Actively Recruiting
Brown Adipose Tissue Activation by Spinal Cord Stimulation for Weight Loss and Type 2 Diabetes
Led by Oregon Health and Science University · Updated on 2024-04-03
10
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether spinal cord stimulation (SCS) can activate brown adipose tissue (BAT) metabolism to support weight loss and potentially ease Type 2 diabetes. This study focuses on adults aged 21 to 70 years with persistent neuropathic leg and back pain who are planning to undergo SCS for pain control. The research aims to provide proof-of-concept evidence for a new treatment approach targeting morbid obesity and diabetes. Participants will have a second research electrode placed in the epidural space near the upper thoracic spine during their SCS trial implant procedure. Each participant will undergo two PET/CT scans on days 3 and 5 after electrode implantation: one scan at baseline without SCS activation and one with SCS activated, in randomized order. The scans will assess BAT metabolism using a special marker and imaging technique. During the study, participants will be monitored through these PET/CT scans to measure BAT activation levels. Researchers will evaluate the maximum standardized uptake value (SUVmax) and compare BAT activity on both sides of the body during SCS activation. The study includes safety monitoring and ends approximately one week after electrode implantation. Data collected will help understand how SCS influences metabolism related to weight loss and diabetes.
CONDITIONS
Brief Title
Brown Adipose Tissue Activation by Spinal Cord Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 21 and 70 years
- Persistent neuropathic leg and back pain
- Planning to undergo spinal cord stimulation for pain
- No prior spinal cord stimulation trial for pain
- Body mass index (BMI) between 25 and 45 calculated by weight and height
You will not qualify if you...
- Not considering spinal cord stimulation for pain
- Forensic patient status
- Taking beta blockers
- Weight change greater than 5% in the last 3 months
- Habitual tobacco use
- Habitual excessive alcohol use
- Pregnancy
- Decisionally impaired adults
- Children and neonates
- BMI less than 25 or greater than 45
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Day of implantation
Participants have two electrodes placed percutaneously in the epidural space at the time of spinal cord stimulation (SCS) trial implant as part of the research procedure.
1 implantation visit (in-person)
Duration - 5 days
Participants undergo two PET/CT scans on days 3 and 5 after electrode implantation to assess brown adipose tissue activation with and without SCS activation.
2 imaging visits (in-person)
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
K
Kim Burchiel, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here