Diabetes Mellitus, Dyslipidaemia, Human Immunodeficiency Virus (HIV), Metabolic Dysfunction Associated Steatotic Liver Disease, Metabolic Syndrome, Obesity & Overweight
Conditions
Keywords
tirzepatdie, human immunodeficiency virus, metabolic dysfunction associated steatotic liver disease
Brief summary
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.
Interventions
DRUGTirzepatide
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.
Sponsors
National Taiwan University Clinical Trial Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Adult people living with HIV, who are virally suppressed, defined as plasma HIV viral load is \< 200 copies/mL within 6 months before enrollment. Participants have to have BMI \> 30 kg/m2.
Exclusion criteria
* Participants cannot have undergone treatment with any incretin-based treatment within the past 90 days before enrollment. Participants cannot have any AIDS-defining illnesses, active malignancy, or history of decompensated liver failure. Participants cannot be pregnant. Participants cannot have history of acute pancreatitis or a family history of medullary thyroid cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Second generation epigenetic aging clock | Baseline, week 33, week 57 | PCGrimAge will be used to study the measured epigetic age and differences with chronological age in years. |
| Third generation epigenetic aging clock | Baseline, week 33, week 57 | DunedinPACE will be used to assess the pace of aging, quantifying years of physiological decline per chronological year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intrahepatic triglycerides | Baseline, week 33, week 57 | Intrahepatic triglycerides will be measured using Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF). |
| Change in body composition assessed by dual-energy X-ray absorptiometry (DXA) | Baseline, week 33, week 57 | Lean body mass and fat mass will be measured in kilograms. |
| Change from baseline in body fat mass measured by bioelectrical impedance analysis (BIA) | Baseline, week 33, week 57 | Bioelectrical impedance analysis will be used to assess fat mass in kilograms. |
| Patient reported outcome | Baseline, week 33, week 57 | Patient reported outcome will be assessed using HIV symptom index |
| Drinking habits | Baseline, week 33, week 57 | Alcohol Use Disorders Identification Test (AUDIT) will be used to assess drinking habits for all participants. |
| Body weight | Baseline, week 8, week 13, week 21, week 33, week 57 | Body weight will be measured in kilograms. |
| Waist circumference | Baseline, week 8, week 13, week 21, week 33, week 57 | Waist circumference will be measured in centimeters |
| Inflammation markers | Baseline, week 33, week 57 | C-reactive protein will be measured in mg/dL. |
| Total bilirubin | Baseline, week 33, week 57 | Total bilirubin will be measured in mg/dL. |
| Alanine transaminase | Baseline, week 33, week 57 | ALT will be measured in U/L. |
| Aspartate transminase | Baseline, week 33, week 57 | AST will be measured in U/L. |
| Fibrosis-4 index | Baseline, week 33, week 57 | Fibrosis-4 index is calculated using AST, ALT, platelet and age. |
| A1c | Baseline, week 33, week 57 | HbA1c will be measured in percentage. |
| Fasting plasma glucose | Baseline, week 33, week 57 | Fasting plasma glucose will be measured in mg/dL. |
| Fasting serum insulin | Baseline, week 33, week 57 | Insulin will be measured in µIU/mL. |
| Change from baseline in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Baseline, week 33, week 57 | HOMA-IR will be calculated using fasting insulin and glucose. |
| Lipid profile | Baseline, week 33, week 57 | Lipid profile includes total cholesterol, HDL, LDL, TG measured in mg/dL. |
| Creatinine | Baseline, week 33, week 57 | Creatinine will be measured in mg/dL. |
| NT-proBNP | Baseline, week 33, week 57 | NT-proBNP will be measured in pg/L. |
| Blood pressure | Baseline, week 8, week 13, week 21, week 33, week 57 | Blood pressure will be measured in millimeter mercury. Both systolic blood pressure and diastolic blood pressure will be measured. |
Countries
Taiwan
Outcome results
None listed