Effect of Hyperglycemia on Microvascular Perfusion in Hea... | NCT03520569

ID	Type	Description	Link
T32DK007646	U.S. NIH Grant/Contract		View source

Effect of Hyperglycemia on Microvascular Perfusion in Hea... | NCT03520569 | Trialant

Sponsor/Collaborators Module

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Octreotide- Euglycemia	Active Comparator	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	Drug: Octreotide Drug: Insulin Drug: Dextrose 20% solution
Octreotide - Euglycemia- insulin clamp	Active Comparator	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	Drug: Octreotide Drug: Insulin Drug: Dextrose 20% solution
Octreotide- hyperglycemia	Active Comparator	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	Drug: Octreotide Drug: Insulin Drug: Dextrose 20% solution
Octreotide- hyperglycemia - insulin clamp	Active Comparator	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	Drug: Octreotide Drug: Insulin Drug: Dextrose 20% solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Octreotide	Drug	we are using it to block insulin secretion from the pancreas	Octreotide - Euglycemia- insulin clamp Octreotide- Euglycemia Octreotide- hyperglycemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Flow Mediated Dilation (FMD) Between 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 .	baseline and after 2 hour insulin clamp

Secondary Outcomes

Measure	Description	Time Frame
Change in Augmentation Index Between 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.

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia		Charlottesville	Virginia	22908	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18580168	Background	Deedwania P, Kosiborod M, Barrett E, Ceriello A, Isley W, Mazzone T, Raskin P. Hyperglycemia and acute coronary syndrome: a scientific statement from the American Heart Association Diabetes Committee of the Council on Nutrition, Physical Activity, and Metabolism. Anesthesiology. 2008 Jul;109(1):14-24. doi: 10.1097/ALN.0b013e31817dced3.
11742414	Background	Brownlee M. Biochemistry and molecular cell biology of diabetic complications. Nature. 2001 Dec 13;414(6865):813-20. doi: 10.1038/414813a.

ID	Title	Description
FG000	All Participants	All participants enrolled who completed at least one arm of the crossover assignment.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00015 subjects
Octreotide-Euglycemia		FG00013 subjects
Octreotide-Euglycemia-Insulin Clamp		FG00014 subjects
Octreotide-Hyperglycemia		FG00010 subjects
Octreotide-Hyperglycemia-Insulin Clamp		FG00012 subjects
COMPLETED		FG00014 subjects
NOT COMPLETED		FG0001 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0001 subjects

Baseline Characteristics Module

ID	Title	Description
BG000	All Participants	all participants who completed the study

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Flow Mediated Dilation (FMD) Between 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 .

Posted

Mean

Standard Deviation

% change

baseline and after 2 hour insulin clamp

ID	Title	Description
OG000	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 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
OG001

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 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

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Eugene Barrett	University of Virginia	434-924-1263		EJB8X@VIRGINIA.EDU

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 16, 2017	Oct 7, 2021	Prot_SAP_000.pdf

Condition Browse Module

ID	Term
D007333	Insulin Resistance

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Intervention Browse Module

ID	Term
D015282	Octreotide
D007328	Insulin
D005947	Glucose
D012996	Solutions

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D010455	Peptides

Secondary

Change in Augmentation Index Between 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.

Posted

Mean

Standard Deviation

percentage

baseline and after 2 hour insulin clamp

ID	Title	Description
OG000	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 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
OG001	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 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
OG002	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 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
OG003	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 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

Units	Counts
Participants	OG00013 OG00114 OG00210 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-4.15± 11.72 OG001-2.23± 12.33 OG002-4.80± 12.13 OG003

Secondary

Change in Pulse Wave Velocity (PWV) Between 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

Posted

Mean

Standard Deviation

m/sec

baseline and after 2 hour insulin clamp

ID	Title	Description
OG000	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 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
OG001	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 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
OG002	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 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
OG003	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 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

Units	Counts
Participants	OG00013 OG00114 OG00210 OG003

Title

Denominators