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OpenTrials
Completed

NCT Number: NCT03702660

Effect of GIP After a Meal in Patients With Type 2 Diabetes

The aim of this study is to investigate the effects of antagonising GIP after a meal on plasma levels of glucagon. 10 participants are going through four experimental days each, where they ingest a meal and afterwards receive infusions of either GIP receptor antagonist, GLP-1, GIP receptor antagonist + GLP-1 or placebo (saline) in a randomised order. The primary endpoint of the study is plasma levels of glucagon, which we hypothesize will decrease with infusion of GIP receptor antagonist and/or with infusion of GLP-1.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diabetes Research, Gentofte Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Caucasians between 18-75 years with diet og Metformin treated type 2-diabetes
  • HbA1c < 75 mmol/mol
  • BMI > 27 kg/m2
  • Stable weight (+/- 5%) during the last 3 months

Exclusion criteria

  • Treatment with medicine or dietary supplements that cannot the paused for 12 hours
  • More than 14 units of alcohol weekly or abuse of drugs
  • Liver disease, estimated at plasma ALAT levels > 3 x normal value or INR outside normal range
  • Reduced kidney function (estimated at eGFR < 60 ml/min/1,73 m2)
  • Severe arteriosclerotic heart disease or heart failure (NYHA III or IV)
  • Low red blood cell count (hemoglobin < 8.3 mmol/l
  • Special diet or planned weight change during the trial period
  • Any disease/condition, which the clinical investigators assess will disturb the participation in the clinical trial

Treatment and study plan

GIP(3-30)NH2

Other

Peptide derived from the naturally occuring gut hormone GIP

Peripheral venous cannulation

Other

Intravenous access for infusions

GLP-1

Other

Peptide infusion

Primary outcomes

  1. Glucagon

    Time frame: 8 weeks - 6 months

    Plasma levels of glucagon after a meal in patients with type 2-diabetes

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Official study title

Effect of GIP-receptorantantagonist on Glucagon Plasma Levels After a Meal in Patients With Type 2-diabetes

Acronym: GA-7

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 11, 2018
Registry last updated
Apr 27, 2021

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.

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