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

NCT05419726 | Recruiting FDA Drug

• 1 other identifier: 22-000718
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (3)

• change in supraclavicular temperature with cold exposure

  delta temperature

  20weeks

• change in caloric intake

  caloric intake

  20weeks

• basal metabolic rate

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

  20 weeks

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Health

Los Angeles, California, 90095, United States

RECRUITING

Related Publications (20)

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MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Preethi Srikanthan, MD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Preethi Srikanthan, MD

CONTACT

310-825-7922; psrikanthan@mednet.ucla.edu

Julie Sorg, MSN

CONTACT

310-206-2235; jsorg@mednet.ucla.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: February 1, 2023
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)