Clinical trial NCT03261531: Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity
Official title: Effect of T6 Dermatome Electrical Stimulation on Gastric Motor Functions, Appetite, Satiation, Satiety and Weight Loss in Individuals With Overweight and Class I Obesity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Overweight
Class I Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Elira Therapeutics, Inc.
First posted: 2017-08-25
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Body Weight
timeFrame: Baseline, 3 months
measure: Gastric Half-emptying Time (GE T 1/2)
timeFrame: After 1 day treatment (approximately at 4 hours)
measure: Gastric Half-emptying Time (GE T 1/2)
timeFrame: At 3 months, approximately 2 hours after radiolabeled meal is ingested
Secondary outcomes:
measure: Fasting Gastric Volume by 99mTc-SPECT Imaging
timeFrame: At 3 months, approx 20 minutes after 99mTC injection
measure: Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging
timeFrame: At 3 months, approximately 30 min after liquid meal
measure: Change in Gastric Emptying Percentage
timeFrame: Day 1, 3 months
measure: Satiation Volume (Level 3)
timeFrame: Approximately 30 minutes after the liquid meal
measure: Satiation Maximum Tolerated Volume (Level 5)
timeFrame: Approximately 30 minutes after the liquid meal
measure: Mean Kcal Intake at Buffet Meal as a Measure of Appetite
timeFrame: At 3 months, approximately 30 minutes after the buffet meal
measure: Change in Appetite Score
timeFrame: Baseline, 3 months
measure: Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months
timeFrame: baseline, 90 minutes postprandially
measure: Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months
timeFrame: baseline, 90 minutes postprandially
measure: Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months
timeFrame: baseline, 90 minutes postprandially
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael Camilleri, M.D
role: PRINCIPAL_INVESTIGATOR
References: