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ObesityNCT05419726

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

An observational study of Obesity, run by University of California, Los Angeles at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Obesity
What is being tested?
Semaglutide Injectable Product (not provided by the study)
Type of treatment
Injection or infusion
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Feb 2023to 1 Feb 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Preethi Srikanthan, MD contact

310-825-7922

psrikanthan@mednet.ucla.edu

Julie Sorg, MSN contact

310-206-2235

jsorg@mednet.ucla.edu

United States1 site, 1 recruiting
  • UCLA Health

    Los Angeles, California, 90095

    Julie Sorg, MSN, jsorg@mednet.ucla.edu

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Conditions
Obesity
Being tested
Semaglutide Injectable Product (not provided by the study)
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semaglutide Injectable Product (not provided by the study)Drug

    Study Procedure:

    Subjects that are to be started on semaglutide by their physician will be invited to participate in the study. If the subject is eligible and signs the consent form they will be enrolled in the study. There are three (3) study visits including Baseline/Visit 1 (prior to starting semaglutide), Visit 2 (at week 2-4) and Visit 3 (at week 18-20). The subjects undergo these tests at each visit: weight circumference measured, BMR testing, thermal imaging of BAT, and perform a 24 hour food recall.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in supraclavicular temperature with cold exposure

    delta temperature

    Measured: 20weeks

  2. change in caloric intake

    caloric intake

    Measured: 20weeks

  3. basal metabolic rate

    basal metabolic rate (ml O2/min or joule per hour per kg body mass)

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2022
  2. Study start1 Feb 2023
  3. Primary completion1 Jan 2026 (estimated)
  4. Study completion1 Feb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05419726
Sponsor's protocol ID
22-000718
Status last verified
May 2025
First submitted
10 Jun 2022
Last updated
11 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Gonzalez-Garcia I, Milbank E, Dieguez C, Lopez M, Contreras C. Glucagon, GLP-1 and Thermogenesis. Int J Mol Sci. 2019 Jul 13;20(14):3445. doi: 10.3390/ijms20143445.

    PubMed 31337027
  • Stafeev I, Sorkina E, Koksharova E, Tumanyan T, Sklyanik I, Menshikov M, Mayorov A, Parfyonova Y, Shestakova M. The Effects of Glucagon-Like Peptide Type 1 (GLP-1) and its Analogues in Adipose Tissue: Is there a way to Thermogenesis? Curr Mol Med. 2021;21(7):527-538. doi: 10.2174/1566524020666201201095029.

    PubMed 33261539
  • Cypess AM, Lehman S, Williams G, Tal I, Rodman D, Goldfine AB, Kuo FC, Palmer EL, Tseng YH, Doria A, Kolodny GM, Kahn CR. Identification and importance of brown adipose tissue in adult humans. N Engl J Med. 2009 Apr 9;360(15):1509-17. doi: 10.1056/NEJMoa0810780.

    PubMed 19357406
  • Blondin DP, Labbe SM, Noll C, Kunach M, Phoenix S, Guerin B, Turcotte EE, Haman F, Richard D, Carpentier AC. Selective Impairment of Glucose but Not Fatty Acid or Oxidative Metabolism in Brown Adipose Tissue of Subjects With Type 2 Diabetes. Diabetes. 2015 Jul;64(7):2388-97. doi: 10.2337/db14-1651. Epub 2015 Feb 12.

    PubMed 25677914
  • Lee P, Smith S, Linderman J, Courville AB, Brychta RJ, Dieckmann W, Werner CD, Chen KY, Celi FS. Temperature-acclimated brown adipose tissue modulates insulin sensitivity in humans. Diabetes. 2014 Nov;63(11):3686-98. doi: 10.2337/db14-0513. Epub 2014 Jun 22.

    PubMed 24954193
  • Ong FJ, Ahmed BA, Oreskovich SM, Blondin DP, Haq T, Konyer NB, Noseworthy MD, Haman F, Carpentier AC, Morrison KM, Steinberg GR. Recent advances in the detection of brown adipose tissue in adult humans: a review. Clin Sci (Lond). 2018 May 25;132(10):1039-1054. doi: 10.1042/CS20170276. Print 2018 May 31.

    PubMed 29802209
  • Beiroa D, Imbernon M, Gallego R, Senra A, Herranz D, Villarroya F, Serrano M, Ferno J, Salvador J, Escalada J, Dieguez C, Lopez M, Fruhbeck G, Nogueiras R. GLP-1 agonism stimulates brown adipose tissue thermogenesis and browning through hypothalamic AMPK. Diabetes. 2014 Oct;63(10):3346-58. doi: 10.2337/db14-0302. Epub 2014 Jun 10.

    PubMed 24917578
  • Lee SJ, Sanchez-Watts G, Krieger JP, Pignalosa A, Norell PN, Cortella A, Pettersen KG, Vrdoljak D, Hayes MR, Kanoski SE, Langhans W, Watts AG. Loss of dorsomedial hypothalamic GLP-1 signaling reduces BAT thermogenesis and increases adiposity. Mol Metab. 2018 May;11:33-46. doi: 10.1016/j.molmet.2018.03.008. Epub 2018 Mar 21.

    PubMed 29650350
  • Lockie SH, Heppner KM, Chaudhary N, Chabenne JR, Morgan DA, Veyrat-Durebex C, Ananthakrishnan G, Rohner-Jeanrenaud F, Drucker DJ, DiMarchi R, Rahmouni K, Oldfield BJ, Tschop MH, Perez-Tilve D. Direct control of brown adipose tissue thermogenesis by central nervous system glucagon-like peptide-1 receptor signaling. Diabetes. 2012 Nov;61(11):2753-62. doi: 10.2337/db11-1556. Epub 2012 Aug 28.

    PubMed 22933116
  • Oliveira FCB, Bauer EJ, Ribeiro CM, Pereira SA, Beserra BTS, Wajner SM, Maia AL, Neves FAR, Coelho MS, Amato AA. Liraglutide Activates Type 2 Deiodinase and Enhances beta3-Adrenergic-Induced Thermogenesis in Mouse Adipose Tissue. Front Endocrinol (Lausanne). 2022 Jan 4;12:803363. doi: 10.3389/fendo.2021.803363. eCollection 2021.

    PubMed 35069450
  • Krieger JP, Santos da Conceicao EP, Sanchez-Watts G, Arnold M, Pettersen KG, Mohammed M, Modica S, Lossel P, Morrison SF, Madden CJ, Watts AG, Langhans W, Lee SJ. Glucagon-like peptide-1 regulates brown adipose tissue thermogenesis via the gut-brain axis in rats. Am J Physiol Regul Integr Comp Physiol. 2018 Oct 1;315(4):R708-R720. doi: 10.1152/ajpregu.00068.2018. Epub 2018 May 30.

    PubMed 29847161
  • Harder H, Nielsen L, Tu DT, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1915-21. doi: 10.2337/diacare.27.8.1915.

    PubMed 15277417
  • van Eyk HJ, Paiman EHM, Bizino MB, IJzermans SL, Kleiburg F, Boers TGW, Rappel EJ, Burakiewicz J, Kan HE, Smit JWA, Lamb HJ, Jazet IM, Rensen PCN. Liraglutide decreases energy expenditure and does not affect the fat fraction of supraclavicular brown adipose tissue in patients with type 2 diabetes. Nutr Metab Cardiovasc Dis. 2020 Apr 12;30(4):616-624. doi: 10.1016/j.numecd.2019.12.005. Epub 2019 Dec 13.

    PubMed 32127340
  • Horowitz M, Flint A, Jones KL, Hindsberger C, Rasmussen MF, Kapitza C, Doran S, Jax T, Zdravkovic M, Chapman IM. Effect of the once-daily human GLP-1 analogue liraglutide on appetite, energy intake, energy expenditure and gastric emptying in type 2 diabetes. Diabetes Res Clin Pract. 2012 Aug;97(2):258-66. doi: 10.1016/j.diabres.2012.02.016. Epub 2012 Mar 24.

    PubMed 22446097
  • Bradley DP, Kulstad R, Racine N, Shenker Y, Meredith M, Schoeller DA. Alterations in energy balance following exenatide administration. Appl Physiol Nutr Metab. 2012 Oct;37(5):893-9. doi: 10.1139/h2012-068. Epub 2012 Jun 26.

    PubMed 22735035

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Preethi Srikanthan, MD (310-825-7922, psrikanthan@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in supraclavicular temperature with cold exposure (time frame: 20weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05419726, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.

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