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Dextrose

Phase 2

Diseases, Metabolic | Small molecule | Metabolic |Baxter International Inc.|Last Updated: Dec 31, 2014

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

Dextrose · 1 trial · 2 indications

Phase 2 1
NCT02185729Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy VolunteersDiseases, Metabolic
COMPLETED12 Analytics
PHASE2COMPLETED
Comparing Soybean Oil-Based (Intralipid) With an Olive Oil-Based (ClinOleic) Lipid Emulsion on Healthy Volunteers
Diseases, MetabolicUnlock trial analytics

Study Endpoints

Primary Endpoints

Flow Mediated Dilation
Baseline

Endothelium-dependent brachial artery flow-mediated dilation (FMD) was assessed. Ultrasound images of the brachial artery were obtained and arterial diameters were measured with customized software. Brachial artery FMD was calculated as (hyperemic diameter - baseline diameter)/baseline diameter × 100.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Healthy VolunteerACTIVE_COMPARATORSubjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)

Interventions

NameTypeDescription
IntralipidDRUGInfusion of Intralipid (soybean-derived fat)
ClinOleicDRUGInfusion of ClinOleic (olive oil-based)
DextroseDRUGInfusion of dextrose (sugar) without fat
Saline (control)OTHERInfusion of 0.9% normal saline
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or females, BMI 25 - 35 kg/m2, between the ages of 18 and 65 years Exclusion Criteria: * The patient is pregnant or breast feeding * Subjects have or with history of diabetes, hypertension, fasting triglyceride levels \> 250 mg/dL, liver disease (ALT 2.5x \> up...

Countries:United States
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