Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-02-19
2022-03-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bariatric Surgery
Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to either laparoscopic Roux-en-Y Gastric Bypass or laparoscopic Sleeve Gastrectomy
Bariatric Surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
Lifestyle Modification
Obese patients, BMI from 30 to 45, with or without type 2 diabetes, submitted to guided diet and physical activity.
Lifestyle modification
guided low-calorie diet and physical activity.
Interventions
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Bariatric Surgery
laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
Lifestyle modification
guided low-calorie diet and physical activity.
Eligibility Criteria
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Inclusion Criteria
* with biopsy-proven NASH
* with or without type 2 diabetes
* that fit for bariatric surgery.
Exclusion Criteria
* alcohol consumption (\> 20 g/day for men and \> 10 g/day for women, for the last 2 years);
* other hepatic diseases (such as viral hepatitis, autoimmune hepatitis, drug-induced hepatic disease, Wilson's disease, hemochromatosis);
* HIV infection;
* unable to provide informed consent;
* previous foregut or bariatric surgery;
* malignancy;
* patients that unfit for bariatric surgery.
18 Years
65 Years
ALL
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Responsible Party
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Principal Investigators
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Guilherme S Mazzini, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital de Clínicas de Porto Alegre
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-0780
Identifier Type: -
Identifier Source: org_study_id
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