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

Type2 Diabetes Clinical Trial

— GA-7  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03702660
• Other study ID #: GA-7
• Status: Completed
• Phase: N/A
• Start date: August 1, 2017
• Est. completion date: January 23, 2018

Study information

• Verified date: April 2021
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 23, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Other:
• GIP(3-30)NH2
Peptide derived from the naturally occuring gut hormone GIP
• Peripheral venous cannulation
Intravenous access for infusions
• GLP-1
Peptide infusion

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research, Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucagon	Plasma levels of glucagon after a meal in patients with type 2-diabetes	8 weeks - 6 months