
Measured: 24 weeks
Secondary outcomes (8)
Abdominal visceral fat area(cm2)
MRI (magnetic resonance imaging): abdominal visceral fat area (cm2)
Measured: 24 weeks
Abdominal subcutaneous fat area(cm2)
MRI(Magnetic Resonance Imaging):abdominal subcutaneous fat content (cm2)
Measured: 24 weeks
Lipid profiles
lipid profiles (total cholesterol, HDL-C, LDL-C, very low density lipoprotein and free fatty acids)
Measured: 24 weeks
Liver enzymes
liver enzymes (Alanine aminotransferase(ALT), Aspartate aminotransferase(AST), Gamma-glutamyl transferase(GGT))
Measured: 24 weeks
Glucose metabolism
fasting plasma glucose(FPG), postprandial plasma glucose(PPG), HbA1c, fasting C-peptide and 2-hour postprandial C-peptide
Measured: 24 weeks
Body weight
Body weight
Measured: 24 weeks
Anthropometric test
waist and hip circumferences
Measured: 24 weeks
Muscle enzymes
MM isoenzyme of creatine kinase(CK-MM), MB isoenzyme of creatine kinase(CK-MB)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2012 (estimated)
- Study startMay 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xin Gao
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Xin Gao, Fudan University
- Investigators
- Xin Gao, doctor, Principal investigator, Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720719
- Sponsor's protocol ID
- WS2334187
- Status last verified
- Feb 2016
- First submitted
- 31 Oct 2012
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Angulo P. Nonalcoholic fatty liver disease. N Engl J Med. 2002 Apr 18;346(16):1221-31. doi: 10.1056/NEJMra011775. No abstract available.
PubMed 11961152Targher G, Bertolini L, Padovani R, Rodella S, Tessari R, Zenari L, Day C, Arcaro G. Prevalence of nonalcoholic fatty liver disease and its association with cardiovascular disease among type 2 diabetic patients. Diabetes Care. 2007 May;30(5):1212-8. doi: 10.2337/dc06-2247. Epub 2007 Feb 2.
PubMed 17277038Fan JG, Zhu J, Li XJ, Chen L, Lu YS, Li L, Dai F, Li F, Chen SY. Fatty liver and the metabolic syndrome among Shanghai adults. J Gastroenterol Hepatol. 2005 Dec;20(12):1825-32. doi: 10.1111/j.1440-1746.2005.04058.x.
PubMed 16336439Kotronen A, Yki-Jarvinen H. Fatty liver: a novel component of the metabolic syndrome. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):27-38. doi: 10.1161/ATVBAHA.107.147538. Epub 2007 Aug 9.
PubMed 17690317Ryysy L, Hakkinen AM, Goto T, Vehkavaara S, Westerbacka J, Halavaara J, Yki-Jarvinen H. Hepatic fat content and insulin action on free fatty acids and glucose metabolism rather than insulin absorption are associated with insulin requirements during insulin therapy in type 2 diabetic patients. Diabetes. 2000 May;49(5):749-58. doi: 10.2337/diabetes.49.5.749.
PubMed 10905483Seppala-Lindroos A, Vehkavaara S, Hakkinen AM, Goto T, Westerbacka J, Sovijarvi A, Halavaara J, Yki-Jarvinen H. Fat accumulation in the liver is associated with defects in insulin suppression of glucose production and serum free fatty acids independent of obesity in normal men. J Clin Endocrinol Metab. 2002 Jul;87(7):3023-8. doi: 10.1210/jcem.87.7.8638.
PubMed 12107194Adiels M, Taskinen MR, Packard C, Caslake MJ, Soro-Paavonen A, Westerbacka J, Vehkavaara S, Hakkinen A, Olofsson SO, Yki-Jarvinen H, Boren J. Overproduction of large VLDL particles is driven by increased liver fat content in man. Diabetologia. 2006 Apr;49(4):755-65. doi: 10.1007/s00125-005-0125-z. Epub 2006 Feb 4.
PubMed 16463046Malmstrom R, Packard CJ, Caslake M, Bedford D, Stewart P, Yki-Jarvinen H, Shepherd J, Taskinen MR. Defective regulation of triglyceride metabolism by insulin in the liver in NIDDM. Diabetologia. 1997 Apr;40(4):454-62. doi: 10.1007/s001250050700.
PubMed 9112023Hanley AJ, Williams K, Festa A, Wagenknecht LE, D'Agostino RB Jr, Kempf J, Zinman B, Haffner SM; insulin resistance atherosclerosis study. Elevations in markers of liver injury and risk of type 2 diabetes: the insulin resistance atherosclerosis study. Diabetes. 2004 Oct;53(10):2623-32. doi: 10.2337/diabetes.53.10.2623.
PubMed 15448093Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.
PubMed 16012941Mehta SR, Thomas EL, Patel N, Crofton ME, McCarthy J, Eliahoo J, Morin SX, Fitzpatrick J, Durighel G, Goldstone AP, Johnston DG, Bell JD, Taylor-Robinson SD. Proton magnetic resonance spectroscopy and ultrasound for hepatic fat quantification. Hepatol Res. 2010 Apr;40(4):399-406. doi: 10.1111/j.1872-034X.2009.00620.x. Epub 2010 Mar 4.
PubMed 20236356Argo CK, Loria P, Caldwell SH, Lonardo A. Statins in liver disease: a molehill, an iceberg, or neither? Hepatology. 2008 Aug;48(2):662-9. doi: 10.1002/hep.22402.
PubMed 18666246Hyogo H, Tazuma S, Arihiro K, Iwamoto K, Nabeshima Y, Inoue M, Ishitobi T, Nonaka M, Chayama K. Efficacy of atorvastatin for the treatment of nonalcoholic steatohepatitis with dyslipidemia. Metabolism. 2008 Dec;57(12):1711-8. doi: 10.1016/j.metabol.2008.07.030.
PubMed 19013295Kiyici M, Gulten M, Gurel S, Nak SG, Dolar E, Savci G, Adim SB, Yerci O, Memik F. Ursodeoxycholic acid and atorvastatin in the treatment of nonalcoholic steatohepatitis. Can J Gastroenterol. 2003 Dec;17(12):713-8. doi: 10.1155/2003/857869.
PubMed 14679419Rallidis LS, Drakoulis CK, Parasi AS. Pravastatin in patients with nonalcoholic steatohepatitis: results of a pilot study. Atherosclerosis. 2004 May;174(1):193-6. doi: 10.1016/j.atherosclerosis.2004.01.008. No abstract available.
PubMed 15135271
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Randomized Open Label Trial on the Impact of 24 Weeks of Atorvastatin Therapy on Liver Fat Content and Abdominal Fat Content in Patients With Type 2 Diabetes Combined With High LDL-C and Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT01720719
- Acronym / sponsor ID
- WS2334187
- Conditions
- Fatty Liver, Dyslipidemias, Diabetes Mellitus
- Keywords
- Non-alcoholic Fatty Liver Disease, Dyslipidemias, Diabetes Mellitus, atorvastatin, Vitamin E
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xin GaoUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Nov 2012 (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.
The purpose of the study is to compare the impact of atorvastatin 20mg qd and Vitamin E 300mg qd therapy on liver fat content in patients with type 2 diabetes associated with high LDL-C and non-alcoholic fatty liver disease.
Detailed description
Previous studies have preliminary proven the safety and efficacy of atorvastatin tablets in the treatment of Non-alcoholic fatty liver disease (NAFLD).However, the sample size of these studies is small and most studies use B-ultrasound or CT for semi-quantitative determination of liver fat content. The defects of evaluation methods seriously affect the accuracy of the studies. Also, antioxidant agents have been proposed as a potentially effective treatment. Vitamin E is a potent antioxidant compound, which has been tested in pediatric NAFLD because of the absence of side effects. Conflicting results have been reported in clinical trials, both in children and in adults. The project intends to adopt advanced proton magnetic resonance spectroscopy (1H-MRS) to non-invasively and precisely determine liver fat content and understand the change in liver fat content before and after the treatment with atorvastatin tablets or Vitamin E in NAFLD patients with abnormal lipid metabolism and type 2 diabetes. We also intend to compare the therapeutic effects of atorvastatin and Vitamin E in the treatment of NAFLD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E | Active comparator | Drug: Vitamin EOral Vitamin E 300mg, qd, for 24 weeks |
| Atorvastatin | Experimental | Drug: atorvastatinOral atorvastatin 20mg, qd, for 24 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Sign informed consent before involvement in any trial-related activity (trial-related activity refers to measures that will not be adopted during the normal treatment of patients).
- Male or female, 18 years ≤ age ≤ 70 years.
- Type 2 diabetes (already diagnosed or oral glucose tolerance test(OGTT) tested and found complying with the 2003 ADA diagnostic criteria for diabetes).
- Patients with non-alcoholic fatty liver disease, MRS measurement of liver fat content> 10%.
- Without taking any lipid-lowering drugs or Vitamin E in 3 months before enrollment.
Key exclusion criteria (11 listed)
- Liver, renal dysfunction (ALT or AST is 2.5 times higher than the upper limit of normal, or total bilirubin(TB) is 1.5 times higher than the upper limit of normal, or Cr ≥ 115μmol/L).
- Muscle enzyme is 2 times higher than normal.
- Type 1 diabetes, gestational diabetes, or other special types of diabetes.
- Has not used drugs that may affect the liver fat content, such as glucocorticoids and thyroxine within one month before and during the trial.
- With hypothyroidism, hypothalamic-pituitary dysfunction, sleep apnea syndrome, acanthosis nigricans, polycystic ovary syndrome, psoriasis, colorectal adenomas polyps and other diseases that NAFLD is easily associated with.
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 |
|---|---|---|
| atorvastatinOral atorvastatin 20mg, qd, for 24 weeks | Drug | Atorvastatin |
| Vitamin EOral Vitamin E 300mg, qd, for 24 weeks | Drug | Vitamin E |
Primary outcome
Liver fat content(%)
Time frame: 24 weeks
MRS (magnetic resonance spectroscopy analysis): liver fat content (%).
8 secondary outcomes
Abdominal visceral fat area(cm2)
Time frame: 24 weeks
Abdominal subcutaneous fat area(cm2)
Time frame: 24 weeks
Lipid profiles
Time frame: 24 weeks
Liver enzymes
Time frame: 24 weeks
Glucose metabolism
Time frame: 24 weeks
Body weight
Time frame: 24 weeks
Anthropometric test
Time frame: 24 weeks
Muscle enzymes
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Background: PubMed 11961152Angulo P. Nonalcoholic fatty liver disease. N Engl J Med. 2002 Apr 18;346(16):1221-31. doi: 10.1056/NEJMra011775. No abstract available.
- Background: PubMed 17277038Targher G, Bertolini L, Padovani R, Rodella S, Tessari R, Zenari L, Day C, Arcaro G. Prevalence of nonalcoholic fatty liver disease and its association with cardiovascular disease among type 2 diabetic patients. Diabetes Care. 2007 May;30(5):1212-8. doi: 10.2337/dc06-2247. Epub 2007 Feb 2.
- Background: PubMed 16336439Fan JG, Zhu J, Li XJ, Chen L, Lu YS, Li L, Dai F, Li F, Chen SY. Fatty liver and the metabolic syndrome among Shanghai adults. J Gastroenterol Hepatol. 2005 Dec;20(12):1825-32. doi: 10.1111/j.1440-1746.2005.04058.x.
- Background: PubMed 17690317Kotronen A, Yki-Jarvinen H. Fatty liver: a novel component of the metabolic syndrome. Arterioscler Thromb Vasc Biol. 2008 Jan;28(1):27-38. doi: 10.1161/ATVBAHA.107.147538. Epub 2007 Aug 9.
- Background: PubMed 10905483Ryysy L, Hakkinen AM, Goto T, Vehkavaara S, Westerbacka J, Halavaara J, Yki-Jarvinen H. Hepatic fat content and insulin action on free fatty acids and glucose metabolism rather than insulin absorption are associated with insulin requirements during insulin therapy in type 2 diabetic patients. Diabetes. 2000 May;49(5):749-58. doi: 10.2337/diabetes.49.5.749.
- Background: PubMed 12107194Seppala-Lindroos A, Vehkavaara S, Hakkinen AM, Goto T, Westerbacka J, Sovijarvi A, Halavaara J, Yki-Jarvinen H. Fat accumulation in the liver is associated with defects in insulin suppression of glucose production and serum free fatty acids independent of obesity in normal men. J Clin Endocrinol Metab. 2002 Jul;87(7):3023-8. doi: 10.1210/jcem.87.7.8638.
- Background: PubMed 16463046Adiels M, Taskinen MR, Packard C, Caslake MJ, Soro-Paavonen A, Westerbacka J, Vehkavaara S, Hakkinen A, Olofsson SO, Yki-Jarvinen H, Boren J. Overproduction of large VLDL particles is driven by increased liver fat content in man. Diabetologia. 2006 Apr;49(4):755-65. doi: 10.1007/s00125-005-0125-z. Epub 2006 Feb 4.
- Background: PubMed 9112023Malmstrom R, Packard CJ, Caslake M, Bedford D, Stewart P, Yki-Jarvinen H, Shepherd J, Taskinen MR. Defective regulation of triglyceride metabolism by insulin in the liver in NIDDM. Diabetologia. 1997 Apr;40(4):454-62. doi: 10.1007/s001250050700.
- Background: PubMed 15448093Hanley AJ, Williams K, Festa A, Wagenknecht LE, D'Agostino RB Jr, Kempf J, Zinman B, Haffner SM; insulin resistance atherosclerosis study. Elevations in markers of liver injury and risk of type 2 diabetes: the insulin resistance atherosclerosis study. Diabetes. 2004 Oct;53(10):2623-32. doi: 10.2337/diabetes.53.10.2623.
- Background: PubMed 16012941Adams LA, Lymp JF, St Sauver J, Sanderson SO, Lindor KD, Feldstein A, Angulo P. The natural history of nonalcoholic fatty liver disease: a population-based cohort study. Gastroenterology. 2005 Jul;129(1):113-21. doi: 10.1053/j.gastro.2005.04.014.
- Background: PubMed 20236356Mehta SR, Thomas EL, Patel N, Crofton ME, McCarthy J, Eliahoo J, Morin SX, Fitzpatrick J, Durighel G, Goldstone AP, Johnston DG, Bell JD, Taylor-Robinson SD. Proton magnetic resonance spectroscopy and ultrasound for hepatic fat quantification. Hepatol Res. 2010 Apr;40(4):399-406. doi: 10.1111/j.1872-034X.2009.00620.x. Epub 2010 Mar 4.
- Background: PubMed 18666246Argo CK, Loria P, Caldwell SH, Lonardo A. Statins in liver disease: a molehill, an iceberg, or neither? Hepatology. 2008 Aug;48(2):662-9. doi: 10.1002/hep.22402.
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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.
Xin Gao, doctor principal investigator
Department of Endocrinology and Metabolism, Zhongshan Hospital, Fudan University
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 atorvastatin and Vitamin E in people with Fatty Liver and Dyslipidemias, run by Xin Gao at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 3 Feb 2016. 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 China. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Gao, doctor (862164041990 ext. 8021, gao.xin@zs-hospital.sh.cn; happy20061208@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver fat content(%) (time frame: 24 weeks). 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 NCT01720719, which also lists 37 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 3 Feb 2016.