Phase
Condition
Hyponatremia
Primary Biliary Cholangitis
Hepatic Fibrosis
Treatment
Control Group
Intervention Group
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Evidence of steatosis (CAP score ≥ 290 by vibration controlled transient elastography) OR Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography [F2 score ≥ 8kPa]) AND meets one of the following criteria: i. overweight or obese (BMI≥23 in Asians or BMI≥25 in other racial groups), OR ii. presence of type II diabetes mellitus, OR iii. lean/normal weight with presence of at least two metabolic risk abnormalities, OR:
Waist circumference ≥90/80 cm in Asians or ≥102/88 cm in other racial groups)
Blood pressure ≥130/85 mmHg or specific drug treatment
Plasma triglycerides ≥150 mg/dl or specific drug treatment
Plasma HDL-cholesterol <40 mg/dl for men and <50 mg/dl for women, or specific drugtreatment
Prediabetes (fasting glucose levels 100-125 mg/dl , or HbA1c 5.7-6.4% ) iv. AUDIT-C ≥4 for men and ≥3 for women AND AUDIT-10 = 8-15
AND/OR 2. Evidence of liver fibrosis (FIB-4 index ≥ 1.6 or fibrosis grade ≥ F2 by vibration controlled transient elastography) and presence of one of the following:
chronic HBV (HBsAg+ or taking anti-HBV therapy), or
chronic HCV (1. detectable HCV RNA > 4 months or a 2. history of HCV infection andtaking anti-HCV therapy)
At least 18 years old 4. Speak and read English or Spanish 5. Access tosmartphone with data plan or Wi-Fi access 6. Willing to receive up to 12 textmessages per week
Exclusion
Exclusion Criteria:
Pregnant or planning to become pregnant in next 12 months (by self-report)
Medical contraindications to home-based exercise or low-fat,high-vegetable-and-fruit diet
Recent or planned surgery that would interfere with home-based exercise or alow-fat, high vegetable and fruit diet
Current or prior history of primary liver cancer or cancer that is metastaticto the liver
AUDIT-10 score >15
Family or household member already enrolled into study
Study Design
Study Description
Connect with a study center
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available

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