Brown Adipose Tissue Activation by Spinal Cord Stimulation

Type 2 Diabetes Clinical Trial

Official title:

Brown Adipose Tissue Activation by Spinal Cord Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04326192
• Other study ID #: STUDY00020197
• Status: Recruiting
• Phase: N/A
• Start date: February 19, 2021
• Est. completion date: October 2026

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: Kim Burchiel, MD
• Phone: 503-494-4314
• Email: burchiek[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to investigate and utilize spinal cord stimulation (SCS) as an effective approach to eliciting weight loss and potentially alleviating Type 2 diabetes mellitus (DM), as evidenced by increasing metabolism of adipose tissue.

Description:

This research study aims to investigate possible activation of brown adipose tissue (BAT) metabolism by upper thoracic spinal cord stimulation (SCS). We believe that our multidisciplinary research team presents a unique opportunity to test whether SCS can activate BAT metabolism, as tested during a routine screening procedure for spinal cord stimulation (SCS) for pain control. Our marker for BAT activation is 18F-fluorodeoxyglucose (FDG) - positron emission tomography (PET), which has previously been used to gauge cold-evoked BAT activation, and other studies of BAT in humans. We believe this proof-of-concept study could pave the way for a new therapeutic modality for the treatment of morbid obesity, and Type 2 Diabetes Mellitus.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Age: 21-70 years

2. Persistent neuropathic leg and back pain

3. Subjects who are already planning to undergo SCS for pain

4. Subjects who have not received a prior SCS trial for pain

5. Subjects with a BMI of 25-45, using formula; weight (lb) / [height (in)]2 x 703

Exclusion Criteria:

1. Not considering SCS for pain

2. Forensic patient

3. Taking beta blockers

4. Weight change > 5% within last 3 months

5. Habitual tobacco use

6. Habitual excessive alcohol use

7. Pregnancy

8. Decisionally impaired adults

9. Children

10. Neonates

11. Subjects with a BMI of <25 or >45

Related Conditions & MeSH terms

• Back Pain
• Obesity, Morbid
• Pain, Back
• Type 2 Diabetes

Intervention

Device:
• Research electrode
A second electrode will be placed percutaneously by Tuohy needle in the epidural space at the same time as the SCS trial implant; at lateral T1-2 area randomly assigned to the left or right side of the lateral epidural space, at the time of the procedure. Placement of electrodes is not experimental, but the placement of a second electrode is a research-driven procedure.

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVmax	Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging	1 week
Secondary	Ipsi- and contralateral BAT during SCS-activation	A comparison of ipsi- and contralateral BAT during SCS-activation. PET/CT images will be reconstructed as per standard clinical routine.	1 week