AgingBIO-AGENCT05989035
Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue in Healthy Participants
A study testing Abdominal subcutaneous adipose tissue biopsy in people with Aging, run by AdventHealth Translational Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Abdominal subcutaneous adipose tissue biopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2020to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
- Major surgery within 4 weeks prior to the Screening Visit
- Anemia (hemoglobin <11 g/dl in men, <10 g/dl in women) at Screening
- Participation in studies involving investigational drug(s) within 30 days prior to the Screening Visit
- Known history of Human Immunodeficiency Virus (HIV), chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C.
- 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)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
AdventHealth Translational Research Institute
Orlando, Florida, 32803
About this study
Official title: 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.
- Conditions
- Aging
- Being tested
- Abdominal subcutaneous adipose tissue biopsy
- Keywords
- adipose tissue, adipocyte
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal subcutaneous adipose tissue biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Younger without MetAP2 inhibition | Active comparator | Participants between 18 and 30 years old without MetAP2 inhibition in conditioned media Receives: Procedure: Abdominal subcutaneous adipose tissue biopsy |
| Older without MetAP2 inhibition | Active comparator | Participants 65 years old and without MetAP2 inhibition in conditioned media Receives: Procedure: Abdominal subcutaneous adipose tissue biopsy |
| Younger with MetAP2 inhibition | Experimental | Participants between 18 and 30 years old with MetAP2 inhibition in conditioned media Receives: Procedure: Abdominal subcutaneous adipose tissue biopsy |
| Older with MetAP2 inhibition | Experimental | Participants 65 years old with MetAP2 inhibition in conditioned media Receives: Procedure: Abdominal subcutaneous adipose tissue biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of MetAP2 inhibition on senescence markers in adipose tissue explants
CXCL14 concentration (pg/ml/mg) in conditioned media
Measured: 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
Measured: 4 weeks
The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants
Leptin concentration (pg/ml/mg) in conditioned media
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start31 Aug 2020
- Primary completion25 Mar 2021
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth Translational Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren Sparks, PhD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05989035
- Sponsor's protocol ID
- 1389184
- Acronym
- BIO-AGE
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2023
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue (BIO-AGE) in Healthy Participants
- ClinicalTrials.gov ID
- NCT05989035
- Acronym / sponsor ID
- BIO-AGE / 1389184
- Conditions
- Aging
- Keywords
- adipose tissue, adipocyte
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- AdventHealth Translational Research InstituteUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 25 Mar 2021 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Younger without MetAP2 inhibition | Active comparator | Procedure: Abdominal subcutaneous adipose tissue biopsyParticipants between 18 and 30 years old without MetAP2 inhibition in conditioned media |
| Older without MetAP2 inhibition | Active comparator | Procedure: Abdominal subcutaneous adipose tissue biopsyParticipants 65 years old and without MetAP2 inhibition in conditioned media |
| Younger with MetAP2 inhibition | Experimental | Procedure: Abdominal subcutaneous adipose tissue biopsyParticipants between 18 and 30 years old with MetAP2 inhibition in conditioned media |
| Older with MetAP2 inhibition | Experimental | Procedure: Abdominal subcutaneous adipose tissue biopsyParticipants 65 years old with MetAP2 inhibition in conditioned media |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal subcutaneous adipose tissue biopsyFatty 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. | Procedure or surgery | Older with MetAP2 inhibition, Older without MetAP2 inhibition, Younger with MetAP2 inhibition, Younger without MetAP2 inhibition |
Primary outcome
The effect of MetAP2 inhibition on senescence markers in adipose tissue explants
Time frame: 4 weeks
CXCL14 concentration (pg/ml/mg) in conditioned media
The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants
Time frame: 4 weeks
Adiponectin and resistin concentration (ng/ml/mg) in conditioned media
The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants
Time frame: 4 weeks
Leptin concentration (pg/ml/mg) in conditioned media
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Website for AdventHealth Translational Research InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren Sparks, PhD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal subcutaneous adipose tissue biopsy in people with Aging, run by AdventHealth Translational Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of MetAP2 inhibition on senescence markers in adipose tissue explants (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.