Skip to main content
OpenTrials
Completed

NCT Number: NCT03717688

The Effects of Neprilysin on Glucagon-like Peptide-1

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Heart Failure Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

University of Copenhagen

Copenhagen, 2100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entresto

Drug

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

Other names: ARNI, Neprilysin inhibibitor

Sitagliptin 100mg

Drug

2 x 100mg sitagliptin as single dose.

Other names: DPP-4 inhibitor

Placebos

Drug

No treatment

Other names: placebo

Primary outcomes

  1. GLP-1

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

    changes in plasma GLP-1 using immunological methods: intact and total GLP-1

Secondary outcomes

  1. C-peptide

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

    changes in C-peptide using immunological methods

  2. Glucagon

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

    Changes in Plasma glucagon concentrations using different analytical methodologies

Other outcomes

  1. Blood glucose

    Time frame: 3 hours after treatment and during the subsequent standardized meal

    changes in blood glucose using immunological methods

  2. GIP

    Time frame: 3 hours after treatment ( during the subsequent standardized meal)

    changes in plasma GIP using immunological methods

Sponsors and collaborators

Lead sponsor

Nicolai Jacob Wewer Albrechtsen

Other

Registry information

Acronym: NEP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2018
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.