GIP/GLP-1 Co-Activity in Subjects With Obesity: Lowering of Food Intake
NCT ID: NCT02598791
Last Updated: 2018-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2015-10-01
2016-06-20
Brief Summary
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Detailed Description
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Material and methods:
The investigators plan to include 18 obese/overweight men without diabetes. The primary endpoint of the study is food intake during continuous intravenous infusions of saline (placebo), GIP, GLP-1 and GIP+GLP-1, respectively. Secondary endpoints includes resting energy expenditure (measured by indirect calorimetry), appetite, satiety and hunger assessments (measured by visual analogue scales), plasma insulin, C-peptide and glucagon secretion, plasma triglycerides, cholesterols, and free fatty acid responses and changes in plasma bone turnover markers.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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IIGI+GIP
4 hour i.v. infusion of glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemic conditions
IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
OGTT
50 g oral glucose tolerance test
IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
IIGI+GLP-1
4 hour i.v. infusion of glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemic conditions
IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
OGTT
50 g oral glucose tolerance test
IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
IIGI+NaCl (placebo)
4 hour i.v. NaCl (placebo) during isoglycemic conditions
IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
OGTT
50 g oral glucose tolerance test
IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
IIGI+GIP+GLP-1
4 hour co-infusion of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1
IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
OGTT
50 g oral glucose tolerance test
IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
50 g OGTT
50 g oral glucose tolerance test (OGTT)
IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
OGTT
50 g oral glucose tolerance test
IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Interventions
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IIGI+GIP
Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
IIGI+GLP-1
glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
IIGI+NaCl (placebo)
i.v. NaCl during isoglycemia
OGTT
50 g oral glucose tolerance test
IIGI+GIP+GLP-1
i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
Eligibility Criteria
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Inclusion Criteria
* Age between 25 and 70 years
* Body mass index (BMI) between 25 and 40 kg/m2
Exclusion Criteria
* 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
25 Years
70 Years
MALE
Yes
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Natasha Chidekel Bergmann
MD Ph.D student
Principal Investigators
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Natasha C Bergmann, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Diabetesresearch, Gentofte Hospital, University of Copenhagen, Denmark
Locations
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Center for Diabetesresearch, Gentofte hospital
Hellerup, , Denmark
Countries
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References
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Bergmann 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.
Bergmann 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.
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.
Campbell 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.
Flint 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.
Nissen 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.
Other Identifiers
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H-15008790 (GASOLIN)
Identifier Type: -
Identifier Source: org_study_id
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