Brown Adipose Tissue Activity in Response to Semaglutide Administered to Obese Subjects.

May 6, 2025 updated by: Preethi Srikanthan, MD, MS, University of California, Los Angeles

Glucagon like peptide (GLP-1) agonists, such as liraglutide, exenatide, and semaglutide, have been increasingly used as a medication to address the current twin epidemics of diabetes and obesity. Their activities include increasing insulin production by pancreatic beta cells, improving insulin sensitivity in muscles and weight loss. The mechanisms underpinning the weight loss caused by GLP-1 agonists have not yet been fully elucidated, but brown adipose tissue (BAT) appears to play an important role.

We propose to assess BAT activity, using infrared thermography camera images, before individuals start weekly administration of semaglutide, at week 2-4, and week 18-20. We hypothesize that this GLP-1 agonist, semaglutide, will cause an increase in BAT activity and a corresponding increase in basal metabolic rate.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background and Rationale:

Glucagon like peptide (GLP-1) agonists, such as liraglutide, exenatide, and semaglutide, have been increasingly used as a medication to address the current twin epidemics of diabetes and obesity. Their activities include increasing insulin production by pancreatic beta cells, improving insulin sensitivity in muscles and weight loss. The mechanisms underpinning the weight loss caused by GLP-1 agonists have not yet been fully elucidated, but brown adipose tissue (BAT) appears to play an important role.

BAT is a type of adipose tissue which predominates in infants to allow thermoregulation through adaptive thermogenesis, but it is also present in adults. BAT activity also increases insulin sensitivity and whole body energy expenditure, and thus has the potential to treat type 2 diabetes and obesity. Bilateral supraclavicular and axillary BAT account for approximately two thirds of total body BAT content. Although the precise role of BAT in human metabolism and energy balance is unknown, a clear link exists between obesity and BAT dysfunction in humans.

It has been hypothesized that the prominent weight loss activity of GLP-1 agonists in humans is the result of BAT activation. However, studies with various GLP-1 agonists have been equivocal.

With more powerful GLP-1 agonists such as semaglutide entering in clinical practice, a better understanding of the relationship between GLP-1 and BAT is important. If BAT activity is found to be clinically significant as a mechanism of action of GLP-1 agonists, then the addition of adjuvants which enhance BAT activity could optimize the benefit of these medications.

Currently, the main methods available to assess BAT activity are PET-CT with 18F-fluorodeoxyglucose, single-photon-emission CT scanning with tracers such as 123 I-meta-iodobenzylguanidine or 99mTc-tetrofosmin, and/or tissue biopsy 17-19.These techniques have distinct disadvantages as they are expensive and require either the administration of radiopharmaceuticals or tissue sampling. Their utility is, therefore, greatly limited as they can only be conducted on a very small number of subjects and are unable to provide indices of BAT function in real-time. Symonds et al demonstrated the feasibility of using infrared thermography as a safe, reproducible, and robust technique for measuring the temperature of the skin overlying BAT depots in the supraclavicular region and quantifying BAT thermogenesis induced by a cold challenge.

We propose to assess BAT activity, using infrared thermography camera images, before individuals start weekly administration of semaglutide, at week 2- 4, and week 18-20. We hypothesize that this GLP-1 agonist, semaglutide, will cause an increase in BAT activity and a corresponsing increase in basal metabolic rate.

Utilizing a reproducible and non invasive measure of BAT activity, we hope to gain better understanding of BAT activity in concert with the metabolic status of patients commenced on semaglutide. This will not only allow insights into the mechanism of achieving weight loss with semaglutide, it will also allow better understanding of the importance of BAT activity manipulation in the therapy for obesity.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adult >18 years of age, non-diabetic but obese The study is a non-randomized single center study. Subjects who are to be started by their physician or endocrinologist on semaglutide for weight loss, and are willing to participate.

Description

Inclusion Criteria:

  • Subjects scheduled to start semaglutide for weight loss (drug not provided by or paid for by the study)
  • >18 years of age and willing to participate
  • Male or post-menopausal females

Exclusion Criteria:

  • History of prior neck surgery and /or neck irradiation

    • Use of beta blocker agents
    • Use of any other glucose lowering medication
    • History of neuropathic disorders (e.g. diabetic neuropathy)
    • Diabetic patients
    • Individuals without normal thyroid function
    • Individuals with cancer
    • Any significant chronic disease or renal, hepatic or endocrine disease
    • Current smokers
    • Inability of patient to provide consent either for medical reasons or psychiatric reasons

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in supraclavicular temperature with cold exposure
Time Frame: 20weeks
delta temperature
20weeks
change in caloric intake
Time Frame: 20weeks
caloric intake
20weeks
basal metabolic rate
Time Frame: 20 weeks
basal metabolic rate (ml O2/min or joule per hour per kg body mass)
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Preethi Srikanthan, MD, Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

June 10, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Actual)

May 11, 2025

Last Update Submitted That Met QC Criteria

May 6, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-000718

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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