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Trial record 8 of 277 for:    Non-alcoholic Steatohepatitis | United States

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

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ClinicalTrials.gov Identifier: NCT03587831
Recruitment Status : Recruiting
First Posted : July 16, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months. The primary goal for the trial is to determine if the investigators can recruit, randomize, and retain participants to perform invasive and non-invasive measurements of NASH and fibrosis, deliver lifestyle modification and demonstrate the safety of VSG. The investigators wish to also understand which of these two interventions is more effective in achieving, 12 months after entry into the trial, a reduction in NAS composed of the non-weighted scores: (1) steatosis 0-3 (2) Inflammation 0-3 and (3) ballooning 0-2. Secondary goals include comparing the two treatment groups for changes in other measured outcomes including MRI assessments of intrahepatic triglyceride and liver elasticity and serum markers. As a pilot study, a sample size of 19 in each group should offer significant information as to the difference in NAS score reduction between to two groups and achieve adequate power to distinguish clinically significant changes in the primary and secondary outcome measures. These data support the overarching objective i.e. to provide evidence that a larger, longer-term clinical outcomes trial is feasible. A goal is for a longer term follow up for 5 years to assess the durability of treatment effects and treatment differences.

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Procedure: Vertical Sleeve Gastrectomy Behavioral: Lifestyle Modification Counseling Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: VSG + LSM

Procedure/Surgery: Vertical Sleeve Gastrectomy will be performed using five laparoscopic ports. The short gastric and epiploic vessels will be taken down With a 40 French Bougie in place, the greater curvature will be excised starting 6 cm proximal to the pylorus.

Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention will align with methods listed in the LSM arm description. However, participants assigned to the VSG will not have calorie ceilings during the first 6 months of rapid weight loss, and they will receive additional instruction regarding food volume and adequate protein intake.

Procedure: Vertical Sleeve Gastrectomy
Surgical Procedure: Vertical Sleeve Gastrectomy

Behavioral: Lifestyle Modification Counseling
Behavioral Intervention: Lifestyle Modification Counseling

Active Comparator: LSM
Behavioral: Lifestyle Modification Counseling - The intensive lifestyle intervention is modeled after the LookAHEAD trial, with modules modified for participants undergoing surgery, and designed to produce maximum achievable weight loss. Both groups will increase their level of moderate-intensity physical activity (such as walking) to a total of 325 minutes per week. All lifestyle-medical management participants will be given calorie intake targets of 1200, 1500, or 1800 kilocalories per day, depending on body weight, with the goal of producing a weight loss of 1 to 2 pounds per week. There will be 24 weekly counseling meetings during the first 6 months, bi-weekly meetings between months 7 and 9, and monthly meetings between months 10 and 12.
Behavioral: Lifestyle Modification Counseling
Behavioral Intervention: Lifestyle Modification Counseling




Primary Outcome Measures :
  1. Histologic improvements in NAFLD Activity Score (NAS) [ Time Frame: Month 12 ]

    The scale used is NAS - this is the NAFLD (Nonalcoholic Fatty Liver Disease) Activity Score.

    The NAS was developed to provide a numerical score for patients who most likely have NASH. Accordingly, NAS is the sum of the separate scores for steatosis (0-3), hepatocellular ballooning (0-2) and lobular inflammation (0-3). NAS scores of 0-2 are largely considered not diagnostic of NASH, scores of 3-4 are often considered not diagnostic, borderline, or potentially positive for NASH. Scores of 5-8 are largely considered diagnostic of NASH.

    It is expected that the addition of VSG to lifestyle modification will result in more robust histologic improvements in NAFLD Activity Score (NAS) compared to lifestyle modification alone.




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 40 to 67 years at eligibility visit.
  2. Diagnosed with T2DM (type 2 diabetes mellitus) or prediabetes for at least 6 months prior to enrollment, under the active care of a doctor for at least the six months prior to enrollment, HbA1c< 9% and NOT requiring insulin.
  3. AST >32 IU/L or an ALT>39.9 IU/L
  4. Body Mass Index (BMI): 30.0-39.9 kg/m2 at eligibility visit.
  5. Willingness to accept random assignment to either treatment group.
  6. All patients must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study
  7. Expect to live or work within approximately one-hour traveling time from the study clinic for the duration of the one-year trial.
  8. Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).
  9. Written informed consent.

Exclusion Criteria:

  1. Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.
  2. Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.
  3. Cardiac stress test indicating that surgery would not be safe.
  4. Pulmonary embolus or thrombophlebitis in the past six months.
  5. Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.
  6. Significant anemia (hemoglobin 1.0 g/dL or more below normal range) or history of coagulopathy.
  7. Serum creatinine >1.5 mg/dL.
  8. Serum total bilirubin greater than the upper limit of normal in the absence of Gilbert's syndrome, or alkaline phosphatase or ALT or AST greater than twice the upper limit of normal. Elevated INR.
  9. Alcohol intake more than one drink or >20 grams per day
  10. History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.
  11. Gastric or duodenal ulcer in the past six months.
  12. History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).
  13. Previous organ transplantation.
  14. Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.
  15. Currently pregnant or nursing, or planning to become pregnant in the next two years.
  16. History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.
  17. Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.
  18. Depression: A CES-D score more than 17.
  19. Current participation in a conflicting research protocol.
  20. Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.
  21. 12-lead EKG indicating that surgery would not be safe.
  22. Serum c-peptide <1.0 ng/ml post prandial.
  23. Exclusions may also be made at the discretion of the attending physician or the eligibility committee.
  24. Contraindication to MRI scanning. MRI contraindications are assessed by MR technologists on the day of scanning using a standard safety screening form.
  25. Gastroesophageal reflux disease requiring medications. History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus. Any history of dysphagia.
  26. More than 2 cups of coffee per day.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03587831


Contacts
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Contact: Sara Eischen 612-626-2498 bengt008@umn.edu
Contact: Mary Farnsworth 612-624-9695 ewigx005@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Sara Eischen    612-626-2498    bengt008@umn.ed   
Contact: Mary Farnsworth    612-624-9695    ewigx005@umn.edu   
Principal Investigator: Sayeed Ikramuddin, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
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Principal Investigator: Sayeed Ikramuddin, M.D., M.H.A. University of Minnesota - Clinical and Translational Science Institute

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03587831     History of Changes
Other Study ID Numbers: STUDY00002886
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases