GIP/GLP-1 Co-Activity in Subjects With Obesity: Lowering of Food Intake
GASOLIN
1 other identifier
interventional
18
1 country
1
Brief Summary
We aim to delineate the effects of separate and combined infusion of GIP and GLP-1 on food intake, appetite, bone health and fat metabolism in overweight/obese subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Oct 2015
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 31, 2015
CompletedFirst Posted
Study publicly available on registry
November 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2016
CompletedDecember 6, 2018
December 1, 2018
9 months
October 31, 2015
December 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
food intake
How much does the participant eat of from the ad libitum meal, measured in gram
250-280 min
Secondary Outcomes (11)
hunger
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
satiety
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
Fullness
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
Prospective food consumption
measured at time 0, 30, 60, 90, 120, 180, 210, 240 min
resting energy expenditure (REE)
-15 to 0 min. and 210 to 225 min.
- +6 more secondary outcomes
Study Arms (5)
IIGI+GIP
ACTIVE COMPARATOR4 hour i.v. infusion of glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemic conditions
IIGI+GLP-1
ACTIVE COMPARATOR4 hour i.v. infusion of glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemic conditions
IIGI+NaCl (placebo)
PLACEBO COMPARATOR4 hour i.v. NaCl (placebo) during isoglycemic conditions
IIGI+GIP+GLP-1
ACTIVE COMPARATOR4 hour co-infusion of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1
50 g OGTT
OTHER50 g oral glucose tolerance test (OGTT)
Interventions
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
i.v. NaCl during isoglycemia
50 g oral glucose tolerance test
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Eligibility Criteria
You may qualify if:
- Caucasian men
- Age between 25 and 70 years
- Body mass index (BMI) between 25 and 40 kg/m2
You may not qualify if:
- Diabetes or prediabetes (defined as glycated haemoglobin (HbA1c) ≥ 43 mmol/mol)
- Anaemia (defined as haemoglobin \< 8.3 mmol/l)
- Any gastrointestinal disease that may interfere with the endpoint variables
- Anorexia, bulimia or binge eating disorder
- Allergy or intolerance to ingredients included in the standardised meals
- Tobacco smoking
- Any regular drug treatment that cannot be discontinued for minimum 18 hours
- Any physical or psychological condition that the investigator feels would interfere with trial participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Diabetesresearch, Gentofte hospital
Hellerup, 2900, Denmark
Related Publications (6)
Finan B, Ma T, Ottaway N, Muller TD, Habegger KM, Heppner KM, Kirchner H, Holland J, Hembree J, Raver C, Lockie SH, Smiley DL, Gelfanov V, Yang B, Hofmann S, Bruemmer D, Drucker DJ, Pfluger PT, Perez-Tilve D, Gidda J, Vignati L, Zhang L, Hauptman JB, Lau M, Brecheisen M, Uhles S, Riboulet W, Hainaut E, Sebokova E, Conde-Knape K, Konkar A, DiMarchi RD, Tschop MH. Unimolecular dual incretins maximize metabolic benefits in rodents, monkeys, and humans. Sci Transl Med. 2013 Oct 30;5(209):209ra151. doi: 10.1126/scitranslmed.3007218.
PMID: 24174327BACKGROUNDCampbell JE, Drucker DJ. Pharmacology, physiology, and mechanisms of incretin hormone action. Cell Metab. 2013 Jun 4;17(6):819-837. doi: 10.1016/j.cmet.2013.04.008. Epub 2013 May 16.
PMID: 23684623BACKGROUNDFlint A, Raben A, Astrup A, Holst JJ. Glucagon-like peptide 1 promotes satiety and suppresses energy intake in humans. J Clin Invest. 1998 Feb 1;101(3):515-20. doi: 10.1172/JCI990.
PMID: 9449682BACKGROUNDNissen A, Christensen M, Knop FK, Vilsboll T, Holst JJ, Hartmann B. Glucose-dependent insulinotropic polypeptide inhibits bone resorption in humans. J Clin Endocrinol Metab. 2014 Nov;99(11):E2325-9. doi: 10.1210/jc.2014-2547. Epub 2014 Aug 21.
PMID: 25144635BACKGROUNDBergmann NC, Lund A, Gasbjerg LS, Jorgensen NR, Jessen L, Hartmann B, Holst JJ, Christensen MB, Vilsboll T, Knop FK. Separate and Combined Effects of GIP and GLP-1 Infusions on Bone Metabolism in Overweight Men Without Diabetes. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2953-2960. doi: 10.1210/jc.2019-00008.
PMID: 30848791DERIVEDBergmann NC, Lund A, Gasbjerg LS, Meessen ECE, Andersen MM, Bergmann S, Hartmann B, Holst JJ, Jessen L, Christensen MB, Vilsboll T, Knop FK. Effects of combined GIP and GLP-1 infusion on energy intake, appetite and energy expenditure in overweight/obese individuals: a randomised, crossover study. Diabetologia. 2019 Apr;62(4):665-675. doi: 10.1007/s00125-018-4810-0. Epub 2019 Jan 25.
PMID: 30683945DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Natasha C Bergmann, MD
Center for Diabetesresearch, Gentofte Hospital, University of Copenhagen, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Ph.D student
Study Record Dates
First Submitted
October 31, 2015
First Posted
November 6, 2015
Study Start
October 1, 2015
Primary Completion
June 20, 2016
Study Completion
June 20, 2016
Last Updated
December 6, 2018
Record last verified: 2018-12