Trial · Interventional
CompletedEarly phase 1Results postedRegistry dataShort name EJB050
United States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The investigators are studying the effects of Hyperglycemia on vascular function and insulin sensitivity on healthy adults
Active comparator
Octreotide- Euglycemia
octreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min
Active comparator
Octreotide - Euglycemia- insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min
Active comparator
Octreotide- hyperglycemia
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Active comparator
Octreotide- hyperglycemia - insulin clamp
octreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min
Outcomes the sponsor listed as primary.
Change in Flow Mediated Dilation (FMD) Between Baseline and After 2 Hour Insulin Clamp
Time frame · baseline and after 2 hour insulin clamp
Flow mediated dilation measures the change in brachial diameter in response to 5 minutes of ischemia using B-mode ultrasound. It provides an index of nitric oxide generation by the endothelium .
Change in Augmentation Index Between Baseline and After 2 Hour Insulin Clamp
Time frame · baseline and after 2 hour insulin clamp
The augmentation index (AIx) measured at the radial artery is a measure of systemic arterial stiffness, and is defined as the ratio of augmentation (Δ P) to central pulse pressure and expressed as percent. AIx = (ΔP/PP) x 100, where P = pressure and PP = Pulse Pressure. Higher percentages indicate increased arterial stiffness.
Change in Pulse Wave Velocity (PWV) Between Baseline and After 2 Hour Insulin Clamp
Time frame · baseline and after 2 hour insulin clamp
The time required for a blood pressure wave to travel from the carotid to the femoral artery was measured in meter/sec. This is a measurement of central artery stiffness. Higher numbers indicate stiffer vessels
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (% change) | Spread |
|---|---|---|
| Octreotide- Euglycemia | 11.8 | 4.4 |
| Octreotide - Euglycemia- Insulin Clamp | 11.8 | 4 |
| Octreotide- Hyperglycemia | 8.9 | 4.3 |
| Octreotide- Hyperglycemia - Insulin Clamp | 8.95 | 4.5 |
| Group | Value (percentage) | Spread |
|---|---|---|
| Octreotide- Euglycemia | -4.15 | 11.72 |
| Octreotide - Euglycemia- Insulin Clamp | -2.23 | 12.33 |
| Octreotide- Hyperglycemia | -4.80 | 12.13 |
| Octreotide- Hyperglycemia - Insulin Clamp | -8.45 | 9.16 |
| Group | Value (m/sec) | Spread |
|---|---|---|
| Octreotide- Euglycemia | 5.21 | 0.64 |
| Octreotide - Euglycemia- Insulin Clamp | 5.06 | 0.76 |
| Octreotide- Hyperglycemia | 4.79 | 0.79 |
| Octreotide- Hyperglycemia - Insulin Clamp | 5.07 | 0.67 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Octreotide- Euglycemiaoctreotide is 30 ng/kg/min x 240 min insulin 0.15mU/kg/min x 240 min Dextrose 20% at variable rate to maintain euglycemia for 240 min Octreotide: we are using it to block insulin secretion from the pancreas Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp Dextrose 20% solution: We are using dextrose to maintain glycemia level | 0 / 13 | 0 / 13 | 0 / 13 |
| Octreotide - Euglycemia- Insulin Clampoctreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 330 min Octreotide: we are using it to block insulin secretion from the pancreas Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp Dextrose 20% solution: We are using dextrose to maintain glycemia level | 0 / 14 | 0 / 14 | 0 / 14 |
| Octreotide- Hyperglycemiaoctreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 330 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min Octreotide: we are using it to block insulin secretion from the pancreas Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp Dextrose 20% solution: We are using dextrose to maintain glycemia level | 0 / 10 | 0 / 10 | 0 / 10 |
| Octreotide- Hyperglycemia - Insulin Clampoctreotide is 30 ng/kg/min x 330 min insulin 0.15mU/kg/min x 210 min insulin 1.0mU/kg/min x 120 min Dextrose 20% at variable rate to maintain euglycemia for 90 min Dextrose 20% at variable rate to maintain hyperglycemia for 240 min Octreotide: we are using it to block insulin secretion from the pancreas Insulin: we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp Dextrose 20% solution: We are using dextrose to maintain glycemia level | 0 / 12 | 0 / 12 | 0 / 12 |
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