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

Aging Clinical Trial

— BIO-AGE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05989035
• Other study ID #: 1389184
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2020
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: AdventHealth Translational Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 2024
• Est. primary completion date: March 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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.

Locations

Country	Name	City	State
United States	AdventHealth Translational Research Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AdventHealth Translational Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of MetAP2 inhibition on senescence markers in adipose tissue explants	CXCL14 concentration (pg/ml/mg) in conditioned media	4 weeks
Primary	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
Primary	The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants	Leptin concentration (pg/ml/mg) in conditioned media	4 weeks

External Links

•   Website for AdventHealth Translational Research Institute