Additive effect of Roux-en Y Gastric Bypass to preoperative Very low calorie diet on non-alcoholic fatty liver diseases (NAFLD, NASH) - A randomized controlled trial
Organizational Data
- DRKS-ID:
- DRKS00027810
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2022-03-03
- Last update in DRKS:
- 2023-02-08
- Registration type:
- Prospective
Acronym/abbreviation of the study
NASH IN RYGB
URL of the study
No Entry
Brief summary in lay language
This trial aims to investigate, whether not only there is a positive effect of either very low calorie diet (VLCD) or Roux-en-Y Gastric Bypass (RYGB) on non-alcoholic fatty liver disease (NAFLD) in morbidly obese patients, but also if there might be an additive effect if both therapies are combined. For this, we will be obtaining liver biopsies from patients receiving VLCD or VLCD and RYGB.
Brief summary in scientific language
Objectives: To investigate the additive short-term effect of Roux-en-Y gastric bypass (RYGB) in addition to verly-low calorie diet vs. only standardized very-low calorie diet in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) For this purpose, tow patient groups will be compared to each other. Both groups will receive two liver biopsies during different points in time. Both groups will receive VLCD 2 weeks prior to surgery and two weeks after surgery. All Patients will receive RYGB. The first group will receive a biopsy before VLCD and surgery and during surgery. The second group will receive one biopsy during surgery and one after surgery and an additional 2 weeks of vlcd.
Health condition or problem studied
- ICD10:
- K75.8 - Other specified inflammatory liver diseases
- ICD10:
- E66.0 - Obesity due to excess calories
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- This Arm will receive two liver biopsies. The patients will receive RYGB on grounds of morbid obesity as recommended via guidelines. Prior to surgery and two weeks after surgery, the patient swill receive a VLCD of maximum 800-900cKal/day of liquid diet for two weeks. This will be continues for 2 Weeks after surgery. The first biopsy will be ultrasound-guided 2 weeks prior to surgery, the second biopsy will be performed intraoperatively after two weeks of VLCD. Blood will be drawn at both points in time, we will also measure BMI and obtain a bioimpedance analysis.
- Arm 2:
- This Arm will receive two liver biopsies. The patients will receive RYGB on grounds of morbid obesity as recommended via guidelines. Prior to surgery and two weeks after surgery, the patient swill receive a VLCD of maximum 800-900cKal/day of liquid diet for two weeks. This will be continues for 2 Weeks after surgery. The first biopsy will be performed during surgery, the second biopsy will be performed percutaneously two weeks after surgery and VLCD. Blood will be drawn at both points in time, we will also measure BMI and obtain a bioimpedance analysis.
Endpoints
- Primary outcome:
- Change in NASH activity score (NAS)
- Secondary outcome:
- - laboratory parameters (small blood count, AP, gamma-GT, Bilirubin, ALT, AST, Albumin, PT, Choline esterase, blood sugar, HbA1c) - change in NAS components ~ steatosis ~ lobular inflammation ~ hepatocyte ballooning - change in fibrosis - change in estimated percentage of liver fat - Body weight - NAFLD Fibrosis score - Change in Fibrosis (Kleiner Scale)
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Chirurgische Klinik Mannheim
Recruitment period and number of participants
- Planned study start date:
- 2022-04-01
- Actual study start date:
- 2022-04-01
- Planned study completion date:
- 2024-02-29
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 150
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 65 Years
- Additional Inclusion Criteria:
- - Patients scheduled for RYGB - BMI >35 kg/m2 - Age equal or greater than 18 years - Age equal or lower than 65 years - NAFLD-fibrosis-Score equal or greater than -1.455 - Informed consent
Exclusion Criteria
- Secondary causes of steatosis - Daily alcohol consumption of more than 10g in female / 20g in male - Binge drinking of alkohol - Impaired mental state or language problems - Pregnancy - Expected lack of compliance
Addresses
Primary Sponsor
- Address:
- Chirurgische Klinik Universitätsmedizin MannheimProf. Mirko OttoTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 06213832225
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin Mannheim, Chirurgische KlinikAlida FinzeTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621 383 2225
- Fax:
- -
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Contact for Public Queries
- Address:
- Chirurgische Klinik, Universitätsmedizin MannheimAlida FinzeTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621 383 2225
- Fax:
- -
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Principal Investigator
- Address:
- Universitätsmedizin Mannheim, Chirurgische KlinikAlida FinzeTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 0621 383 2225
- Fax:
- -
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Chirurgische Klinik Universitätsmedizin MannheimTheodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- 06213832225
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.umm.de
Ethics Committee
Address Ethics Committee
- Address:
- Medizinische Ethik-Kommission II Medizinischen Fakultät Mannheim, Forschungsgebäude, Haus 42 - Ebene 3Theodor-Kutzer-Ufer 1-368167 MannheimGermany
- Telephone:
- +49-621-38371770
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2016-09-01
- Ethics committee number:
- 2016-617N-MA
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2017-11-02
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Other trials at our institution are open. We wish to keep the data as long as needed for further studies.
Study protocol and other study documents
- Study protocols:
- Studienprotokoll
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry