| Trial ID: | L3265 |
| Source ID: | NCT03508739
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| Associated Drug: |
Sacubitril/Valsartan 200mg (Blinded)
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| Title: |
Glucagon-like Peptide-1 Metabolism and Acute Neprilysin Inhibition
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| Acronym: |
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| Status: |
SUSPENDED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Diabetes Mellitus, Type 2|Pre-diabetic|Hypertension|Elevated Blood Pressure
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| Interventions: |
DRUG: Sacubitril/Valsartan 200mg (blinded)|DRUG: Valsartan 160mg (blinded)
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| Outcome Measures: |
Primary: Intact glucagon like peptide-1 (GLP-1) levels after the mixed meal, GLP-1 is a hormone released after a meal that has been shown to improve insulin and glucose dynamics. It is a target for diabetes therapies. We will compare GLP-1 levels during the different drug treatments and at baseline., This will be measured just before the meal and after the meal at pre-specified time points for a total of four hours. (Time points 0 to 4 hours) | Secondary: Insulin levels after the mixed meal, Insulin is a hormone released from the pancreas that helps with blood glucose control. We will measure insulin levels during the different drug treatments and at baseline., This will be measured just before the meal and after the meal at pre-specified time points for a total of four hours. (Time points 0 to 4 hours)|Blood glucose levels after the mixed meal, We will compare blood glucose levels during the different drug treatments and at baseline., This will be measured just before the meal and after the meal at pre-specified time points for a total of four hours. (Time points 0 to 4 hours)|Triglyceride levels after the mixed meal, Triglycerides are a component of a routine lipid/ cholesterol panel. They rise in the setting of increased fat intake. GLP-1 is thought to decrease triglyceride levels. We will compare triglyceride levels during the different drug treatments and at baseline., This will be measured just before the meal and after the meal at pre-specified time points for a total of four hours. (Time points 0 to 4 hours)|Neprilysin enzyme (drug) activity at baseline, during sacubitril/valsartan, and during valsartan, Neprilysin is an enzyme that breaks down several proteins, including glucagon-like peptide-1 (GLP-1). Sacubitril in sacubitril/valsartan is a pro-drug of a neprilysin inhibitor. This assay level will help to determine if the changes seen after the meal are related to alterations in this enzyme activity and administration of the drug sacubitril/valsartan compared to valsartan. We will measure this before the medication is administered (thus at baseline) and two hours after the drug is administered and just prior to the mixed meal., Time points -120 min (before drug given) and 0 min (2 hours after drug dose, just prior to the meal)
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| Sponsor/Collaborators: |
Sponsor: University of Pennsylvania
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
25
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
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| Start Date: |
2018-06-01
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| Completion Date: |
2026-06-30
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| Results First Posted: |
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| Last Update Posted: |
2024-08-15
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| Locations: |
University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
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| URL: |
https://clinicaltrials.gov/show/NCT03508739
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