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Device failure
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| Name | Class |
|---|---|
| Elira Therapeutics, Inc. | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Camilleri, M.D | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Body Weight | Change in body weight will be measured in kilograms or pounds | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | Baseline, 3 months |
|
|
Adverse Events were collected up to 3 months for each subject
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Camilleri, M.D. | Mayo Clinic | 507-284-2687 | camilleri.michael@mayo.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2017 | Jan 14, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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. | 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. | 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. | 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. | 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. | 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. | Baseline, 3 months |
| Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months | Total ghrelin will be measured by a radioimmunoassay technique. | 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. | 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. | baseline, 90 minutes postprandially |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
|
| Primary | Gastric Half-emptying Time (GE T 1/2) | The time for half of the ingested solids to leave the stomach | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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 | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | Baseline, 3 months |
|
|
| Secondary | Change in Fasting and Peak Postprandial Plasma Ghrelin at 3 Months | Total ghrelin will be measured by a radioimmunoassay technique. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | 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. | Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data | Posted | baseline, 90 minutes postprandially |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000698 |
| Analgesia |
| D000760 | Anesthesia and Analgesia |