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The Effects of Neprilysin on Glucagon-like Peptide-1

The Effects of Neprilysin on Glucagon-like Peptide-1

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03717688
Acronym
NEP
Enrollment
19
Registered
2018-10-24
Start date
2018-05-17
Completion date
2019-05-14
Last updated
2019-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Heart Failure

Keywords

GLP-1, Neprilysin, DPP-4

Brief summary

In the current study we wish to investigate the effects on glucagon-like peptide-1 (GLP-1) of a neprilysin inhibitor

Detailed description

Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans is unknown. We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or place, to nine healthy men during a standardized meal and measured plasma concentrations of GLP-1

Interventions

Single dose administration of Entrestro 194 mg sacubitril / 206 mg valstartan

2 x 100mg sitagliptin as single dose.

DRUGPlacebos

No treatment

Sponsors

Nicolai Jacob Wewer Albrechtsen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The participants are on 4 study days with wash out period of minimum 2 weeks randomized to 4 intervention arms

Eligibility

Sex/Gender
MALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* men * body mass index between 20-25

Exclusion criteria

* acute diseases within the two weeks * chronic diseases * smoker * alcoholism, drug addiction or recent weight loss * blood donation within the last 3 months

Design outcomes

Primary

MeasureTime frameDescription
GLP-13 hours after treatment ( during the subsequent standardized meal)changes in plasma GLP-1 using immunological methods: intact and total GLP-1

Secondary

MeasureTime frameDescription
C-peptide3 hours after treatment ( during the subsequent standardized meal)changes in C-peptide using immunological methods
Glucagon3 hours after treatment ( during the subsequent standardized meal)Changes in Plasma glucagon concentrations using different analytical methodologies

Other

MeasureTime frameDescription
Blood glucose3 hours after treatment and during the subsequent standardized mealchanges in blood glucose using immunological methods
GIP3 hours after treatment ( during the subsequent standardized meal)changes in plasma GIP using immunological methods

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026