RECRUITING

The Physiology of Human Brown Adipose Tissue

Conditions

Adipose Tissue, Brown Adipose Tissue Obesity Human Cell Atlas

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Physiology of Human Brown Adipose Tissue

Quick Facts

Study Start:2020-03-05

Study Completion:2027-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04352244

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC.	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.

Inclusion Criteria

Exclusion Criteria

1. Healthy participants between age 18 and 75 years undergoing planned clinically indicated procedure at BIDMC.

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.

Contacts and Locations

Study Contact

Mary Elizabeth Patti, MD

CONTACT

6173092635

MaryElizabeth.Patti@joslin.harvard.edu

Amanda L Sheehan, MSN

CONTACT

6173092695

amanda.sheehan@joslin.harvard.edu

Principal Investigator

Mary Elizabeth Patti, MD

PRINCIPAL_INVESTIGATOR

Joslin Diabetes Center

Study Locations (Sites)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

Mary Elizabeth Patti, MD, PRINCIPAL_INVESTIGATOR, Joslin Diabetes Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-05

Study Completion Date2027-06-30

Study Record Updates

Study Start Date2020-03-05

Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

Human Cell Atlas

Additional Relevant MeSH Terms

Adipose Tissue, Brown
Adipose Tissue
Obesity