| Trial ID: | L7090 |
| Source ID: | NCT05071898
|
| Associated Drug: |
Semaglutide Pen Injector [Ozempic]
|
| Title: |
Pharmacogenetics of Response to GLP1R Agonists
|
| Acronym: |
PORT
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Diabetes Type 2
|
| Interventions: |
DRUG: Semaglutide Pen Injector [Ozempic]
|
| Outcome Measures: |
Primary: First phase insulin secretion, Area under the curve for plasma insulin levels measured at times between 0-10 min after administration of intravenous glucose (0.3 g/kg), Measured both at baseline and after completing 6 weeks of semaglutide therapy|Second phase insulin secretion, Area under the curve for plasma insulin levels measured at times between 10-50 min after administration of intravenous glucose (0.3 g/kg), Measured both at baseline and after completing 6 weeks of semaglutide therapy|Rate of glucose disappearance, Slope of the plot of log(glucose concentration) as a function of time. This will be calculated based on a linear regression using data points between 25-50 minutes after administration of intravenous glucose (0.3 g/kg), Measured both at baseline and after completing 6 weeks of semaglutide therapy | Secondary: Weight loss, This will be measured as the baseline weight in kg minus the weight after completing 6 weeks of semaglutide therapy., Assessed after completing 6 weeks of semaglutide therapy | Other: Insulin sensitivity (Si), Estimated using Bergman's minimal model, Measured both at baseline and after completing 6 weeks of semaglutide therapy|Glucose effectiveness (Sg), Estimated using Bergman's minimal model, Measured both at baseline and after completing 6 weeks of semaglutide therapy
|
| Sponsor/Collaborators: |
Sponsor: University of Maryland, Baltimore
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
600
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2022-04-11
|
| Completion Date: |
2027-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-06-21
|
| Locations: |
Amish Research Clinic, Lancaster, Pennsylvania, 17602, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05071898
|
