Obesity Clinical Trial
— OPTIMISTICOfficial title:
OPTIMIzing muScle Preservation in paTients wIth Cirrhosis
Verified date | February 2023 |
Source | University of Kansas Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 Alternative-day Modified Fasting (ADMF) designed to promote weight loss and preserve skeletal muscle mass, strength, and function in patients with both Child-Pugh (CP) class A cirrhosis and obesity. This study will compare the effectiveness of the ADMF to Continuous Energy Restriction (CER) for 24-weeks. Both arms will receive a high-protein, high-BCAA diet, a late-night snack, supervised aerobic and resistance exercise, increased physical activity through self-monitoring, and group behavioral counseling. The primary aim of this trial is to evaluate the feasibility and acceptability of ADMF and CER for 6 months in patients with cirrhosis and obesity. The secondary aim is to compare changes in body composition in both diets.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 16, 2022 |
Est. primary completion date | December 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Kansas Medical Center | Kansas City | Kansas |
Lead Sponsor | Collaborator |
---|---|
University of Kansas Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compare changes in body composition in both diets | The primary outcome is the percent of weight lost as fat-free mass at 24 weeks. Body weight and body composition (as assessed by dual x-ray absorptiometry) will be measured at baseline, week 12, and post-intervention. Percent weight loss from fat-free mass will be calculated as [? fat-free mass / ? weight loss] for all participants who lose at least 3% of initial body weight. If >70% of participants lose at least 80% of weight from fat mass (or no more than 20% of weight loss coming from lean mass) we will proceed to testing this intervention in an adequately powered trial. | Baseline, 12 weeks and 24 weeks. | |
Secondary | Frailty, Subjective | Karnofsky Performance Status (KPS). The KPS allows patients to be classified as to their functional impairment. This can be used to compare effectiveness of different therapies and to assess the prognosis in individual patients. The lower the KPS, the worse the survival for most serious illnesses. | Baseline, 12 weeks and 24 weeks. | |
Secondary | Frailty, Objective | The Liver Frailty Index (LFI), composed of 3 performance-based tests (grip strength, chair stands, and balance), is a tool specifically developed in patients with cirrhosis to objectively measure physical function, a critical determinant of health outcomes. | Baseline, 12 weeks and 24 weeks. | |
Secondary | Health Related Quality of Life | Health-related quality of life (HRQOL) is a multi-dimensional concept commonly used to examine the impact of health status on quality of life. HRQOL is often measured by four core questions that asked about general health status and number of unhealthy days. | Baseline, 12 weeks and 24 weeks. |
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