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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All subjects | Experimental | All subjects will have two PET/CT scans on days 3 and 5 after SCS electrode implantation: (1) Baseline and (2) SCS-activated. Other than SCS activation, both studies will be conducted under identical conditions. For the first scan, subjects will be randomly assigned to either a baseline (no SCS during PET/CT) or with SCS during PET/CT prior to the day of their first scan. The second scan will complete the sequence with either a baseline or SCS-activated scan, as randomized. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research electrode | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| SUVmax | Maximum standardized uptake value (SUVmax) of bilateral cervical and supraclavicular regions during SCS activation, in comparison to baseline imaging | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kim Burchiel, MD | Contact | 503-494-4314 | burchiek@ohsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kim Burchiel, MD | Oregon Health and Science University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health & Science University | Recruiting | Portland | Oregon | 97239 | United States |
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| ID | Term |
|---|---|
| D001416 | Back Pain |
| D009767 | Obesity, Morbid |
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |