Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity
Primary Purpose
Obesity
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcutaneous electrical nerve stimulation (TENS)
Sponsored by

About this trial
This is an interventional basic science trial for Obesity focused on measuring Overweight, Class I Obesity
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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transcutaneous electrical nerve stimulation (TENS)
Arm Description
Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)
Outcomes
Primary Outcome Measures
Change in Body Weight
Change in body weight will be measured in kilograms or pounds
Gastric Half-emptying Time (GE T 1/2)
The time for half of the ingested solids to leave the stomach
Gastric Half-emptying Time (GE T 1/2)
The time for half of the ingested solids to leave the stomach
Secondary Outcome Measures
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.
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.
Change in Gastric Emptying Percentage
The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.
Satiation Volume (Level 3)
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.
Satiation Maximum Tolerated Volume (Level 5)
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.
Mean Kcal Intake at Buffet Meal as a Measure of Appetite
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.
Change in Appetite Score
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.
Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months
Total ghrelin will be measured by a radioimmunoassay technique.
Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months
Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.
Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months
Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.
Full Information
NCT ID
NCT03261531
First Posted
August 8, 2017
Last Updated
January 14, 2020
Sponsor
Mayo Clinic
Collaborators
Elira Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03261531
Brief Title
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
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Terminated
Why Stopped
Device failure
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Elira Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Overweight, Class I Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transcutaneous electrical nerve stimulation (TENS)
Arm Type
Experimental
Arm Description
Healthy volunteers who are overweight or have class I obesity will receive T6 dermatomal electrical stimulation via Transcutaneous electrical nerve stimulation (TENS)
Intervention Type
Device
Intervention Name(s)
Transcutaneous electrical nerve stimulation (TENS)
Intervention Description
Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
Primary Outcome Measure Information:
Title
Change in Body Weight
Description
Change in body weight will be measured in kilograms or pounds
Time Frame
Baseline, 3 months
Title
Gastric Half-emptying Time (GE T 1/2)
Description
The time for half of the ingested solids to leave the stomach
Time Frame
After 1 day treatment (approximately at 4 hours)
Title
Gastric Half-emptying Time (GE T 1/2)
Description
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 Outcome Measure Information:
Title
Fasting Gastric Volume by 99mTc-SPECT Imaging
Description
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
Title
Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging
Description
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.
Time Frame
At 3 months, approximately 30 min after liquid meal
Title
Change in Gastric Emptying Percentage
Description
The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.
Time Frame
Day 1, 3 months
Title
Satiation Volume (Level 3)
Description
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.
Time Frame
Approximately 30 minutes after the liquid meal
Title
Satiation Maximum Tolerated Volume (Level 5)
Description
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.
Time Frame
Approximately 30 minutes after the liquid meal
Title
Mean Kcal Intake at Buffet Meal as a Measure of Appetite
Description
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.
Time Frame
At 3 months, approximately 30 minutes after the buffet meal
Title
Change in Appetite Score
Description
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.
Time Frame
Baseline, 3 months
Title
Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months
Description
Total ghrelin will be measured by a radioimmunoassay technique.
Time Frame
baseline, 90 minutes postprandially
Title
Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months
Description
Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.
Time Frame
baseline, 90 minutes postprandially
Title
Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months
Description
Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.
Time Frame
baseline, 90 minutes postprandially
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Camilleri, M.D
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity
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