Status:
COMPLETED
OPTIMIzing muScle Preservation in paTients wIth Cirrhosis
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Obesity
Compensated Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Patients with obesity and cirrhosis benefit from weight loss but are prone to sarcopenia (loss of muscle mass, strength, and function). This study proposes to test a specialized weight loss program A...
Detailed Description
Patients with both cirrhosis and obesity benefit from weight loss, though patients with cirrhosis are prone to sarcopenia due to accelerated rates of protein turnover, and weight loss typically involv...
Eligibility Criteria
Inclusion
- Subjects ≥18 years of age. Per the NIH Policy NOT-OD-18-116, we will include adults ≥ 65 yrs.
- Subjects have a BMI of 30-45. Body mass index (BMI) of 25 to 45 kg/m2. Individuals with a BMI\< 25 kg/m2 are not overweight, and individuals with a BMI \>45 kg/m2 require more aggressive weight-loss interventions such as bariatric surgery.
- Subjects has a diagnosis of cirrhosis based on any of the following methods
- Liver Biopsy is consistent with stage IV fibrosis according to the NASH Clinical Research Network (CRN) scoring system.
- Fibroscan Liver Stiffness \>14kpa
- Endoscopy or imaging finding of varices
Exclusion
- Child-Pugh (CP) score currently \> 6 (i.e., CP Class B/C cirrhosis).
- History of ascites.
- History of portal system encephalopathy.
- Prior history of liver cancer.
- Prior history of non-melanoma skin cancer within the last five years
- Hepatitis C Virus (HCV) patients who have not undergone sustained virological response (SVR).
- Hepatitis B Virus (HBV) Patients who have not received antiviral treatment.
- Patients with diabetes currently on insulin and or sulfonylureas.
- Active alcohol use \>7 drinks per week in the past six months.
- Suspected eating disorders based on Eating Attitudes Test (EAT-26) and The Binge Eating Scale (BES):
- Unable to participate in moderate-intensity PA, e.g., brisk walking
- Participation in a structured weight loss program in the previous six mos.
- Not weight stable (5%) for three months prior to intake.
- Unwilling to be randomized.
- Pregnancy during the previous six mos., currently lactating, or planned pregnancy in the following six mos
- Current use of antipsychotics, untreated depression, or other psychiatric illnesses would preclude weight management participation.
- Adherence to specialized diets that would make it difficult or impossible to follow the guidelines for intervention.
- Evidence of eating disorder or binge eating (as assessed by the Eating Attitudes Test and or Binge Eating Scale.)
- Do not have access to a wireless equipment necessary for remotely delivered group and exercise classes.
Key Trial Info
Start Date :
June 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05367596
Start Date
June 22 2022
End Date
December 16 2022
Last Update
February 9 2023
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160