Status:
ACTIVE_NOT_RECRUITING
Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue in Healthy Participants
Lead Sponsor:
AdventHealth Translational Research Institute
Conditions:
Aging
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT05989035
Start Date
August 31 2020
End Date
December 1 2025
Last Update
March 13 2025
Active Locations (1)
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1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32803