Brown Adipose Tissue Activation by Spinal Cord Stimulation

RECRUITING

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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.

Conditions:

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

🗓️ Study Start (Actual) 19 February 2021

🗓️ Primary Completion (Estimated) October 2025

✅ Study Completion (Estimated) October 2026

👥 Enrollment (Estimated) 10

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Portland, Oregon, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 21 Years to 70 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 26 March 2020
First Submitted that Met QC Criteria 26 March 2020
First Posted 30 March 2020

Study Record Updates

Last Update Submitted that Met QC Criteria 1 April 2024
Last Update Posted 3 April 2024
Last Verified April 2024