Investigating the Link Between Type 2 Immunity and NAFLD in Human Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-70
SponsorMayo Clinic
About this trial
This study is being done to better understand the relationship between inflammation in adipose tissue (AT), abnormal deposition of fat around the liver and how this affects its appearance and function and ultimately insulin resistance.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Undergoing gastric bypass surgery
Confirmed AUROC F=0 or F>2 liver fibrosis
Age 30-70 years
BMI greater than 40 kg/m2
Disqualifiers
Autoimmune diseases
Hepatitis B or C positive
Heavy alcohol use
Active smoking history
Trial population
Fourteen subjects with F=0 (no fibrosis) and forty-six patients undergoing gastric bypass Surgery with confirmed Area under the Receiver Operating Characteristic Curve (AUROC) F\>2 (moderate fibrosis), age 30-70yrs, both genders, BMI greater than 40 kg/m2 will be enrolled in the study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bariatric surgery
Procedure/SurgeryEvaluate liver fibrosis by elastography before gastric bypass surgery.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Weight loss surgery1 intervention
Trial outcomes
Primary outcomes
1
Liver fibrosis
evaluate the liver fibrosis by elastography before surgical intervention
Time frame
Baseline2
Adipose tissue inflammation
Evaluate markers of adipose tissue inflammation by mRNA levels
Time frame
BaselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov