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Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue in Healthy Participants

Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue (BIO-AGE) in Healthy Participants

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05989035
Acronym
BIO-AGE
Enrollment
31
Registered
2023-08-14
Start date
2020-08-31
Completion date
2025-12-31
Last updated
2025-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

adipose tissue, adipocyte

Brief summary

This study is being done to collect Adipose tissue from young and older individuals and gather data on the effect of methionine aminopeptidase protein (MetAP2) inhibition on that Adipose tissue in the laboratory.

Interventions

Fatty tissue biopsy- Participant will be placed in a supine position with arms placed at side while abdominal skin is marked with a skin marker and cleansed with chlorhexidine. Afterwards, the abdominal fatty tissue biopsy will be performed. Collect fatty tissue from young and older individuals and gather data on the effect of methionine aminopeptidase protein (MetAP2) inhibition on that fatty tissue in the laboratory.

Sponsors

AdventHealth Translational Research Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

This is a prospective single-site study, consisting of two groups of participants. Group 1 will be younger participants between the ages of 18 and 30 years old. Group will be older participants that are 65 years and older. Each participant will have an abdominal subcutaneous adipose tissue (AT) biopsies. Two aliquots from each biopsy will be incubated for conditioned media with and without MetAP2 inhibition

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Group 1 cohort are male or female participants between 18 and 30 years old 2. Group 2 cohort are male or female participants ≥ 65 years old 3. Body mass index (BMI) ≤ 40 kg/m2 4. Weight stable (±5 kg) for the last 3 months prior to the Screening visit 5. Sedentary (\<20 min of activity, 3x/week). 6. Able to speak and understand written and spoken English 7. Willing and able to comply with scheduled visits, laboratory tests, and other study procedures 8. Participant has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study

Exclusion criteria

1. Diagnosis of type 1 diabetes mellitus 2. Diagnosis of type 2 diabetes mellitus (HbA1C ≥ 6.5) 3. Insulin use and use of any other medications for diabetes. 4. Use of metformin for polycystic ovarian disease 5. Untreated or poorly controlled hypertension (SBP \> 160, DBP \> 100) 6. Participants are actively pursuing weight loss and/or lifestyle changes 7. Participants have a sensitivity or allergy to lidocaine 8. Drug or alcohol abuse (\> 3 drinks per day) within the last 5 years 9. Any unstable medical condition (i.e., coronary heart disease, stroke, chronic renal failure \[serum creatinine should not exceed 1.5-fold the upper laboratory norm and estimated eGFR should not be lower than 60 mL/min/1.73 m2 at screening\], chronic hepatic disease, severe pulmonary disease, bleeding disorders, autoimmune disease, active rheumatoid arthritis or other inflammatory rheumatic disorder, or gastrointestinal disease requiring medication) 10. Participants currently taking anti-inflammatory medications within 2 days prior to biopsy or antiplatelet medications within 7 days prior to biopsy, that cannot be safely stopped for study procedures 11. Participants who have a TSH \>10 µIU/ml or less than 0.4 µIU/ml 12. Triglycerides \>500 13. Pregnant or nursing females or females less than 9 months postpartum. 14. For females only, any new onset (\< 3 months on a stable regime) use of oral contraceptives (with the exception of hormone replacement therapy) 15. Tobacco or nicotine containing product use within the past 3 months 16. Major surgery within 4 weeks prior to the Screening Visit 17. Anemia (hemoglobin \<11 g/dl in men, \<10 g/dl in women) at Screening 18. Participation in studies involving investigational drug(s) within 30 days prior to the Screening Visit 19. Known history of Human Immunodeficiency Virus (HIV), chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C. 20. Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years) 21. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study visits

Design outcomes

Primary

MeasureTime frameDescription
The effect of MetAP2 inhibition on senescence markers in adipose tissue explants4 weeksCXCL14 concentration (pg/ml/mg) in conditioned media
The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants4 weeksAdiponectin and resistin concentration (ng/ml/mg) in conditioned media

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026