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

NCT ID: NCT05989035

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-31
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Younger without MetAP2 inhibition

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

Group Type: ACTIVE_COMPARATOR

Abdominal subcutaneous adipose tissue biopsy

Intervention Type: 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 without MetAP2 inhibition

Participants 65 years old and without MetAP2 inhibition in conditioned media

Group Type: ACTIVE_COMPARATOR

Abdominal subcutaneous adipose tissue biopsy

Intervention Type: 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.

Younger with MetAP2 inhibition

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

Group Type: EXPERIMENTAL

Abdominal subcutaneous adipose tissue biopsy

Intervention Type: 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

Participants 65 years old with MetAP2 inhibition in conditioned media

Group Type: EXPERIMENTAL

Abdominal subcutaneous adipose tissue biopsy

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AdventHealth Translational Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Sparks, PhD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

AdventHealth Translational Research Institute

Orlando, Florida, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

https://www.adventhealthresearchinstitute.com/research/translational-research

Website for AdventHealth Translational Research Institute

Other Identifiers

1389184

Identifier Type: -

Identifier Source: org_study_id