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

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Procedure: Abdominal subcutaneous adipose tissue biopsy

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • AdventHealth Translational Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Younger without MetAP2 inhibition; Participants between 18 and 30 years old without MetAP2 inhibition in conditioned media	Procedure: Abdominal subcutaneous adipose tissue biopsy; 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.
Active Comparator: Older without MetAP2 inhibition; Participants 65 years old and without MetAP2 inhibition in conditioned media	Procedure: Abdominal subcutaneous adipose tissue biopsy; 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.
Experimental: Younger with MetAP2 inhibition; Participants between 18 and 30 years old with MetAP2 inhibition in conditioned media	Procedure: Abdominal subcutaneous adipose tissue biopsy; 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.
Experimental: Older with MetAP2 inhibition; Participants 65 years old with MetAP2 inhibition in conditioned media	Procedure: Abdominal subcutaneous adipose tissue biopsy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The effect of MetAP2 inhibition on senescence markers in adipose tissue explants	CXCL14 concentration (pg/ml/mg) in conditioned media	4 weeks
The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants	Adiponectin and resistin concentration (ng/ml/mg) in conditioned media	4 weeks
The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants	Leptin concentration (pg/ml/mg) in conditioned media	4 weeks

Collaborators and Investigators

• Sponsor: AdventHealth Translational Research Institute
• Investigators: Principal Investigator: Lauren Sparks, PhD, Study Principal Investigator

Publications and helpful links

Helpful Links

• Website for AdventHealth Translational Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2020
• Primary Completion (Actual): March 25, 2021
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: July 21, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: adipose tissue; adipocyte
• Other Study ID Numbers: 1389184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No