Obesity Clinical Trial
Official title:
Effects of Bariatric Surgery on Non-Alcoholic Steatohepatitis
NCT number | NCT04043585 |
Other study ID # | EBSoNAS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 31, 2019 |
Est. completion date | March 29, 2023 |
Verified date | November 2023 |
Source | University Hospital, Gentofte, Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study investigates non-alcoholic fatty liver disease from serial liver biopsies collected from participants referred for assessment of bariatric surgery, RYGB or SG.
Status | Completed |
Enrollment | 29 |
Est. completion date | March 29, 2023 |
Est. primary completion date | March 29, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Obese (BMI=35 kg/m2) individuals referred for bariatric surgery, either RYGB or SG - Age between 18 and 60 years at the time of inclusion - Evidence of potential NASH with fibrosis - Willing to give informed consent and comply with all study procedures Exclusion Criteria: - Type 1 diabetes - Alcohol consumption =20 g/day for women or =30 g/day for men over a two-year period prior to inclusion - Clinically significant kidney function impairment or other laboratory findings at time of screening leading to the diagnosis of clinically relevant disorders - Any physical or psychological condition that the investigator evaluates would interfere with trial participation - Previous gastrointestinal surgery (excluding cholecystectomy and appendectomy) - Planned elective surgery (other than bariatric surgery) during the study period with the exception of dermatosurgical, ENT (ear, nose, throat) or dental procedures not requiring general anaesthesia and/or perioperative antibiotic treatment - Pregnancy or desire to become pregnant during the study period - Any ongoing medication that the investigator evaluates would interfere with trial participation including anticoagulant medication, and medication that could cause NAFLD - Contraindications to liver biopsy - Other causes of liver disease than NAFLD, including viral hepatitis, Wilsons disease, cystic fibrosis, coeliac disease and alpha-1 antitrypsin deficiency. |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Clinical Metabolic Research | Hellerup |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Gentofte, Copenhagen | Gubra ApS |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NAFLD activity score | Change in NAFLD activity score (NAS). Assessment of NAS, a standardized tool for assessment of liver histology, is often used for quantification of disease activity, allowing comparison of biopsies in clinical studies and improved reproducibility. The NAS is defined as the sum of scores for steatosis (0-3), lobular inflammation (0-3) and ballooning degeneration (0-2) | 18 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04101669 -
EndoBarrier System Pivotal Trial(Rev E v2)
|
N/A | |
Recruiting |
NCT04243317 -
Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults
|
N/A | |
Terminated |
NCT03772886 -
Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball
|
N/A | |
Completed |
NCT03640442 -
Modified Ramped Position for Intubation of Obese Females.
|
N/A | |
Completed |
NCT04506996 -
Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2
|
N/A | |
Recruiting |
NCT06019832 -
Analysis of Stem and Non-Stem Tibial Component
|
N/A | |
Active, not recruiting |
NCT05891834 -
Study of INV-202 in Patients With Obesity and Metabolic Syndrome
|
Phase 2 | |
Active, not recruiting |
NCT05275959 -
Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)
|
N/A | |
Recruiting |
NCT04575194 -
Study of the Cardiometabolic Effects of Obesity Pharmacotherapy
|
Phase 4 | |
Completed |
NCT04513769 -
Nutritious Eating With Soul at Rare Variety Cafe
|
N/A | |
Withdrawn |
NCT03042897 -
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer
|
N/A | |
Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
Recruiting |
NCT05917873 -
Metabolic Effects of Four-week Lactate-ketone Ester Supplementation
|
N/A | |
Active, not recruiting |
NCT04353258 -
Research Intervention to Support Healthy Eating and Exercise
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Recruiting |
NCT03227575 -
Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control
|
N/A | |
Completed |
NCT01870947 -
Assisted Exercise in Obese Endometrial Cancer Patients
|
N/A | |
Recruiting |
NCT06007404 -
Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
|
||
Recruiting |
NCT05972564 -
The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function
|
Phase 1/Phase 2 | |
Recruiting |
NCT05371496 -
Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction
|
Phase 2 |