Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03261531
• Other study ID #: 16-001916
• Status: Terminated
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: January 2020
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Elira Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Body Weight	Change in body weight will be measured in kilograms or pounds	Baseline, 3 months
Primary	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)
Primary	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	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.	At 3 months, approx 20 minutes after 99mTC injection
Secondary	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.	At 3 months, approximately 30 min after liquid meal
Secondary	Change in Gastric Emptying Percentage	The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.	Day 1, 3 months
Secondary	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.	Approximately 30 minutes after the liquid meal
Secondary	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.	Approximately 30 minutes after the liquid meal
Secondary	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.	At 3 months, approximately 30 minutes after the buffet meal
Secondary	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.	Baseline, 3 months
Secondary	Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months	Total ghrelin will be measured by a radioimmunoassay technique.	baseline, 90 minutes postprandially
Secondary	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.	baseline, 90 minutes postprandially
Secondary	Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months	Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.	baseline, 90 minutes postprandially

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