Obesity, Morbid, Pain, Back, Type 2 Diabetes
Conditions
Keywords
Obesity, Diabetes
Brief 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.
Detailed 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.
Interventions
DEVICEResearch electrode
An additional research 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 an additional electrode is a research-driven procedure.
Sponsors
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SUVmax | 1 week | Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ipsi- and contralateral BAT during SCS-activation | 1 week | A comparison of ipsi- and contralateral BAT during SCS-activation. PET/CT images will be reconstructed as per standard clinical routine. |
Countries
United States
Contacts
CONTACTKim Burchiel, MD
PRINCIPAL_INVESTIGATORKim Burchiel, MD
Oregon Health and Science University
Outcome results
None listed