Trial Outcomes & Findings for Body Surface Gastric Mapping in Patients on Semaglutide (NCT NCT06401746)
NCT ID: NCT06401746
Last Updated: 2026-08-31
Results Overview
Amplitude is a measure of the strength of contractions. It has a normative reference range between 22-70 microvolts; values outside this range indicate a worse outcome. Minimum: 0.
COMPLETED
9 participants
Baseline, Month 2 (On Drug)
2026-08-31
Participant Flow
Patients aged ≥ 18 years, did not present with gastroduodenal symptoms and prescribed semaglutide as part of their standard care (for weight loss or diabetes) were recruited from a tertiary center.
Participant milestones
| Measure |
Semaglutide
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Overall Study
STARTED
|
9
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Age, Continuous
|
55 Years
n=8 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 2 (On Drug)Amplitude is a measure of the strength of contractions. It has a normative reference range between 22-70 microvolts; values outside this range indicate a worse outcome. Minimum: 0.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.
Baseline
|
37.05 microvolts
Standard Deviation 8.14
|
|
Change in Overall BSGM BMI-adjusted Amplitude on Drug Compared to Baseline.
On Drug
|
32.94 microvolts
Standard Deviation 5.42
|
SECONDARY outcome
Timeframe: Baseline, Month 2 (On Drug)The BSGM Principal Gastric Frequency is the number of slow waves in a minute and measured as cycles per minute (cpm). It has a normative reference range between 2.65-3.35 cpm; values outside this range indicate a worse outcome. Minimum: 0; maximum: 6.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.
Baseline
|
3.00 cycles per minute (cpm)
Standard Deviation 0.10
|
|
Change in Overall BSGM Principal Gastric Frequency on Drug Compared to Baseline.
On Drug
|
3.12 cycles per minute (cpm)
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline, Month 2 (On Drug)BSGM Gastric Alimetry Rhythm Index is a measure of stability; calculated as a single unitless value. A normal value is indicated as more than or equal to 0.25; a lower value indicates greater instability/worse outcomes. Minimum: 0; maximum: 1.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.
Baseline
|
0.57 Index
Standard Deviation 0.24
|
|
Change in Overall BSGM Gastric Alimetry Rhythm Index on Drug Compared to Baseline.
On Drug
|
0.44 Index
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Baseline, Month 2 (On Drug)Fed:fasted amplitude ratio is the ratio of the maximum 1-hour averaged postprandial amplitude to the premeal average amplitude and calculated as a single value. A normal value is indicated as \>1.08; a higher value indicates a better outcome. Minimum: 0.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.
Baseline
|
2.08 Ratio
Standard Deviation 1.06
|
|
Change in Overall BSGM Fed:Fasted Amplitude Ratio on Drug Compared to Baseline.
On Drug
|
1.64 Ratio
Standard Deviation 0.58
|
SECONDARY outcome
Timeframe: Baseline, Month 2 (On Drug)Meal response ratio is the ratio of the average amplitude in the first 2 hours postprandially to that of the last 2 hours and calculated as a single value. A normal meal response ratio is defined as \> 1; a higher value indicates a better outcome. Minimum: 0.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.
Baseline
|
1.42 Ratio
Standard Deviation 0.89
|
|
Change in Overall BSGM Meal Response Ratio on Drug Compared to Baseline.
On Drug
|
1.03 Ratio
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline, 2 Months (On Drug)Minimum: 0; maximum: 70. A total symptom burden score is calculated by the sum of the mean of each symptom score. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Total Symptom Burden Score on Drug Compared to Baseline.
Baseline
|
6.25 Score on a scale
Standard Deviation 5.44
|
|
Change in Total Symptom Burden Score on Drug Compared to Baseline.
On Drug
|
3.5 Score on a scale
Standard Deviation 3.07
|
SECONDARY outcome
Timeframe: Baseline, 2 Months (On Drug)Minimum: 0; maximum: 5. The total GCSI score cover three subscales: nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), and bloating (2 items); calculated by taking the mean of the three individual subscale scores. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline.
Baseline
|
0.63 Scores on a scale
Standard Deviation 0.54
|
|
Change in Total Gastroparesis Cardinal Symptom Index (GCSI) Score on Drug Compared to Baseline.
On Drug
|
0.85 Scores on a scale
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline, 2 Months (On Drug)Minimum: 0; maximum: 5. The total PAGI-SYM score covers six subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), post-prandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items); calculated by taking the mean of the six individual subscale scores. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Total Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Score on Drug Compared to Baseline.
Baseline
|
0.70 Scores on a scale
Standard Deviation 0.68
|
|
Change in Total Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Score on Drug Compared to Baseline.
On Drug
|
0.65 Scores on a scale
Standard Deviation 0.33
|
SECONDARY outcome
Timeframe: Baseline, 2 Months (On Drug)Minimum: 0; maximum: 5. The PAGI-SYM fullness/early satiation subscale covers post-prandial fullness/early satiety (4 items); calculated by taking the mean of the 4 items. A higher score indicates a worse outcome.
Outcome measures
| Measure |
Semaglutide
n=8 Participants
Patients undergoing Body Surface Gastric Mapping before and after administration of Semaglutide.
|
|---|---|
|
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Fullness/Early Satiation Subscale on Drug Compared to Baseline.
Baseline
|
0.81 Scores on a scale
Standard Deviation 0.76
|
|
Change in Patient Assessment of Upper Gastrointestinal Symptom Severity Index (PAGI-SYM) Fullness/Early Satiation Subscale on Drug Compared to Baseline.
On Drug
|
1.72 Scores on a scale
Standard Deviation 0.54
|
Adverse Events
Semaglutide
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