NCT03793127进行中（未招募）不适用
BAT as a Therapeutic for the Metabolic and Cardiac Dysfunction With Senescence Pilot
AdventHealth Translational Research Institute1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年1月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups.
研究概览
简要总结
The primary purpose of this protocol is to develop a reliable method to determine BAT mass in young and older adults by magnetic resonance imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Capable of providing informed consent and has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board and provided Health Insurance Portability and Accountability Act authorization (HIPAA) or other privacy authorization prior to any participation in study.
- •Adult female or male, 20-40 or 60-80 years of age, inclusive at time of screening.
- •BMI ≥19.0 and ≤34.9 kg/m2, inclusive at time of screening.
- •Stable weight (No gain/loss of ≥ 10 lbs within 6 months prior to screening).
- •Non-smokers as defined by not smoked any tobacco or nicotine-containing products vape pens or vaporizers within 3 months prior to screening.
排除标准
- •History of type 1 or type 2 diabetes per self-report at screening visit 1; or Hgb A1c ≥ 6.5% at screening..
- •Actively pursuing weight loss and/or lifestyle changes at time of screening.
- •Weight > 450 lbs at screening.
- •Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic).
- •Mini Mental State Exam (MMSE) <21, only applicable for those 60-80 years of age
- •Significant cardiovascular event (e.g. myocardial infarction, stroke) ≤ 6 months prior to screening visit; or stated history of congestive heart failure; or evidence of cardiovascular disease assessed during the ECG at screening.
- •Current infection (requiring prescription antimicrobial or antiviral medication, or hospitalization), or corticosteroid treatment (with the exception of inhaled or topical steroids) in the last 3 months prior to screening visit.
- •Prescription strength anti-inflammatory medication in the 6 weeks prior to screening.
- •Surgery requiring >2 days of hospitalization in the last 3 weeks prior to screening visit.
- •Active malignancy or autoimmune disease.
- •History of chronic, contagious, infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV, per self-report.
- •History of uncontrolled severe diarrhea, nausea or vomiting within 3 months of screening.
- •Uncontrolled severe (including stage III or above) gastrointestinal absorption-related disorders, within 3 months of screening, such as: obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome, gastroesophageal reflux disease, gastroparesis, peptic ulcer disease, celiac disease, intestinal dysmotility, diverticulitis, ischemic colitis.
- •History of drug or alcohol abuse (> 3 drinks per day) within the last 5 years.
- •Pregnant, lactating or is within 6 weeks postpartum prior to the screening visit.
- •Metal implants (pace-maker, aneurysm clips) based on Investigator's judgment at screening.
- •Unable to participate in MRI assessments due to physical limitations of equipment tolerances (e.g. MRI bore size) based on Investigator's judgment at screening.
- •Unable to tolerate MRI imaging or claustrophobia.
- •Urine albumin-to-creatinine ratio (UACR) ≥300 mg/g in a single urine specimen (per National Kidney Foundation guideline) at screening.
- •Impaired renal function: estimated glomerular filtration rate (eGFR) ≤ 50 ml/min/1.73m2 determined at screening.
- •Significantly impaired liver function in the opinion of the study PI (mild asymptomatic fatty liver is acceptable), or hepatic enzyme tests are ≥2.5 times normal limit at time of screening.
- •Total cholesterol level is ˃300 mg/dL at screening.
- •Participant has inadequately treated hyperthyroidism (thyroid stimulating hormone [TSH] below normal range) or hypothyroidism (TSH>ULN (upper limit normal) to <10U/mL and symptomatic, or TSH >10 U/mL) at time of screening.
结局指标
主要结局
Collection of imaging of BAT by magnetic resonance imaging from 10 participants in each of young and old study groups.
时间窗: 30 minutes
Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2\* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method. The participant may be removed from the magnet and repositioned during the exam in order to determine the same day variability of this method.
次要结局
未报告次要终点
研究者
研究点 (1)
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