Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity

NCT03261531 | Terminated Results FDA Device

• 1 other identifier: 16-001916
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Overweight; Class I Obesity

Outcome Measures

Primary Outcomes (3)

• Change in Body Weight

  Change in body weight will be measured in kilograms or pounds

  Baseline, 3 months

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

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

  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

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

Secondary Outcomes (10)

• Fasting Gastric Volume by 99mTc-SPECT Imaging

  At 3 months, approx 20 minutes after 99mTC injection

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

  At 3 months, approximately 30 min after liquid meal

• Change in Gastric Emptying Percentage

  Day 1, 3 months

• Satiation Volume (Level 3)

  Approximately 30 minutes after the liquid meal

• Satiation Maximum Tolerated Volume (Level 5)

  Approximately 30 minutes after the liquid meal

Study Arms (1)

Transcutaneous electrical nerve stimulation (TENS)

EXPERIMENTAL

Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)

Device: Transcutaneous electrical nerve stimulation (TENS)

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.

Transcutaneous electrical nerve stimulation (TENS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Elira Therapeutics, Inc.: collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Michael Camilleri, M.D.
• Organization: Mayo Clinic

camilleri.michael@mayo.edu

507-284-2687

Study Officials

• Michael Camilleri, M.D

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 25, 2017
• Study Start: February 21, 2017
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: February 5, 2020
• Results First Posted: February 5, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)