GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake (GASOLIN II)
Primary Purpose
Type 2 Diabetes Mellitus, Overweight and Obesity
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GIP1-42 infusion
Saline
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus
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
Sites / Locations
- Center for diabetes research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
GIP infusion
Saline
Arm Description
5 hours of continuously GIP1-42 infusion
5 hours of continuously saline infusion
Outcomes
Primary Outcome Measures
food intake
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
Secondary Outcome Measures
Appetite
Appetite rated on visual analogue scales (0-10 mm)
satiety
Satiety rated on visual analogue scales (0-10 mm)
prospective food consumption
prospective food consumption rated on visual analogue scales (0-10 mm)
fullness
fullness rated on visual analogue scales (0-10 mm)
Thirst
Thirst rated on visual analogue scales (0-10 mm)
Nausea
Nausea rated on visual analogue scales (0-10 mm)
Energy expenditure
resting energy expenditure measured by indirect calorimetry (kcal/day)
gastric emptying
acetaminophen test
gallbladder emptying
gallbladder emptying evaluated by ultrasound
glucagon responses
blood samples
Insulin responses
blood samples
C-peptide responses
blood samples
gut hormone responses
Blood samples
bone turnover markers
Blood samples
Full Information
NCT ID
NCT03526289
First Posted
October 24, 2017
Last Updated
December 4, 2018
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Zealand Pharma
1. Study Identification
Unique Protocol Identification Number
NCT03526289
Brief Title
GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
Acronym
GASOLIN II
Official Title
GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
October 24, 2018 (Actual)
Study Completion Date
October 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Zealand Pharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Overweight and Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GIP infusion
Arm Type
Active Comparator
Arm Description
5 hours of continuously GIP1-42 infusion
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
5 hours of continuously saline infusion
Intervention Type
Biological
Intervention Name(s)
GIP1-42 infusion
Intervention Description
5-hour GIP1-42 infusion (time point 0-300 minutes)
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
5-hour infusion of saline (placebo) (time point 0-300 minutes)
Primary Outcome Measure Information:
Title
food intake
Description
food intake (kJ) eaten from an ad libitum meal of pasta bolognese
Time Frame
time point 300-330 minutes
Secondary Outcome Measure Information:
Title
Appetite
Description
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
Title
satiety
Description
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
Title
prospective food consumption
Description
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
Title
fullness
Description
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
Title
Thirst
Description
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
Title
Nausea
Description
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
Title
Energy expenditure
Description
resting energy expenditure measured by indirect calorimetry (kcal/day)
Time Frame
measured at baseline and at time point 250 minutes
Title
gastric emptying
Description
acetaminophen test
Time Frame
ingested at time point -15, 0, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Title
gallbladder emptying
Description
gallbladder emptying evaluated by ultrasound
Time Frame
at time point -15, 0, 30, 60, 90, 120, 150, 180, 240 minutes
Title
glucagon responses
Description
blood samples
Time Frame
at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Title
Insulin responses
Description
blood samples
Time Frame
at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Title
C-peptide responses
Description
blood samples
Time Frame
at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Title
gut hormone responses
Description
Blood samples
Time Frame
at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
Title
bone turnover markers
Description
Blood samples
Time Frame
at time point -15, 0, 30, 45, 60, 75, 90, 105, 120, 150, 180, 210 and 270 minutes
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
male fænotype
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Center for diabetes research
City
Hellerup
ZIP/Postal Code
DK-2900
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31949084
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.
Results Reference
derived
Learn more about this trial
GIP/GLP-1 Co-Activity in Subjects With Overweight and Type 2 Diabetes: Lowering of Food Intake
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