Clinical trial NCT03526289: GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
Official title: GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Overweight and Obesity
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Zealand Pharma
First posted: 2018-05-16
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion criteria:

* Caucasian men
* Age between 18 and 70 years
* Body mass index (BMI) between 25 and 40 kg/m2
* Type 2 diabetes (diagnosed according to the criteria of the World Health Organization) with HbA1c \<69 mM (\<8.5 %)
* In stable treatment for ≥3 months with metformin ≥1 g and a GLP-1 receptor agonist.
* Informed consent

Exclusion criteria

* Anaemia (haemoglobin outside normal range)
* Any current or prior gastrointestinal disease that may interfere with the endpoint variables
* Liver disease (alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) \> 2 times normal values) or history of hepatobiliary disorder.
* Nephropathy (serum creatinine above normal range and/or albuminuria).
* Anorexia, bulimia or binge eating disorder
* Allergy or intolerance to ingredients included in the standardised meals
* Tobacco smoking
* Treatment with other glucose lowering drugs than GLP-1 receptor agonists and metformin.
* Any regular drug treatment (besides metformin and GLP-1 receptor agonists) that cannot be discontinued for a minimum of 12 hours
* Any physical or psychological condition that the investigator feels would interfere with trial participation

Primary outcomes:
measure: food intake
timeFrame: time point 300-330 minutes
Secondary outcomes:
measure: Appetite
timeFrame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
measure: satiety
timeFrame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
measure: prospective food consumption
timeFrame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
measure: fullness
timeFrame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
measure: Thirst
timeFrame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
measure: Nausea
timeFrame: time point -30, 0, 30, 60, 90, 120, 150, 180, 210, 240, 270 minutes
measure: Energy expenditure
timeFrame: measured at baseline and at time point 250 minutes
measure: gastric emptying
timeFrame: ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
measure: gallbladder emptying
timeFrame: at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes
measure: glucagon responses
timeFrame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
measure: Insulin responses
timeFrame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
measure: C-peptide responses
timeFrame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
measure: gut hormone responses
timeFrame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
measure: bone turnover markers
timeFrame: at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Center for diabetes research
Study officials:
References:
citation: Bergmann NC, Gasbjerg LS, Heimburger SM, Krogh LSL, Dela F, Hartmann B, Holst JJ, Jessen L, Christensen MB, Vilsboll T, Lund A, Knop FK. No Acute Effects of Exogenous Glucose-Dependent Insulinotropic Polypeptide on Energy Intake, Appetite, or Energy Expenditure When Added to Treatment With a Long-Acting Glucagon-Like Peptide 1 Receptor Agonist in Men With Type 2 Diabetes. Diabetes Care. 2020 Mar;43(3):588-596. doi: 10.2337/dc19-0578. Epub 2020 Jan 16.