Type2 Diabetes
Conditions
Brief summary
This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.
Detailed description
A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.
Interventions
OTHERPlacebo
Saline infusion
Used for infusion on study days
DRUGDPP-4 inhibitor
Oral administration of DPP-4 inhibitor in active treatment period
OTHERPlacebo tablet
Oral administration of placebo tablet in placebo treatment period
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Double blinded study. Both participants and investigators are blinded to interventions.
Intervention model description
Randomized, placebo-controlled, cross-over.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes, treatment: lifestyle changes or metformin * HbA1c \< 75 mmol/mol
Exclusion criteria
* diagnosed liver disease * eGFR \< 60 ml/min/1,73m2 * NYHA III or IV * anemia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-peptide | 5 hours | Concentrations of C-peptide during GIP receptor antagonism compared to placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total and intact GIP | 5 hours | Concentrations of total and intact GIP during GIP receptor antagonism compared to placebo |
| Glucagon | 5 hours | Concentrations of glucagon during GIP receptor antagonism compared to placebo |
| CTX | 5 hours | Concentrations of CTX during GIP receptor antagonism compared to placebo |
| Lipids | 5 hours | Concentrations of lipids during GIP receptor antagonism compared to placebo |
| Plasma glucose | 5 hours | Concentrations of plasma glucose during GIP receptor antagonism compared to placebo |
| Insulin | 5 hours | Concentrations of insulin during GIP receptor antagonism compared to placebo |
| Total and intact GLP-1 | 5 hours | Concentrations of total and intact GLP-1 during GIP receptor antagonism compared to placebo |
Other
| Measure | Time frame | Description |
|---|---|---|
| heart rate | 5 hours | Repeated measures |
| Gallbladder volume | 5 hours | Measures from ultrasound sonography |
| Systolic and diastolic blood pressure | 5 hours | Repeated measures |
Countries
Denmark
Outcome results
None listed