NAFLD
Conditions
Brief summary
This study aims to enroll a robust cohort of NAFLD patients who undergo Intragastric Balloon placement through a multidisciplinary program approach to evaluate clinical and patient-reported outcomes for at least one-year post-placement.
Interventions
None listed
Sponsors
Methodist Health System
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Obese (defined as a BMI \>30 kg/m2 ) * Men and women scheduled to undergo immunoglobulin B placement at Methodist Dallas Medical Center(MDMC) * 18 years or older in age * Able to read and understand the study information * Personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study * Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures
Exclusion criteria
* Not meeting inclusion criteria * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Weight | through study completion, up to 18 months | MeasureTotal body weight loss |
| Body Mass Index | 1 year | Measure Body Mass Index |
| Waist to hip ratio | 1 year | Measure Waist-to-hip ratio |
| Aminotransaminases | 1 year | Measure Aminotransaminases |
| Fasting Lipids | 1 year | Measure Fasting Lipids |
| Fasting Glucose | 1 year | Measure Fasting Glucose |
| HbA1c | 1 year | Measure HbA1c |
| Changes in liver histology parameters | 1year | Nonalcoholic Fatty Liver Disease activity score- Min: 1.455 ,Max: 0.675 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORParvez Mantry
Methodist Health System
Outcome results
None listed