This study is a pilot, open-lable, two-arm study. The investigators will enroll virally suppressed people living with HIV and obesity to evaluate the effect of tirzepatide on epigenetic aging, assessed by DNA methylation-based clocks using peripheral blood. In parallel, imaging studies will be performed to assess changes in body composition and intrahepatic fat content.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Tirzepatide will be given to the study arm after 8 weeks of diet and nutrition services. Study arm will receive a total of 25 weeks of tirzepatide.
National Taiwan University Hospial
Taipei, Taiwan
Second generation epigenetic aging clock
PCGrimAge will be used to study the measured epigetic age and differences with chronological age in years.
Time frame: Baseline, week 33, week 57
Third generation epigenetic aging clock
DunedinPACE will be used to assess the pace of aging, quantifying years of physiological decline per chronological year.
Time frame: Baseline, week 33, week 57
Intrahepatic triglycerides
Intrahepatic triglycerides will be measured using Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF).
Time frame: Baseline, week 33, week 57
Change in body composition assessed by dual-energy X-ray absorptiometry (DXA)
Lean body mass and fat mass will be measured in kilograms.
Time frame: Baseline, week 33, week 57
Change from baseline in body fat mass measured by bioelectrical impedance analysis (BIA)
Bioelectrical impedance analysis will be used to assess fat mass in kilograms.
Time frame: Baseline, week 33, week 57
Patient reported outcome
Patient reported outcome will be assessed using HIV symptom index
Time frame: Baseline, week 33, week 57
Drinking habits
Alcohol Use Disorders Identification Test (AUDIT) will be used to assess drinking habits for all participants.
Time frame: Baseline, week 33, week 57
Body weight
Body weight will be measured in kilograms.
Time frame: Baseline, week 8, week 13, week 21, week 33, week 57
Waist circumference
Waist circumference will be measured in centimeters
Time frame: Baseline, week 8, week 13, week 21, week 33, week 57
Inflammation markers
C-reactive protein will be measured in mg/dL.
Time frame: Baseline, week 33, week 57
Total bilirubin
Total bilirubin will be measured in mg/dL.
Time frame: Baseline, week 33, week 57
Alanine transaminase
ALT will be measured in U/L.
Time frame: Baseline, week 33, week 57
Aspartate transminase
AST will be measured in U/L.
Time frame: Baseline, week 33, week 57
Fibrosis-4 index
Fibrosis-4 index is calculated using AST, ALT, platelet and age.
Time frame: Baseline, week 33, week 57
A1c
HbA1c will be measured in percentage.
Time frame: Baseline, week 33, week 57
Fasting plasma glucose
Fasting plasma glucose will be measured in mg/dL.
Time frame: Baseline, week 33, week 57
Fasting serum insulin
Insulin will be measured in µIU/mL.
Time frame: Baseline, week 33, week 57
Change from baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR will be calculated using fasting insulin and glucose.
Time frame: Baseline, week 33, week 57
Lipid profile
Lipid profile includes total cholesterol, HDL, LDL, TG measured in mg/dL.
Time frame: Baseline, week 33, week 57
Creatinine
Creatinine will be measured in mg/dL.
Time frame: Baseline, week 33, week 57
NT-proBNP
NT-proBNP will be measured in pg/L.
Time frame: Baseline, week 33, week 57
Blood pressure
Blood pressure will be measured in millimeter mercury. Both systolic blood pressure and diastolic blood pressure will be measured.
Time frame: Baseline, week 8, week 13, week 21, week 33, week 57
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