ObesityNCT03261531
Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Obesity, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Transcutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2017to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Transcutaneous electrical nerve stimulation (TENS)
- Keywords
- Overweight, Class I Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Transcutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Change in body weight will be measured in kilograms or pounds
Measured: Baseline, 3 months
Gastric Half-emptying Time (GE T 1/2)
The time for half of the ingested solids to leave the stomach
Measured: 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
Measured: At 3 months, approximately 2 hours after radiolabeled meal is ingested
Secondary outcomes (10)
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.
Measured: At 3 months, approx 20 minutes after 99mTC injection
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.
Measured: At 3 months, approximately 30 min after liquid meal
Change in Gastric Emptying Percentage
The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.
Measured: Day 1, 3 months
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.
Measured: Approximately 30 minutes after the liquid meal
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.
Measured: Approximately 30 minutes after the liquid meal
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.
Measured: At 3 months, approximately 30 minutes after the buffet meal
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.
Measured: Baseline, 3 months
Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months
Total ghrelin will be measured by a radioimmunoassay technique.
Measured: baseline, 90 minutes postprandially
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.
Measured: baseline, 90 minutes postprandially
Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months
Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.
Measured: baseline, 90 minutes postprandially
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start21 Feb 2017
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
Why it stopped: Device failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Elira Therapeutics, Inc.
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, M.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261531
- Sponsor's protocol ID
- 16-001916
- Status last verified
- Jan 2020
- First submitted
- 8 Aug 2017
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03261531
- Acronym / sponsor ID
- 16-001916
- Conditions
- Obesity
- Keywords
- Overweight, Class I Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Device failure
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Elira Therapeutics, Inc.
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Posted 5 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Experimental | Device: 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transcutaneous electrical nerve stimulation (TENS) |
Primary outcome
Change in Body Weight
Time frame: Baseline, 3 months
Change in body weight will be measured in kilograms or pounds
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
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
10 secondary outcomes
Fasting Gastric Volume by 99mTc-SPECT Imaging
Time frame: At 3 months, approx 20 minutes after 99mTC injection
Postprandial Gastric Volume (Gastric Accommodation) by 99mTc-SPECT Imaging
Time frame: At 3 months, approximately 30 min after liquid meal
Change in Gastric Emptying Percentage
Time frame: Day 1, 3 months
Satiation Volume (Level 3)
Time frame: Approximately 30 minutes after the liquid meal
Satiation Maximum Tolerated Volume (Level 5)
Time frame: Approximately 30 minutes after the liquid meal
Mean Kcal Intake at Buffet Meal as a Measure of Appetite
Time frame: At 3 months, approximately 30 minutes after the buffet meal
Change in Appetite Score
Time frame: Baseline, 3 months
Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months
Time frame: baseline, 90 minutes postprandially
Change in Fasting and Peak Postprandial Glucagon-like Peptide-1 (GLP-1) at 3 Months
Time frame: baseline, 90 minutes postprandially
Change in Fasting and Peak Postprandial Peptide Tyrosine Tyrosine (PYY) at 3 Months
Time frame: baseline, 90 minutes postprandially
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Camilleri, M.D principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous electrical nerve stimulation (TENS) in people with Obesity, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Weight (time frame: Baseline, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.