Status:
COMPLETED
A Digital Solution for Individuals With Non Alcoholic Fatty Liver Disease
Lead Sponsor:
Sidekick Health
Collaborating Sponsors:
Hjartamiðstöðin, Iceland
Hjartavernd, Iceland
Conditions:
Non Alcoholic Fatty Liver Disease
Eligibility:
All Genders
18-79 years
Phase:
NA
Brief Summary
Sidekick Health has developed a digital behavioral change program (SK-241) specifically designed for people with metabolic derangements and non-alcoholic fatty liver disease (NAFLD). The SK-241 is del...
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is an umbrella term used to describe a spectrum of liver pathology, characterized by \>5% fat accumulation in the liver (steatosis), among people who drink li...
Eligibility Criteria
Inclusion
- Adults with a NAFLD diagnosis, defined as:
- Confirmed liver steatosis \>5%, with a FibroScan CAP cutoff score of \> 294 decibel (dB)/m among individuals with one or more of the following: Type 2 diabetes OR BMI\>30 OR Metabolic syndrome OR Previous diagnosis of NAFLD within the last 12 months
- for individuals with type 2 diabetes: Stable dose of antidiabetic medication the last 90 days before screening (metformin, glitazones, glucagon like peptide-1 (GLP-1) analogues, sodium-glucose co transporter-2 (SGLT-2) inhibitor, sulfonylurea, insulin)
- Capacity to give informed consent and understands verbal and written Icelandic
- Owns and knows how to operate a smartphone
- Willing and able to comply with the study intervention, all scheduled visits and procedures
Exclusion
- Insulin use
- Known or self-reported cirrhosis
- Alcohol consumption over 14 units/week for males, 7 units/week for women
- Self-reported Hepatitis B (HepB), Hepatitis C (HepC), human immunodeficiency virus (HIV), or autoimmune hepatitis
- Vitamin E intake of \> 400 IU/day - unless stable for 12 weeks prior to baseline
- Taking medications associated with liver steatosis; steroids, methotrexate, tamoxifen, amiodarone, tetracycline, valproic acid
- Self-reported pregnancy
- Participation in a weight loss program
- History of, or any existing medical condition (e.g., ongoing cancer treatment, severe cardiopulmonary- or musculoskeletal disease, stroke, or myocardial infarction in the last 6 months) that, in the opinion of the investigator, would interfere with evaluation of the study intervention or affect the interpretation of the results of the study
Key Trial Info
Start Date :
June 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2023
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT05426382
Start Date
June 20 2022
End Date
April 24 2023
Last Update
April 26 2023
Active Locations (2)
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1
Hjartamiðstöðin
Kopavogur, Iceland, 203
2
Hjartavernd
Kopavogur, Iceland, 203