Effect of GIP After a Meal in Patients With Type 2 Diabetes (GA-7)

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Type2 Diabetes

Treatments: Other: GLP-1; Other: GIP(3-30)NH2; Other: Peripheral venous cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03702660

GA-7

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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10 participants in 4 patient groups, including a placebo group

GIP(3-30)NH2

Experimental group

Description:

GIP receptor antagonist

Treatment:

Other: GIP(3-30)NH2

Other: Peripheral venous cannulation

Placebo

Placebo Comparator group

Description:

Placebo (saline infusions)

Treatment:

Other: Peripheral venous cannulation

GLP-1

Active Comparator group

Treatment:

Other: GLP-1

Other: Peripheral venous cannulation

GLP-1 + GIP(3-30)NH2

Experimental group

Treatment:

Other: GLP-1

Other: GIP(3-30)NH2

Other: Peripheral venous cannulation