The primary aim of the study is to evaluate how GIP receptor activation influence food intake and mechanisms regulating food intake in obese individuals with type 2 diabetes that are in steady treatment with metformin and a GLP-1 receptor agonist.
The study is designed as a double blinded cross-over study with two study days: One day of GIP infusion (for 5 hours) and one day with placebo (saline) infusion (for 5 hours). The primary endpoint is difference in food intake between the two study days. Food intake is examined as amount of food eaten during an ad libitum meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
22
5-hour GIP1-42 infusion (time point 0-300 minutes)
5-hour infusion of saline (placebo) (time point 0-300 minutes)
Center for diabetes research
Hellerup, Denmark
food intake
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
Time frame: time point 300-330 minutes
Appetite
Appetite rated on visual analogue scales (0-10 mm)
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
satiety
Satiety rated on visual analogue scales (0-10 mm)
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
prospective food consumption
prospective food consumption rated on visual analogue scales (0-10 mm)
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
fullness
fullness rated on visual analogue scales (0-10 mm)
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Thirst
Thirst rated on visual analogue scales (0-10 mm)
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Nausea
Nausea rated on visual analogue scales (0-10 mm)
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
Energy expenditure
resting energy expenditure measured by indirect calorimetry (kcal/day)
Time frame: measured at baseline and at time point 250 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
gastric emptying
acetaminophen test
Time frame: ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
gallbladder emptying
gallbladder emptying evaluated by ultrasound
Time frame: at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes
glucagon responses
blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Insulin responses
blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
C-peptide responses
blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
gut hormone responses
Blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
bone turnover markers
Blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes