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

• Sponsor: AdventHealth Translational Research Institute (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05989035
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 4
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging	Procedure: Abdominal subcutaneous adipose tissue biopsy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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 inhibitionThis 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)
• Primary Purpose: Basic Science
• Official Title: Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue (BIO-AGE) in Healthy Participants
• Actual Study Start Date: Aug 31, 2020
• Actual Primary Completion Date: Mar 25, 2021
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. The effect of MetAP2 inhibition on senescence markers in adipose tissue explants [4 weeks]

   CXCL14 concentration (pg/ml/mg) in conditioned media

2. The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants [4 weeks]

   Adiponectin and resistin concentration (ng/ml/mg) in conditioned media

3. The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants [4 weeks]

   Leptin concentration (pg/ml/mg) in conditioned media

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AdventHealth Translational Research Institute	Orlando	Florida	United States	32803

Sponsors and Collaborators

• AdventHealth Translational Research Institute

Investigators

• Principal Investigator: Lauren Sparks, PhD, Study Principal Investigator

Study Documents (Full-Text)

• Informed Consent Form - Feb 4, 2021

More Information

Additional Information:

• Website for AdventHealth Translational Research Institute

Publications

None provided.

• Responsible Party: AdventHealth Translational Research Institute
• ClinicalTrials.gov Identifier: NCT05989035
• Other Study ID Numbers: 1389184
• First Posted: Aug 14, 2023
• Last Update Posted: Aug 17, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AdventHealth Translational Research Institute: adipose tissue; adipocyte

Study Results

No Results Posted as of Aug 17, 2023