NCT05989035已完成不适用
Effects of MetAP2 Inhibition on Bioenergetics and Aging-associated Characteristics in Adipose Tissue (BIO-AGE) in Healthy Participants
AdventHealth Translational Research Institute2 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2020年8月31日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Younger without MetAP2 inhibition
Active Comparator
Participants between 18 and 30 years old without MetAP2 inhibition in conditioned media
干预措施: Abdominal subcutaneous adipose tissue biopsy (Procedure)
Older without MetAP2 inhibition
Active Comparator
Participants 65 years old and without MetAP2 inhibition in conditioned media
干预措施: Abdominal subcutaneous adipose tissue biopsy (Procedure)
Younger with MetAP2 inhibition
Experimental
Participants between 18 and 30 years old with MetAP2 inhibition in conditioned media
干预措施: Abdominal subcutaneous adipose tissue biopsy (Procedure)
Older with MetAP2 inhibition
Experimental
Participants 65 years old with MetAP2 inhibition in conditioned media
干预措施: Abdominal subcutaneous adipose tissue biopsy (Procedure)
结局指标
主要结局
The effect of MetAP2 inhibition on adipose tissue quality in adipose tissue explants
时间窗: 4 weeks
Adiponectin and resistin concentration (ng/ml/mg) in conditioned media
The effect of MetAP2 inhibition on senescence markers in adipose tissue explants
时间窗: 4 weeks
CXCL14 concentration (pg/ml/mg) in conditioned media
次要结局
未报告次要终点
研究者
研究点 (2)
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