Obesity Clinical Trial
Official title:
The Physiology of Human Brown Adipose Tissue
NCT number | NCT04352244 |
Other study ID # | 2009P-000101 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 5, 2020 |
Est. completion date | March 2024 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | March 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion criteria: 1. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC. Exclusion Criteria: 1. Body mass index (BMI) greater than or equal to 40 kg/m2 2. History of any local or systemic infectious disease with fever or requiring antibiotic within four weeks of drug administration; 3. Diabetes, either previously diagnosed or hemoglobin A1c greater than or equal to 6.5% 4. Use of oral or parenteral corticosteroids (epidural permitted) or other medication known to cause insulin resistance in the previous 6 weeks. 5. Willingness to provide informed consent and follow study procedures, including attending scheduled visits. 6. Chronic kidney disease stage 4 or 5 (including end-stage renal disease); 7. 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; 8. Active malignancy (except squamous or basal cell carcinoma of skin) 9. Bleeding disorder, treatment with anticoagulants (if not discontinued prior to surgery), or platelet count <50,000; 10. Current addiction to alcohol or substances of abuse; 11. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation; 12. Use of an investigational drug within 30 days prior to screening. 13. 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. 14. Because the goal is to study adult human brown adipose tissue, children are not eligible to participate. |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center | Chan Zuckerberg Initiative, Joslin Diabetes Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for single nucleus RNA analysis. | Adipose tissue biopsy samples will be processed for single-nucleus RNA analysis of gene expression. | March 2022 | |
Primary | Collect human brown and white adipose tissue to prepare progenitor and differentiated cells for Raman spectroscopy. | Adipose tissue biopsy samples will be processed for Raman spectroscopy analysis. | March 2022 | |
Primary | Collect human brown and white adipose tissue to prepare cells for ex vivo differentiation | Adipose tissue biopsy samples will be processed for ex vivo differentiation. | March 2022 | |
Primary | Insulin resistance | Insulin resistance of participants, assessed by homeostatic model of insulin resistance (HOMA-IR), will be analyzed and summarized. | March 2022 | |
Primary | Hemoglobin A1c | Hemoglobin A1c levels for participants will be analyzed and summarized. | March 2022 | |
Primary | Fasting glucose levels | Fasting glucose levels for participants will be analyzed and summarized. | March 2022 | |
Primary | Body mass index (BMI) | Weight and height will be combined to report BMI in kg/m^2. BMI of participants will be analyzed and summarized. | March 2022 | |
Primary | Demographic characteristics | Demographic characteristics of participants will be analyzed and summarized. | March 2022 | |
Secondary | DNA analysis | DNA will be isolated and stored from blood samples. If specific genes are differentially regulated as a function of metabolic state or anatomical location of biopsy, locus-specific or genome-wide genotyping may be performed to assess potential regulatory single-nucleotide polymorphisms (SNP). | March 2022 |
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