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

NCT05989035 | Completed

• 1 other identifier: 1389184
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

adipose tissue; adipocyte

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Younger without MetAP2 inhibition

ACTIVE COMPARATOR

Participants between 18 and 30 years old without MetAP2 inhibition in conditioned media

Procedure: Abdominal subcutaneous adipose tissue biopsy

Older without MetAP2 inhibition

ACTIVE COMPARATOR

Participants 65 years old and without MetAP2 inhibition in conditioned media

Procedure: Abdominal subcutaneous adipose tissue biopsy

Younger with MetAP2 inhibition

EXPERIMENTAL

Participants between 18 and 30 years old with MetAP2 inhibition in conditioned media

Procedure: Abdominal subcutaneous adipose tissue biopsy

Older with MetAP2 inhibition

EXPERIMENTAL

Participants 65 years old with MetAP2 inhibition in conditioned media

Procedure: Abdominal subcutaneous adipose tissue biopsy

Interventions

Abdominal subcutaneous adipose tissue biopsy PROCEDURE

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.

Older with MetAP2 inhibition; Older without MetAP2 inhibition; Younger with MetAP2 inhibition; Younger without MetAP2 inhibition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Group 1 cohort are male or female participants between 18 and 30 years old
• Group 2 cohort are male or female participants ≥ 65 years old
• Body mass index (BMI) ≤ 40 kg/m2
• Weight stable (±5 kg) for the last 3 months prior to the Screening visit
• Sedentary (\<20 min of activity, 3x/week).
• Able to speak and understand written and spoken English
• Willing and able to comply with scheduled visits, laboratory tests, and other study procedures
• 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

You may not qualify if:

• Diagnosis of type 1 diabetes mellitus
• Diagnosis of type 2 diabetes mellitus (HbA1C ≥ 6.5)
• Insulin use and use of any other medications for diabetes.
• Use of metformin for polycystic ovarian disease
• Untreated or poorly controlled hypertension (SBP \> 160, DBP \> 100)
• Participants are actively pursuing weight loss and/or lifestyle changes
• Participants have a sensitivity or allergy to lidocaine
• Drug or alcohol abuse (\> 3 drinks per day) within the last 5 years
• 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)
• 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
• Participants who have a TSH \>10 µIU/ml or less than 0.4 µIU/ml
• Triglycerides \>500
• Pregnant or nursing females or females less than 9 months postpartum.
• For females only, any new onset (\< 3 months on a stable regime) use of oral contraceptives (with the exception of hormone replacement therapy)
• Tobacco or nicotine containing product use within the past 3 months

Sponsors & Collaborators

• AdventHealth Translational Research Institute: lead

Study Sites (1)

AdventHealth Translational Research Institute

Orlando, Florida, 32803, United States

Location

Related Links

• Website for AdventHealth Translational Research Institute

Study Officials

• Lauren Sparks, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 14, 2023
• Study Start: August 31, 2020
• Primary Completion: March 25, 2021
• Study Completion: February 1, 2024
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)