We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05419726
Recruitment Status : Recruiting
First Posted : June 15, 2022
Last Update Posted : February 13, 2023
Sponsor:
Information provided by (Responsible Party):
Preethi Srikanthan, MD, MS, University of California, Los Angeles

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

ABSTRACT 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 loss1,2. 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 role1,2.

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.


Condition or disease Intervention/treatment
Obesity Drug: Semaglutide Injectable Product

Show Show detailed description
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brown Adipose Tissue Activity in Response to Semaglutide Administered to Obese Subjects.
Actual Study Start Date : February 1, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Semaglutide Injectable Product

    STUDY PROCEDURES

    Patients who are to be started on semaglutide by their physician will be invited to participate in the study, and will be given a consent form. If they agree to proceed, they will be scheduled for a visit to undergo BMR and thermal imaging of BAT (Visit 1) prior to starting semaglutide. When the patient returns at week 2-4 (Visit 2) and week 18-20 (Visit 3), final BMR and thermal imaging of BAT will be done. Subjects will also perform a 24 hour food recall at each visit.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. change in supraclavicular temperature with cold exposure [ Time Frame: 20weeks ]
    delta temperature

  2. change in caloric intake [ Time Frame: 20weeks ]
    caloric intake

  3. basal metabolic rate [ Time Frame: 20 weeks ]
    basal metabolic rate (ml O2/min or joule per hour per kg body mass)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult males >18 years of age, non-diabetic but obese The study is a non-randomized single center study. Patients who are to be started by their physician or endocrinologist on semaglutide for weight loss, and are willing to participate, will be consented and undergo evaluation with cold stimulus and thermal imaging of BAT prior to starting semaglutide, at week 2-4, and week 18-20.
Criteria

Inclusion Criteria:

  • Patients scheduled to start semaglutide for weight loss
  • >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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05419726


Contacts
Layout table for location contacts
Contact: Preethi Srikanthan, MD 310-825-7922 psrikanthan@mednet.ucla.edu
Contact: Julie Sorg, MSN 310-206-2235 jsorg@mednet.ucla.edu

Locations
Layout table for location information
United States, California
UCLA Health Recruiting
Los Angeles, California, United States, 90095
Contact: Julie Sorg, MSN    310-259-7327    jsorg@mednet.ucla.edu   
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Layout table for investigator information
Principal Investigator: Preethi Srikanthan, MD Principal Investigator
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:

Layout table for additonal information
Responsible Party: Preethi Srikanthan, MD, MS, Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT05419726    
Other Study ID Numbers: PRE22-003167
First Posted: June 15, 2022    Key Record Dates
Last Update Posted: February 13, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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