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Trial record 2 of 32 for:    Recruiting, Not yet recruiting, Available Studies | obesity | stimulation

Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity

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ClinicalTrials.gov Identifier: NCT03261531
Recruitment Status : Recruiting
First Posted : August 25, 2017
Last Update Posted : January 7, 2019
Sponsor:
Collaborator:
Elira Therapeutics, Inc.
Information provided by (Responsible Party):
Michael Camilleri, MD, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Obesity Device: Transcutaneous electrical nerve stimulation (TENS) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Transcutaneous electrical nerve stimulation (TENS)
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)
Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.




Primary Outcome Measures :
  1. Change in body weight [ Time Frame: Baseline, 3 months ]
    Change in body weight will be measured in kilograms or pounds

  2. Gastric half-emptying time (GE T 1/2) [ Time Frame: After 1 day treatment (approximately at 4 hours) ]
    The time for half of the ingested solids to leave the stomach

  3. Gastric half-emptying time (GE T 1/2) [ Time Frame: At 3 months, approximately 2 hours after radiolabeled meal is ingested ]
    The time for half of the ingested solids to leave the stomach


Secondary Outcome Measures :
  1. Fasting gastric volume by 99mTc-SPECT Imaging [ Time Frame: At 3 months, approx 20 minutes after 99mTC injection ]
    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.

  2. Postprandial gastric volume (gastric accommodation) by 99mTc-SPECT Imaging [ Time Frame: At 3 months, approximately 30 min after liquid meal ]
    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.

  3. Change in Gastric Emptying Percentage [ Time Frame: Day 1, 3 months ]
    The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.

  4. Satiation volume (level 3) [ Time Frame: Approximately 30 minutes after the liquid meal ]
    Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.

  5. Satiation maximum tolerated volume (level 5) [ Time Frame: Approximately 30 minutes after the liquid meal ]
    Subjects will ingest a liquid nutrient drink at a rate of 120 mL every 4 minutes; the volume ingested at each level of fullness will be recorded. Participants record their sensations of fullness using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal ("volume to fullness"), and level 5 corresponding to the maximum tolerated volume (MTV). Nutrient intake is stopped when subjects reach the score of 5.

  6. Mean Kcal Intake at Buffet Meal as a Measure of Appetite [ Time Frame: At 3 months, approximately 30 minutes after the buffet meal ]
    Assessment of kcal intake as a measure of appetite buffet meal to measure total caloric intake. 5 hours after ingesting 300 mL liquid nutrient as part of the gastric volume study, participants will be invited to eat, during a 30-minute period, a standard "free feeding" meal. The total amount of food consumed will be analyzed by the study dietitian.

  7. Change in Appetite Score [ Time Frame: Baseline, 3 months ]
    Ratings of appetite will be measured every 30 minutes between the time of ingestion of standard liquid breakfast and the start of the ad libitum meal. The appetite rating will be measured by 4- 100 mm long Visual Analog Scales (VAS). The VAS does not have any pre-set marks between the extremes of 0 for negative rating and 100 mm for positive rating. The investigator measures the mark made by the participant in mm and records this for the value. The overall appetite score will be calculated as the average of the four individual scores (satiety + fullness+100-prospective food consumption + hunger/4.

  8. Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 months [ Time Frame: baseline, 90 minutes postprandially ]
    Total ghrelin will be measured by a radioimmunoassay technique.

  9. Change in fasting and peak postprandial Glucagon-like peptide-1 (GLP-1) at 3 months [ Time Frame: baseline, 90 minutes postprandially ]
    Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.

  10. Change in fasting and peak postprandial Peptide Tyrosine Tyrosine (PYY) at 3 months [ Time Frame: baseline, 90 minutes postprandially ]
    Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261531


Contacts
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Contact: Deb Eckert, R.N 507-538-5860 eckert.deb@mayo.edu
Contact: Kayla Arndt 507-538-6599 arndt.kayla@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Deb Eckert    507-538-5860    eckert.deborah@mayo.edu   
Contact: Kayla Arndt    507-538-6599    arndt.kayla@mayo.edu   
Principal Investigator: Michael Camilleri, M.D.         
Sub-Investigator: Andres Acosta, M.D         
Sub-Investigator: Hoda Kadouh, Ph.D         
Sponsors and Collaborators
Mayo Clinic
Elira Therapeutics, Inc.
Investigators
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Principal Investigator: Michael Camilleri, M.D Mayo Clinic

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Responsible Party: Michael Camilleri, MD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03261531     History of Changes
Other Study ID Numbers: 16-001916
First Posted: August 25, 2017    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael Camilleri, MD, Mayo Clinic:
Overweight
Class I Obesity
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms