Non-Alcoholic Fatty Liver DiseaseNASH-APOLLONCT03426111
Multicenter, Randomized, Controlled and Double-blind Study of Efficacy and Safety of Endoscopic Gastric Tubulization in Patients With Non-alcoholic Steatohepatitis (NASH-APOLLO).
A study testing Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) and Lifestyle modification in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Puerta de Hierro University Hospital at 1 site in Spain.
Trial summary
Nonalcoholic steatohepatitis is a growing public health problem affecting over 5% of the population. These patients are at increased risk of cardiovascular and liver-related death and have higher rates of malignancy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) and Lifestyle modification
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 18 Apr 2018to Dec 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged between 18 and 75 years (inclusive) at the time of the first screening visit.
- They must provide signed written informed consent and agree to comply the study protocol
- Body mass index> 30 kg / m².
- Histological confirmation of steatohepatitis in a diagnostic liver biopsy (biopsy obtained in the 6 months prior to randomization or during the selection period) with at least a score of 1 in each component of the NAS score (steatosis with a score of 0 to 3, degeneration by ballooning with a score of 0 to 2 and lobular inflammation with a score of 0 to 3) and fibrosis of 0 to <4, according to the staging system of CRN fibrosis on NASH.
- NAS score ≥ 4.
- For patients without fibrosis or with stage 1 fibrosis, the NAS score≥5 and one of the following conditions (metabolic syndrome (definition NCEP ATP III), DM type II, HOMA-IR> 6).
- The liver biopsy should have been done with a 16 G trucut needle and the minimum size should be 25 mm.
Who cannot join
- Known heart failure (Grade I to IV of the classification of the New York Heart Association).
- History of effective bariatric surgery in the 5 years prior to selection.
- Patients with a history of clinically significant acute cardiac event in the 6 months prior to selection, such as: acute cardiovascular event, cerebrovascular accident, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- Weight loss of more than 5% in the 6 months prior to randomization.
- Liver cirrhosis.
- Non-cirrhotic portal hypertension.
Show all 23Show fewer
- Recent or current background of significant consumption of alcoholic beverages (<5 years). In the case of men, significant consumption is usually defined as more than 30 g of pure alcohol per day. In the case of women, it is usually defined as more than 20 g of pure alcohol per day.
- Esophagogastric varices.
- Hepatocellular carcinoma
- Portal thrombosis.
- Pregnancy.
- Refusal to give informed consent.
- Any medical condition that could reduce life expectancy to less than 2 years, including known cancers.
- Signs of any other unstable or clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric disease without treatment.
- Instability or mental incompetence, so that the validity of the informed consent or the ability to comply with the study are uncertain.
- In addition to the above criteria, the patient must not present any of the following biological exclusion criteria:
- Antibodies positive for the human immunodeficiency virus.
- Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (ULN).
- Total bilirubin> 25 μmol / l (1.5 mg / dl).
- Standardized international index> 1.4.
- Platelet count <100 000 / mm3.
- Serum creatinine levels> 135 μmol / l (> 1.53 mg / dl) in men and> 110 μmol / l (> 1.24 mg / dl) in women.
- Significant renal disease, including nephritic syndrome, chronic kidney disease (patients with markers of hepatic injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the eGFR measurement may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the expected randomization. An abnormal repeated eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Jose Luis Calleja
Majadahonda, Madrid, 28222
Jose Luis Calleja, Prof, +34911916000 ext. 417175, joseluis.calleja@uam.es
Javier Abad, MD, +34650814289, jabad@salud.madrid.org
About this study
Nonalcoholic steatohepatitis is a growing public health problem affecting over 5% of the population. These patients are at increased risk of cardiovascular and liver-related death and have higher rates of malignancy.
The currently standard of care is weight loss and physical exercise, with histological and analytical improvement in patients achieving a 5-10% reduction in body weight. However, less than 25% of the subjects achieve this goal. In obese patients , restrictive surgical treatments and gastric bypass have been successful in improving the metabolic syndrome, insulin resistance and liver histology.
Currently, less invasive and less costly endoscopic techniques are being developed. These techniques also achieve a gastric restriction with similar results than bariatric surgery. One of these is the OverStitch® system (Apollo Endosurgery, Austin, TX, USA). Our aim is to evaluate the efficacy and safety of this method in the improvement of liver histology in obese patients with nonalcoholic steatohepatitis.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Being tested
- Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA), Lifestyle modification
- Keywords
- Non-Alcoholic Fatty Liver Disease, NASH, Obesity, Endoscopic gastric tubulization, Non-alcoholic steatohepatitis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA)Device
This endoscopic technique is defined as a gastric restriction by means of sutures of the entire gastric wall, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan).
Lifestyle modificationBehavioural
Hypocaloric diet and moderate physical exercise
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Diagnostic upper endoscopy plus lifestyle modification. Receives: Behavioral: Lifestyle modification |
| Treatment | Active comparator | Endoscopic gastric tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) plus lifestyle modification. Receives: Device: Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA); Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of gastric tubulization + modification in lifestyle for 72 weeks compared to standard treatment / placebo in the resolution of NASH without worsening of fibrosis.
NASH resolution is defined as the disappearance of ballooning and the disappearance or persistence of minimal lobular inflammation (grade 0 or 1) The worsening of fibrosis is defined as the progression of at least one stage.
Measured: 72 weeks
Secondary outcomes (12)
Number of patients with improvement of fibrosis according to the CRN score NASH.
to evaluate other histological changes after 72 weeks of treatment (CRN)
Measured: 72 weeks
Non alcoholic fatty liver disease (NASH) activity score (NAS).
Number of patients with improvement in histological scores CRN score on NASH (NAS)
Measured: 72 weeks
steatosis-activity-fibrosis index score (steatosis activity fibrosis, SAF).
Number of patients with improvement in the SAF score.
Measured: 72 weeks
Cardiovascular and death events related to the liver
To evaluate the CV events in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Changes in liver enzymes
To evaluate liver enzymes in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Changes in the noninvasive markers of fibrosis and steatosis
To evaluate the noninvasive markers in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Changes in lipid parameters
To evaluate the lipid parameters in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Variation in body weight
To evaluate body weight in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Biomarkers of endothelial and macrophage dysfunction
To evaluate macrophage function in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Changes in markers of homeostasis of glucose and insulin resistance
To evaluate the glucose metabolism in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Changes in cardiovascular risk profile
To evaluate cardiovascular risk profile in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Changes in quality of life (abbreviated health questionnaire SF-36).
To evaluate the following endpoints in patients treated with gastric endoscopic tubulization + lifestyle modification with respect to lifestyle modification / placebo
Measured: 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start18 Apr 2018
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized,controlled and double-blind study with two parallel arms, placebo (normal endoscopy and lifestyle modification) or endoscopic gastric tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) and lifestyle modification.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Puerta de Hierro University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal, Hospital Universitario Marqués de Valdecilla, Hospitales Universitarios Virgen del Rocío
- Responsible party
- Principal investigator, Jose Luis Calleja, Puerta de Hierro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426111
- Sponsor's protocol ID
- PI17-00499
- Acronym
- NASH-APOLLO
- Status last verified
- Dec 2018
- First submitted
- 9 Jan 2018
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
PubMed 26707365Wanless IR, Lentz JS. Fatty liver hepatitis (steatohepatitis) and obesity: an autopsy study with analysis of risk factors. Hepatology. 1990 Nov;12(5):1106-10. doi: 10.1002/hep.1840120505.
PubMed 2227807Stepanova M, Rafiq N, Makhlouf H, Agrawal R, Kaur I, Younoszai Z, McCullough A, Goodman Z, Younossi ZM. Predictors of all-cause mortality and liver-related mortality in patients with non-alcoholic fatty liver disease (NAFLD). Dig Dis Sci. 2013 Oct;58(10):3017-23. doi: 10.1007/s10620-013-2743-5. Epub 2013 Jun 18.
PubMed 23775317Michelotti GA, Machado MV, Diehl AM. NAFLD, NASH and liver cancer. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):656-65. doi: 10.1038/nrgastro.2013.183. Epub 2013 Oct 1.
PubMed 24080776Adams LA, Sanderson S, Lindor KD, Angulo P. The histological course of nonalcoholic fatty liver disease: a longitudinal study of 103 patients with sequential liver biopsies. J Hepatol. 2005 Jan;42(1):132-8. doi: 10.1016/j.jhep.2004.09.012.
PubMed 15629518Angulo P. Diagnosing steatohepatitis and predicting liver-related mortality in patients with NAFLD: two distinct concepts. Hepatology. 2011 Jun;53(6):1792-4. doi: 10.1002/hep.24403. No abstract available.
PubMed 21557278Neuschwander-Tetri BA. Non-alcoholic fatty liver disease. BMC Med. 2017 Feb 28;15(1):45. doi: 10.1186/s12916-017-0806-8.
PubMed 28241825Gallego-Duran R, Cerro-Salido P, Gomez-Gonzalez E, Pareja MJ, Ampuero J, Rico MC, Aznar R, Vilar-Gomez E, Bugianesi E, Crespo J, Gonzalez-Sanchez FJ, Aparcero R, Moreno I, Soto S, Arias-Loste MT, Abad J, Ranchal I, Andrade RJ, Calleja JL, Pastrana M, Iacono OL, Romero-Gomez M. Imaging biomarkers for steatohepatitis and fibrosis detection in non-alcoholic fatty liver disease. Sci Rep. 2016 Aug 12;6:31421. doi: 10.1038/srep31421.
PubMed 27514671Barr J, Caballeria J, Martinez-Arranz I, Dominguez-Diez A, Alonso C, Muntane J, Perez-Cormenzana M, Garcia-Monzon C, Mayo R, Martin-Duce A, Romero-Gomez M, Lo Iacono O, Tordjman J, Andrade RJ, Perez-Carreras M, Le Marchand-Brustel Y, Tran A, Fernandez-Escalante C, Arevalo E, Garcia-Unzueta M, Clement K, Crespo J, Gual P, Gomez-Fleitas M, Martinez-Chantar ML, Castro A, Lu SC, Vazquez-Chantada M, Mato JM. Obesity-dependent metabolic signatures associated with nonalcoholic fatty liver disease progression. J Proteome Res. 2012 Apr 6;11(4):2521-32. doi: 10.1021/pr201223p. Epub 2012 Mar 15.
PubMed 22364559Alkhouri N, Feldstein AE. Noninvasive diagnosis of nonalcoholic fatty liver disease: Are we there yet? Metabolism. 2016 Aug;65(8):1087-95. doi: 10.1016/j.metabol.2016.01.013. Epub 2016 Feb 2.
PubMed 26972222Nobili V, Parkes J, Bottazzo G, Marcellini M, Cross R, Newman D, Vizzutti F, Pinzani M, Rosenberg WM. Performance of ELF serum markers in predicting fibrosis stage in pediatric non-alcoholic fatty liver disease. Gastroenterology. 2009 Jan;136(1):160-7. doi: 10.1053/j.gastro.2008.09.013. Epub 2008 Sep 20.
PubMed 18992746Ratziu V, Massard J, Charlotte F, Messous D, Imbert-Bismut F, Bonyhay L, Tahiri M, Munteanu M, Thabut D, Cadranel JF, Le Bail B, de Ledinghen V, Poynard T; LIDO Study Group; CYTOL study group. Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2006 Feb 14;6:6. doi: 10.1186/1471-230X-6-6.
PubMed 16503961Vilar-Gomez E, Martinez-Perez Y, Calzadilla-Bertot L, Torres-Gonzalez A, Gra-Oramas B, Gonzalez-Fabian L, Friedman SL, Diago M, Romero-Gomez M. Weight Loss Through Lifestyle Modification Significantly Reduces Features of Nonalcoholic Steatohepatitis. Gastroenterology. 2015 Aug;149(2):367-78.e5; quiz e14-5. doi: 10.1053/j.gastro.2015.04.005. Epub 2015 Apr 10.
PubMed 25865049Klebanoff MJ, Corey KE, Chhatwal J, Kaplan LM, Chung RT, Hur C. Bariatric surgery for nonalcoholic steatohepatitis: A clinical and cost-effectiveness analysis. Hepatology. 2017 Apr;65(4):1156-1164. doi: 10.1002/hep.28958. Epub 2017 Feb 21.
PubMed 27880977Mummadi RR, Kasturi KS, Chennareddygari S, Sood GK. Effect of bariatric surgery on nonalcoholic fatty liver disease: systematic review and meta-analysis. Clin Gastroenterol Hepatol. 2008 Dec;6(12):1396-402. doi: 10.1016/j.cgh.2008.08.012. Epub 2008 Aug 19.
PubMed 18986848
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Controlled and Double-blind Study of Efficacy and Safety of Endoscopic Gastric Tubulization in Patients With Non-alcoholic Steatohepatitis (NASH-APOLLO).
- ClinicalTrials.gov ID
- NCT03426111
- Acronym / sponsor ID
- NASH-APOLLO / PI17-00499
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Keywords
- Non-Alcoholic Fatty Liver Disease, NASH, Obesity, Endoscopic gastric tubulization, Non-alcoholic steatohepatitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Puerta de Hierro University HospitalUniversity, hospital or other
- Collaborators
- Hospital Universitario Ramon y Cajal, Hospital Universitario Marqués de Valdecilla, Hospitales Universitarios Virgen del Rocío
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 8 Feb 2018 (actual)
- 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.
Nonalcoholic steatohepatitis is a growing public health problem affecting over 5% of the population. These patients are at increased risk of cardiovascular and liver-related death and have higher rates of malignancy.
The currently standard of care is weight loss and physical exercise, with histological and analytical improvement in patients achieving a 5-10% reduction in body weight. However, less than 25% of the subjects achieve this goal. In obese patients , restrictive surgical treatments and gastric bypass have been successful in improving the metabolic syndrome, insulin resistance and liver histology.
Currently, less invasive and less costly endoscopic techniques are being developed. These techniques also achieve a gastric restriction with similar results than bariatric surgery. One of these is the OverStitch® system (Apollo Endosurgery, Austin, TX, USA). Our aim is to evaluate the efficacy and safety of this method in the improvement of liver histology in obese patients with nonalcoholic steatohepatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Multicenter, randomized,controlled and double-blind study with two parallel arms, placebo (normal endoscopy and lifestyle modification) or endoscopic gastric tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) and lifestyle modification.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: Lifestyle modificationDiagnostic upper endoscopy plus lifestyle modification. |
| Treatment | Active comparator | Device: Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA), Behavioral: Lifestyle modificationEndoscopic gastric tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) plus lifestyle modification. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men or women aged between 18 and 75 years (inclusive) at the time of the first screening visit.
- They must provide signed written informed consent and agree to comply the study protocol
- Body mass index> 30 kg / m².
- Histological confirmation of steatohepatitis in a diagnostic liver biopsy (biopsy obtained in the 6 months prior to randomization or during the selection period) with at least a score of 1 in each component of the NAS score (steatosis with a score of 0 to 3, degeneration by ballooning with a score of 0 to 2 and lobular inflammation with a score of 0 to 3) and fibrosis of 0 to <4, according to the staging system of CRN fibrosis on NASH.
- NAS score ≥ 4.
Key exclusion criteria (23 listed)
- Known heart failure (Grade I to IV of the classification of the New York Heart Association).
- History of effective bariatric surgery in the 5 years prior to selection.
- Patients with a history of clinically significant acute cardiac event in the 6 months prior to selection, such as: acute cardiovascular event, cerebrovascular accident, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
- Weight loss of more than 5% in the 6 months prior to randomization.
- Liver cirrhosis.
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 |
|---|---|---|
| Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA)This endoscopic technique is defined as a gastric restriction by means of sutures of the entire gastric wall, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan). | Device | Treatment |
| Lifestyle modificationHypocaloric diet and moderate physical exercise | Behavioural | Placebo, Treatment |
Primary outcome
To evaluate the efficacy of gastric tubulization + modification in lifestyle for 72 weeks compared to standard treatment / placebo in the resolution of NASH without worsening of fibrosis.
Time frame: 72 weeks
NASH resolution is defined as the disappearance of ballooning and the disappearance or persistence of minimal lobular inflammation (grade 0 or 1) The worsening of fibrosis is defined as the progression of at least one stage.
12 secondary outcomes
Number of patients with improvement of fibrosis according to the CRN score NASH.
Time frame: 72 weeks
Non alcoholic fatty liver disease (NASH) activity score (NAS).
Time frame: 72 weeks
steatosis-activity-fibrosis index score (steatosis activity fibrosis, SAF).
Time frame: 72 weeks
Cardiovascular and death events related to the liver
Time frame: 72 weeks
Changes in liver enzymes
Time frame: 72 weeks
Changes in the noninvasive markers of fibrosis and steatosis
Time frame: 72 weeks
Changes in lipid parameters
Time frame: 72 weeks
Variation in body weight
Time frame: 72 weeks
Biomarkers of endothelial and macrophage dysfunction
Time frame: 72 weeks
Changes in markers of homeostasis of glucose and insulin resistance
Time frame: 72 weeks
Changes in cardiovascular risk profile
Time frame: 72 weeks
Changes in quality of life (abbreviated health questionnaire SF-36).
Time frame: 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2018.
- Background: PubMed 26707365Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.
- Background: PubMed 2227807Wanless IR, Lentz JS. Fatty liver hepatitis (steatohepatitis) and obesity: an autopsy study with analysis of risk factors. Hepatology. 1990 Nov;12(5):1106-10. doi: 10.1002/hep.1840120505.
- Background: PubMed 23775317Stepanova M, Rafiq N, Makhlouf H, Agrawal R, Kaur I, Younoszai Z, McCullough A, Goodman Z, Younossi ZM. Predictors of all-cause mortality and liver-related mortality in patients with non-alcoholic fatty liver disease (NAFLD). Dig Dis Sci. 2013 Oct;58(10):3017-23. doi: 10.1007/s10620-013-2743-5. Epub 2013 Jun 18.
- Background: PubMed 24080776Michelotti GA, Machado MV, Diehl AM. NAFLD, NASH and liver cancer. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):656-65. doi: 10.1038/nrgastro.2013.183. Epub 2013 Oct 1.
- Background: PubMed 15629518Adams LA, Sanderson S, Lindor KD, Angulo P. The histological course of nonalcoholic fatty liver disease: a longitudinal study of 103 patients with sequential liver biopsies. J Hepatol. 2005 Jan;42(1):132-8. doi: 10.1016/j.jhep.2004.09.012.
- Background: PubMed 21557278Angulo P. Diagnosing steatohepatitis and predicting liver-related mortality in patients with NAFLD: two distinct concepts. Hepatology. 2011 Jun;53(6):1792-4. doi: 10.1002/hep.24403. No abstract available.
- Background: PubMed 28241825Neuschwander-Tetri BA. Non-alcoholic fatty liver disease. BMC Med. 2017 Feb 28;15(1):45. doi: 10.1186/s12916-017-0806-8.
- Background: PubMed 27514671Gallego-Duran R, Cerro-Salido P, Gomez-Gonzalez E, Pareja MJ, Ampuero J, Rico MC, Aznar R, Vilar-Gomez E, Bugianesi E, Crespo J, Gonzalez-Sanchez FJ, Aparcero R, Moreno I, Soto S, Arias-Loste MT, Abad J, Ranchal I, Andrade RJ, Calleja JL, Pastrana M, Iacono OL, Romero-Gomez M. Imaging biomarkers for steatohepatitis and fibrosis detection in non-alcoholic fatty liver disease. Sci Rep. 2016 Aug 12;6:31421. doi: 10.1038/srep31421.
- Background: PubMed 22364559Barr J, Caballeria J, Martinez-Arranz I, Dominguez-Diez A, Alonso C, Muntane J, Perez-Cormenzana M, Garcia-Monzon C, Mayo R, Martin-Duce A, Romero-Gomez M, Lo Iacono O, Tordjman J, Andrade RJ, Perez-Carreras M, Le Marchand-Brustel Y, Tran A, Fernandez-Escalante C, Arevalo E, Garcia-Unzueta M, Clement K, Crespo J, Gual P, Gomez-Fleitas M, Martinez-Chantar ML, Castro A, Lu SC, Vazquez-Chantada M, Mato JM. Obesity-dependent metabolic signatures associated with nonalcoholic fatty liver disease progression. J Proteome Res. 2012 Apr 6;11(4):2521-32. doi: 10.1021/pr201223p. Epub 2012 Mar 15.
- Background: PubMed 26972222Alkhouri N, Feldstein AE. Noninvasive diagnosis of nonalcoholic fatty liver disease: Are we there yet? Metabolism. 2016 Aug;65(8):1087-95. doi: 10.1016/j.metabol.2016.01.013. Epub 2016 Feb 2.
- Background: PubMed 18992746Nobili V, Parkes J, Bottazzo G, Marcellini M, Cross R, Newman D, Vizzutti F, Pinzani M, Rosenberg WM. Performance of ELF serum markers in predicting fibrosis stage in pediatric non-alcoholic fatty liver disease. Gastroenterology. 2009 Jan;136(1):160-7. doi: 10.1053/j.gastro.2008.09.013. Epub 2008 Sep 20.
- Background: PubMed 16503961Ratziu V, Massard J, Charlotte F, Messous D, Imbert-Bismut F, Bonyhay L, Tahiri M, Munteanu M, Thabut D, Cadranel JF, Le Bail B, de Ledinghen V, Poynard T; LIDO Study Group; CYTOL study group. Diagnostic value of biochemical markers (FibroTest-FibroSURE) for the prediction of liver fibrosis in patients with non-alcoholic fatty liver disease. BMC Gastroenterol. 2006 Feb 14;6:6. doi: 10.1186/1471-230X-6-6.
- Individual participant dataSharing planned: Undecided
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NAFLD (Nonalcoholic Fatty Liver Disease)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA) and Lifestyle modification in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by Puerta de Hierro University Hospital at 1 site in Spain.
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 7 inclusion and 23 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 12 Dec 2018. 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 Spain. 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.
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 Jose Luis Calleja, Prof (+34911916000 ext. 417175, joseluis.calleja@uam.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of gastric tubulization + modification in lifestyle for 72 weeks compared to standard treatment / placebo in the resolution of NASH without worsening of fibrosis. (time frame: 72 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 NCT03426111, which also lists 18 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 12 Dec 2018.