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临床试验/NCT04352244
NCT04352244招募中不适用

The Physiology of Human Brown Adipose Tissue

Beth Israel Deaconess Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年3月5日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Fasting glucose levels

研究概览

简要总结

Brown fat is a type of fat, found in both children and adults, which can produce heat and regulate the body's metabolism and energy use. White fat is the more common type of fat which is used to store extra calories. Understanding more about differences between brown and white fat may allow us to develop new approaches to improve the body's metabolism.

详细描述

The overarching goal of this study, is to map fat (adipose) tissue differences in humans. The investigators will probe multiple aspects of fat cell (adipocyte) identity by integrating quantitative chemical imaging, single-cell and single-nucleus RNA sequencing (sc and snRNAseq), and site-specific collection of adipocytes and adipocyte precursors.

Deidentified data from these studies will be submitted to the Human Cell Atlas. The investigators anticipate that these studies will ultimately increase understanding of mechanisms by which fat (adipose) tissue regulates systemic metabolism (energy transformation in the body), and promotes risk for metabolic disease. Knowledge gained from this research may be used to set the stage for disease-specific analyses, and aid in the development of personalized medicine for metabolic diseases such as type 2 diabetes.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Body mass index (BMI) greater than or equal to 40 kg/m2
  • History of any local or systemic infectious disease with fever or requiring antibiotic within four weeks of drug administration;
  • Diabetes, either previously diagnosed or hemoglobin A1c greater than or equal to 6.5%
  • Use of oral or parenteral corticosteroids (epidural permitted) or other medication known to cause insulin resistance in the previous 6 weeks.
  • Willingness to provide informed consent and follow study procedures, including attending scheduled visits.
  • Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
  • Hepatic disease, including serum alanine aminotransferase (ALT) or aspartate transaminase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin < 3.0 g/dL; or serum bilirubin > 2.0;
  • Active malignancy (except squamous or basal cell carcinoma of skin)
  • Bleeding disorder, treatment with anticoagulants (if not discontinued prior to surgery), or platelet count <50,000;
  • Current addiction to alcohol or substances of abuse;
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation;
  • Use of an investigational drug within 30 days prior to screening.
  • There will be no involvement of special vulnerable populations such as fetuses, neonates, pregnant women, children, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.
  • Because the goal is to study adult human brown adipose tissue, children are not eligible to participate.

结局指标

主要结局

Fasting glucose levels

时间窗: March 2022

Fasting glucose levels for participants will be analyzed and summarized.

Hemoglobin A1c

时间窗: March 2022

Hemoglobin A1c levels for participants will be analyzed and summarized.

Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for single nucleus RNA analysis.

时间窗: March 2022

Adipose tissue biopsy samples will be processed for single-nucleus RNA analysis of gene expression.

Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy.

时间窗: March 2022

Adipose tissue biopsy samples will be processed for Raman spectroscopy analysis.

Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation

时间窗: March 2022

Adipose tissue biopsy samples will be processed for ex vivo differentiation.

Insulin resistance

时间窗: March 2022

Insulin resistance of participants, assessed by homeostatic model of insulin resistance (HOMA-IR), will be analyzed and summarized.

Body mass index (BMI)

时间窗: March 2022

Weight and height will be combined to report BMI in kg/m\^2. BMI of participants will be analyzed and summarized.

Demographic characteristics

时间窗: March 2022

Demographic characteristics of participants will be analyzed and summarized.

次要结局

  • DNA analysis(March 2022)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mary Elizabeth Patti

Associate Professor of Medicine

Beth Israel Deaconess Medical Center

研究点 (1)

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