Trial Outcomes & Findings for Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity (NCT NCT03261531)
NCT ID: NCT03261531
Last Updated: 2020-02-05
Results Overview
Change in body weight will be measured in kilograms or pounds
TERMINATED
NA
7 participants
Baseline, 3 months
2020-02-05
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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7
|
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Overall Study
COMPLETED
|
3
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Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Withdrawal by Subject
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4
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Baseline Characteristics
Dermatome Electrical Stimulation on Individuals With Overweight and Class I Obesity
Baseline characteristics by cohort
| Measure |
Transcutaneous Electrical Nerve Stimulation (TENS)
n=7 Participants
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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|---|---|
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Age, Continuous
|
46 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
|
Sex: Female, Male
Female
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3 Participants
n=99 Participants
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Sex: Female, Male
Male
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4 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
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6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
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1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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7 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 monthsPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
Change in body weight will be measured in kilograms or pounds
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: After 1 day treatment (approximately at 4 hours)Population: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
The time for half of the ingested solids to leave the stomach
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: At 3 months, approximately 2 hours after radiolabeled meal is ingestedPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
The time for half of the ingested solids to leave the stomach
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 3 months, approx 20 minutes after 99mTC injectionPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 3 months, approximately 30 min after liquid mealPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1, 3 monthsPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
The time for gastric retention of ingested solids or liquid to leave the stomach, measured in percentage.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 30 minutes after the liquid mealPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 30 minutes after the liquid mealPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 3 months, approximately 30 minutes after the buffet mealPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 monthsPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 90 minutes postprandiallyPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
Total ghrelin will be measured by a radioimmunoassay technique.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 90 minutes postprandiallyPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
Glucagon-like peptide-1 (GLP-1) will be measured by a radioimmunoassay technique.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 90 minutes postprandiallyPopulation: Study was terminated due to device failure. Sincere efforts were made but we were unable to collect data
Peptide Tyrosine Tyrosine (PYY) will be measured by radioimmunoassay.
Outcome measures
Outcome data not reported
Adverse Events
Transcutaneous Electrical Nerve Stimulation (TENS)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place