Is NCT03587831 recruiting in San Francisco, CA?

Yes, NCT03587831 is currently recruiting participants at its San Francisco, CA location. This nash - nonalcoholic steatohepatitis clinical trial is actively enrolling qualified participants.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

NASH - Nonalcoholic Steatohepatitis Clinical Trial in San Francisco, CA

Q: How do I join the nash - nonalcoholic steatohepatitis clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This NASH - Nonalcoholic Steatohepatitis Study in San Francisco

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 20 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.

Sponsor: University of Minnesota

Who Can Participate

Inclusion Criteria

Age 30 to 70 years at eligibility visit.

At least one of the following:

Diagnosed with NASH with a total NAS ≥ 4 including a ballooning score of at least 1

Diagnosed with T2DM or prediabetes, HbA1c\< 9%

Body Mass Index (BMI): 35.0-60.0 kg/m2 at eligibility visit.

Willingness to accept random assignment to either treatment group.

All patients must have insurance with no

Exclusion Criteria

for obesity related treatments or management of obesity surgery complications. This applies to all participants enrolled in the study

Evidence of liver fat present in the baseline MR images

Suitable for liver biopsy

Willingness to comply with the follow-up protocol and successful completion of the run-in (described below).

Written informed consent.

English speaking Exclusion Criteria:

Cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months.

Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease.

Pulmonary embolus or thrombophlebitis in the past six months.

Cancer of any kind (except basal cell skin cancer or cancer in situ) unless documented to be disease-free for five years.

Significant anemia (hemoglobin 2.0 g/dL or more below normal range) or history of coagulopathy. (Low range for women would be 10, low range for men would be 11)

Serum creatinine \>1.8 mg/dL.

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 2.5x the upper limit of normal. Elevated INR.

Alcohol intake more than one drink or \>20 grams per day

History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection.

Gastric or duodenal ulcer in the past six months.

History of intra-abdominal sepsis (except for uncomplicated appendicitis or diverticulitis more than six months prior to enrollment).

Previous organ transplantation.

Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease.

Currently pregnant or nursing, or planning to become pregnant in the next two years.

History of alcohol, drug, or opioid dependency (excluding nicotine) in the past five years.

Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol.

A score of 17 or greater on the CES-D questionnaire administered on a typical week for the participant.

Presence of any chronic or debilitating disease that would make adherence to the protocol difficult.

Serum c-peptide \<1.0 ng/ml post prandial.

History of endoscopy demonstrating esophagitis or Barrett's changes in the esophagus.

Any history of dysphagia.

Fibrosis score \> 3

Use of Rezdiffra (resmetirom).

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Francisco?

Yes, this clinical trial (NCT03587831) has an active research site in San Francisco, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

NASH - Nonalcoholic Steatohepatitis Treatment Options in San Francisco, CA

If you're searching for nash - nonalcoholic steatohepatitis treatment options in San Francisco, CA, this clinical trial (NCT03587831) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Francisco research site is actively enrolling participants for this clinical trial. You'll receive care from experienced nash - nonalcoholic steatohepatitis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all nash - nonalcoholic steatohepatitis clinical trials near you to find additional studies recruiting in your area.

NASH - Nonalcoholic Steatohepatitis Clinical Trial in San Francisco, CA

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