Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity

Mayo Clinic7 enrolled

Overview

Investigators are doing this research study to find out the effect of T6 dermatomal electrical stimulation (delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit) on appetite and weight loss.

Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a Transcutaneous Electrical Nerve Stimulation (TENS) unit. Participants will receive 15-minute T6 dermatome cutaneous stimulation with TENS unit applied immediately before ingestion of two of main meals of the day (breakfast and evening meal), and 60 minute stimulation applied immediately after ingestion of these meals. Participants will apply the stimulus four times daily for a treatment period of at least 3 months. Participants will keep a diary of weight once weekly and a weekly appetite record.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Obesity

Interventions

Transcutaneous electrical nerve stimulation (TENS)DEVICE

Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Overweight and obese adults (BMI ≥25 kg/m2 and ≤34.99 kg/m2) residing within 125 miles of Mayo Clinic in Rochester, Minnesota; these will be otherwise healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia on diet) disorders. * Age: 18-65 years * Gender: Men or women. Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure. * Subjects must have the ability to provide informed consent before any trial-related activities. Eligible individuals will be asked to avoid taking additional medications and supplements for the duration of the study, unless reviewed and approved by the study team. Exclusion Criteria: * Abdominal surgery other than appendectomy, Caesarian section or tubal ligation * Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., Orlistat * Positive history of diabetes mellitus or use of hypoglycemic medications * Positive history of spinal cord injury and/or chronic back pain * Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD) (12), a self-administered alcoholism screening test (AUDIT-C) (13), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia) (14). If such a dysfunction is identified by a HAD score \>11 or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. * Intake of medication, whether prescribed or over the counter (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxine replacement therapy, low dose analgesia or anti-inflammatory medications (Acetaminophen and Ibuprofen) and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying and gastric accommodation. * Subjects may also be excluded from participation for other factors at the discretion of the principal investigator.

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Change in Body Weight

Change in body weight will be measured in kilograms or pounds

Time frame: Baseline, 3 months

Gastric Half-emptying Time (GE T 1/2)

The time for half of the ingested solids to leave the stomach

Time frame: After 1 day treatment (approximately at 4 hours)

Gastric Half-emptying Time (GE T 1/2)

The time for half of the ingested solids to leave the stomach

Time frame: At 3 months, approximately 2 hours after radiolabeled meal is ingested

Secondary Outcomes

Fasting Gastric Volume by 99mTc-SPECT Imaging

A noninvasive SPECT method will be used to measure gastric volume. Subjects will report to the clinic after an overnight fast. The first fasting scan will be obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.

Time frame: At 3 months, approx 20 minutes after 99mTC injection

Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging

A noninvasive SPECT method will be used to measure gastric volume after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC will be given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication (99mTc) will be given subcutaneously. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans will be obtained. Each scan requires about 9-12 min. Tomographic images of the gastric wall will be obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content. Volume will be measured in mL.

Data from ClinicalTrials.gov

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