Center for diabetes research
Hellerup, DK-2900, Denmark
NCT Number: NCT03526289
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.
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Notify Me18 year–70 year
Male
Interventional
Not applicable
Hellerup, DK-2900, Denmark
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
5-hour GIP1-42 infusion (time point 0-300 minutes)
5-hour infusion of saline (placebo) (time point 0-300 minutes)
Time frame: time point 300-330 minutes
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
Time frame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
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 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 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 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 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 rated on visual analogue scales (0-10 mm)
Time frame: measured at baseline and at time point 250 minutes
resting energy expenditure measured by indirect calorimetry (kcal/day)
Time frame: ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
acetaminophen test
Time frame: at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes
gallbladder emptying evaluated by ultrasound
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Blood samples
Time frame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Blood samples
University Hospital, Gentofte, Copenhagen
Other
Acronym: GASOLIN II
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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