Trial Outcomes & Findings for Gastrointestinal Symptoms in Postural Orthostatic Tachycardia Syndrome (NCT NCT03263819)
NCT ID: NCT03263819
Last Updated: 2024-07-08
Results Overview
The plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose. C peptide measured in pg/ml
Recruitment status
COMPLETED
Target enrollment
26 participants
Primary outcome timeframe
0-120 minutes during intervention
Results posted on
2024-07-08
Participant Flow
The study started June 20, 2017. Participants were enrolled in Vanderbilt University medical center
We enrolled 26 subjects: * 25 subjects completed the study. * 1 subject was excluded from analysis because she was using GLP-1 agonist for weight control
Participant milestones
| Measure |
POTS Subjects
Participants with postural orthostatic tachycardia syndrome diagnosis. Oral glucose tolerance test: 75 grams of glucose
|
Healthy Controls
Healthy subjects Oral glucose tolerance test: 75 grams of glucose
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
POTS Subjects
Participants with postural orthostatic tachycardia syndrome diagnosis. Oral glucose tolerance test: 75 grams of glucose
|
Healthy Controls
Healthy subjects Oral glucose tolerance test: 75 grams of glucose
|
|---|---|---|
|
Overall Study
1 subject was excluded from analysis because she was using GLP-1 agonist for weight contro
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
POTS
n=12 Participants
Patients with postural orthostatic tachycardia syndrome diagnosis.
Oral glucose tolerance test: 75 grams of glucose
|
Healthy Controls
n=13 Participants
Healthy Subjects Oral glucose tolerance test: 75 grams of glucose
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
25 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=25 Participants
|
|
Age, Continuous
|
36.8 years
STANDARD_DEVIATION 11.7 • n=12 Participants
|
29.9 years
STANDARD_DEVIATION 7.8 • n=13 Participants
|
33.3 years
STANDARD_DEVIATION 9.7 • n=25 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=12 Participants
|
13 Participants
n=13 Participants
|
25 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=12 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
168.4 cm
STANDARD_DEVIATION 5.8 • n=12 Participants
|
168.5 cm
STANDARD_DEVIATION 5.3 • n=13 Participants
|
168.4 cm
STANDARD_DEVIATION 5.5 • n=25 Participants
|
|
BMI
|
23.4 kg/m^2
STANDARD_DEVIATION 4.1 • n=12 Participants
|
22.5 kg/m^2
STANDARD_DEVIATION 3.2 • n=13 Participants
|
22.9 kg/m^2
STANDARD_DEVIATION 3.6 • n=25 Participants
|
|
Fasting Glucose
|
90.2 mg/dl
STANDARD_DEVIATION 21.2 • n=12 Participants
|
80.4 mg/dl
STANDARD_DEVIATION 12.6 • n=13 Participants
|
85.3 mg/dl
STANDARD_DEVIATION 16.9 • n=25 Participants
|
|
Insulin
|
8.4 mlU/ml
STANDARD_DEVIATION 2.8 • n=12 Participants
|
7.5 mlU/ml
STANDARD_DEVIATION 3.8 • n=13 Participants
|
7.95 mlU/ml
STANDARD_DEVIATION 3.3 • n=25 Participants
|
|
Hematocrit
|
38.3 Percentage of RBC mass to original blood
STANDARD_DEVIATION 2.8 • n=12 Participants
|
35.9 Percentage of RBC mass to original blood
STANDARD_DEVIATION 2.2 • n=13 Participants
|
37.1 Percentage of RBC mass to original blood
STANDARD_DEVIATION 2.5 • n=25 Participants
|
|
Hemoglobin
|
12.9 mg/dl
STANDARD_DEVIATION 1.2 • n=12 Participants
|
12.1 mg/dl
STANDARD_DEVIATION 0.8 • n=13 Participants
|
12.5 mg/dl
STANDARD_DEVIATION 1.0 • n=25 Participants
|
|
AST
|
22.6 unit/L
STANDARD_DEVIATION 7.6 • n=12 Participants
|
20.2 unit/L
STANDARD_DEVIATION 5.3 • n=13 Participants
|
21.4 unit/L
STANDARD_DEVIATION 6.4 • n=25 Participants
|
|
ALT
|
16.1 unit/L
STANDARD_DEVIATION 5.4 • n=12 Participants
|
15.3 unit/L
STANDARD_DEVIATION 9.7 • n=13 Participants
|
15.7 unit/L
STANDARD_DEVIATION 7.55 • n=25 Participants
|
|
Total Bilirubin
|
0.5 mg/dl
STANDARD_DEVIATION 0.2 • n=12 Participants
|
0.7 mg/dl
STANDARD_DEVIATION 0.5 • n=13 Participants
|
0.6 mg/dl
STANDARD_DEVIATION 0.35 • n=25 Participants
|
PRIMARY outcome
Timeframe: 0-120 minutes during interventionThe plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose. C peptide measured in pg/ml
Outcome measures
| Measure |
C Peptide Level in POTS Patients
n=12 Participants
Participants with postural orthostatic tachycardia syndrome diagnosis. C peptide level after ingesting 75 grams of glucose at 120 mins
|
C Peptide Level in Healthy Controls
n=13 Participants
Healthy subjects C peptide level after ingesting 75 grams of glucose at 120 mins
|
|---|---|---|
|
C-peptide Levels After Oral Glucose Tolerance Test
|
40.6 pg/mL
Standard Deviation 9.5
|
23.2 pg/mL
Standard Deviation 4.8
|
PRIMARY outcome
Timeframe: 0-120 minutes during interventionThe plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.
Outcome measures
| Measure |
C Peptide Level in POTS Patients
n=12 Participants
Participants with postural orthostatic tachycardia syndrome diagnosis. C peptide level after ingesting 75 grams of glucose at 120 mins
|
C Peptide Level in Healthy Controls
n=13 Participants
Healthy subjects C peptide level after ingesting 75 grams of glucose at 120 mins
|
|---|---|---|
|
Insulin Levels After Oral Glucose Tolerance Test
|
85.2 uU/mL
Standard Deviation 44.0
|
48.79 uU/mL
Standard Deviation 13.69
|
PRIMARY outcome
Timeframe: 0-120 minutes after the oral glucose ingestionThe plasma levels of GIP (Glucose-dependent insulinotropic polypeptide) ,GLP-1, C-peptide, insulin) and their pattern of secretion after ingestion of 75 g glucose.
Outcome measures
| Measure |
C Peptide Level in POTS Patients
n=12 Participants
Participants with postural orthostatic tachycardia syndrome diagnosis. C peptide level after ingesting 75 grams of glucose at 120 mins
|
C Peptide Level in Healthy Controls
n=13 Participants
Healthy subjects C peptide level after ingesting 75 grams of glucose at 120 mins
|
|---|---|---|
|
GIP and GLP-1 Levels After Oral Glucose Tolerance Test
GIP secretion at 120 mins
|
75.72 pmol/L
Standard Deviation 41.77
|
42.74 pmol/L
Standard Deviation 9.6
|
|
GIP and GLP-1 Levels After Oral Glucose Tolerance Test
GLP-1 secretion at 30 mins
|
66.0 pmol/L
Standard Deviation 23.0
|
53.9 pmol/L
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: 0-120 minsThe percent change (before-after 75 gram of oral glucose) of standing heart rate and stroke volume (SV).
Outcome measures
| Measure |
C Peptide Level in POTS Patients
n=12 Participants
Participants with postural orthostatic tachycardia syndrome diagnosis. C peptide level after ingesting 75 grams of glucose at 120 mins
|
C Peptide Level in Healthy Controls
n=13 Participants
Healthy subjects C peptide level after ingesting 75 grams of glucose at 120 mins
|
|---|---|---|
|
Changes in Systemic Hemodynamics After 75-gr Oral Glucose and During Orthostasis
% change in standing HR
|
21.2 Percent change
Standard Deviation 11.9
|
6.0 Percent change
Standard Deviation 19.9
|
|
Changes in Systemic Hemodynamics After 75-gr Oral Glucose and During Orthostasis
percent change in standing stroke volume
|
-10.3 Percent change
Standard Deviation 11.90
|
3.3 Percent change
Standard Deviation 13.7
|
Adverse Events
POTS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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