Healthy
Conditions
Keywords
CCK infusion, Gallbladder ejection fraction, Normal volunteers
Brief summary
This is a clinical research study to establish normal values for the infusion of a synthetic form of the hormone cholecystokinin(CCK-8) for gallbladder emptying. Cholecystokinin is released from the small bowel to stimulate the pancreas and gallbladder to help digest and absorb food. Some people have gallbladder problems and need to be tested with the synthetic cholecystokinin ( Kinevac®, Bracco Diagnostics, Inc.). The aim of this study is to find out how differing amounts and intravenous infusion times of CCK-8 affect gallbladder emptying. The findings in normal subjects will be used to establish normal values that can then be compared with patients with suspected gallbladder disease.
Detailed description
This study enrolled 60 healthy volunteers from four institutions (Johns Hopkins University, Pennsylvania State University, Memorial Health University Medical Center, and Temple University. Subjects had to be healthy men or women 18-65 years old with no gastrointestinal disease as confirmed by initial screening using a modified Mayo Clinic Research Gastrointestinal Disease Screening Questionnaire, and normal results for CBC, metabolic profile, serum amylase and gallbladder ultrasonography. Women could not be enrolled if pregnant. Subjects had 3 infusion studies at least 2 days apart within 3 weeks.
Interventions
DRUGExperimental Sequence ABC
Drug will be given over 15 minutes, followed by infusion over 30 minutes, followed by infusion over 60 minutes
DRUGExperimental Sequence ACB
Drug infused over 15 minutes, followed by infusion over 60 minutes, followed by infusion over 30 minutes
DRUGExperimental Sequence BAC
Drug will be given over 30 min infusion, followed by 15 minute infusion, followed by 60 minute infusion
DRUGExperimental Sequence BCA
Drug will be given over 30 min infusion, followed by 60 minute infusion, followed by 15 minute infusion
DRUGExperimental Sequence CAB
Drug will be given over 60 min infusion, followed by 15 minute infusion, followed by 30 minute infusion
DRUGExperimental Sequence CBA
Drug will be given over 60 min infusion, followed by 30 minute infusion, followed by 15 minute infusion
Sponsors
Johns Hopkins University
Penn State University
Memorial Health University Medical Center
Temple University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females between ages 18-65 years of age with no gastrointestinal disease as screened by the Mayo Clinic GI Disease Screening Questionnaire 2. Subjects with high probability for compliance and completion of the study 3. Normal liver function tests and amylase 4. Normal ultrasound of the gallbladder
Exclusion criteria
1. Prior GI surgery, excluding appendectomy 2. Surgery within the past 3 months 3. BMI \> 35 4. Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test) 5. Cardiovascular, endocrine, renal, gastrointestinal, or other chronic disease likely to affect motility. This includes diabetes, renal insufficiency, gastroesophageal reflux disease, gastroparesis, irritable bowel syndrome, prior peptic ulcer disease. 6. GI symptoms such as heartburn, chest pain, dysphagia, abdominal pain, nausea, vomiting, constipation, diarrhea.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 15, 30, 45, and 60 minutes post drug infusion | The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values. |
Secondary
| Measure | Time frame |
|---|---|
| Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 15, 30, 45 and 60 minutes post-infusion |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants CCK-8 0.02 mg/kg over 15, 30 or 60 minutes: Drug will be given over infusions at different time periods. All participants received all treatments. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 38 years STANDARD_DEVIATION 12 |
| Gender Female | 32 Participants |
| Gender Male | 28 Participants |
| Region of Enrollment United States | 60 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method
The primary statistical endpoint was the CV as a measure of variability for the GBEF for each infusion method at the different intervals to determine which sincalide infusion method had the lowest variation. The CV is the SD divided by the mean and is expressed as a percentage and reflects the variability among the values. The infusion method having the lowest CV is considered best as it reflects the lowest variability of the values.
Time frame: 15, 30, 45, and 60 minutes post drug infusion
Population: Some participants were excluded from analyses due to location testing procedures
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 15min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 15 min post infusion | 51.66 percentage |
| 15min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 30 min post infusion | 40.46 percentage |
| 15min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 45 min post infusion | 39.91 percentage |
| 15min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 60 min post infusion | 35.21 percentage |
| 30 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 60 min post infusion | 29.11 percentage |
| 30 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 15 min post infusion | 62.75 percentage |
| 30 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 45 min post infusion | 31.30 percentage |
| 30 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 30 min post infusion | 34.49 percentage |
| 60 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 60 min post infusion | 18.55 percentage |
| 60 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 30 min post infusion | 35.81 percentage |
| 60 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 45 min post infusion | 24.00 percentage |
| 60 Min Infusion | Coefficient of Variation (CV) for Gallbladder Ejection Fraction (GBEF) for Each Infusion Method | 15 min post infusion | 71.38 percentage |
Secondary
Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method
Time frame: 15, 30, 45 and 60 minutes post-infusion
Population: Some participants were excluded from analyses due to location testing procedures
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 15min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 15 minutes post-infusion | 57 percentage | Standard Deviation 29 |
| 15min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 30 minutes post-infusion | 67 percentage | Standard Deviation 27 |
| 15min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 45 minutes post-infusion | 66 percentage | Standard Deviation 26 |
| 15min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 60 minutes post-infusion | 68 percentage | Standard Deviation 24 |
| 30 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 60 minutes post-infusion | 74 percentage | Standard Deviation 21 |
| 30 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 15 minutes post-infusion | 44 percentage | Standard Deviation 28 |
| 30 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 45 minutes post-infusion | 73 percentage | Standard Deviation 23 |
| 30 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 30 minutes post-infusion | 71 percentage | Standard Deviation 24 |
| 60 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 60 minutes post-infusion | 84 percentage | Standard Deviation 16 |
| 60 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 30 minutes post-infusion | 64 percentage | Standard Deviation 23 |
| 60 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 45 minutes post-infusion | 78 percentage | Standard Deviation 19 |
| 60 Min Infusion | Gallbladder Ejection Fraction (GBEF) as a Percent for Each Infusion Method | 15 minutes post-infusion | 34 percentage | Standard Deviation 24 |