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ObesityGASOLINNCT02598791

GIP/GLP-1 Co-Activity in Subjects With Obesity: Lowering of Food Intake

A study testing IIGI+GIP, IIGI+GLP-1 and OGTT in people with Obesity and Adiposity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Adiposity, Type 2 Diabetes
What is being tested?
IIGI+GIP, IIGI+GLP-1 and OGTT
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteDenmark
Study dates
1 Oct 2015to 20 Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Caucasian men
  • Age between 25 and 70 years
  • Body mass index (BMI) between 25 and 40 kg/m2

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Center for Diabetesresearch, Gentofte hospital

    Hellerup, 2900

Other trials in Denmark

About this study

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.

Read the detailed description

The gut-derived incretin glucagon-like peptide-1 (GLP-1) is a potent regulator of gastric emptying, appetite and food intake in humans whereas its sister incretin hormone, glucose-dependent insulinotropic polypeptide (GIP), does not seem to have independent effects on these variables in humans. Interestingly, recent data from rodents have shown that concomitant activation of the GIP and the GLP-1 receptor may potentiate the satiety-promoting and body weight-reducing effects of GLP-1. Also, evidence suggests that GIP may be an important mediator of bone remodelling and lipid deposition. The effect of simultaneous activation of the GIP and GLP-1 receptors on appetite, food intake, fat metabolism and bone health has not been thoroughly examined in humans. The aim of this study is to delineate the effects of GIP/GLP-1 receptor co-activation on food intake, mechanisms regulating food intake, fat and bone metabolism in obese subjects.

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.

Being tested
IIGI+GIP, IIGI+GLP-1, IIGI+NaCl (placebo), OGTT, IIGI+GIP+GLP-1
Keywords
incretin hormones, GIP, GLP-1
Medical subject headings
Obesity, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IIGI+GIPOther

    Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia

  • IIGI+GLP-1Other

    glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia

  • IIGI+NaCl (placebo)Other

    i.v. NaCl during isoglycemia

  • OGTTOther

    50 g oral glucose tolerance test

  • IIGI+GIP+GLP-1Other

    i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia

Study groups in NCT02598791
Study groupRoleWhat they receive
IIGI+GIPActive comparator4 hour i.v. infusion of glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemic conditions
Receives: Other: IIGI+GIP; Other: IIGI+GLP-1; Other: IIGI+NaCl (placebo); Other: OGTT; Other: IIGI+GIP+GLP-1
IIGI+GLP-1Active comparator4 hour i.v. infusion of glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemic conditions
Receives: Other: IIGI+GIP; Other: IIGI+GLP-1; Other: IIGI+NaCl (placebo); Other: OGTT; Other: IIGI+GIP+GLP-1
IIGI+NaCl (placebo)Placebo comparator4 hour i.v. NaCl (placebo) during isoglycemic conditions
Receives: Other: IIGI+GIP; Other: IIGI+GLP-1; Other: IIGI+NaCl (placebo); Other: OGTT; Other: IIGI+GIP+GLP-1
IIGI+GIP+GLP-1Active comparator4 hour co-infusion of glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1
Receives: Other: IIGI+GIP; Other: IIGI+GLP-1; Other: IIGI+NaCl (placebo); Other: OGTT; Other: IIGI+GIP+GLP-1
50 g OGTTOther50 g oral glucose tolerance test (OGTT)
Receives: Other: IIGI+GIP; Other: IIGI+GLP-1; Other: IIGI+NaCl (placebo); Other: OGTT; Other: IIGI+GIP+GLP-1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. food intake

    How much does the participant eat of from the ad libitum meal, measured in gram

    Measured: 250-280 min

Secondary outcomes (11)
  1. hunger

    feeling of hunger measured on a visual analogue scale

    Measured: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min

  2. satiety

    feeling of satiety measured on a visual analogue scale

    Measured: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min

  3. Fullness

    feeling of fullness measured on a visual analogue scale

    Measured: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min

  4. Prospective food consumption

    Prospective food consumption measured on a visual analogue scale

    Measured: measured at time 0, 30, 60, 90, 120, 180, 210, 240 min

  5. resting energy expenditure (REE)

    changes in REE measured by a ventilated hood 15 minutes at baseline and 15 minutes at time point 210 min.

    Measured: -15 to 0 min. and 210 to 225 min.

  6. Insulin

    changes in insulin measured in serum

    Measured: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min

  7. C-peptide level

    changes in C-peptide level measured in serum

    Measured: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min

  8. glucagon levels

    changes in glucagon levels measured in plasma

    Measured: -30, 0, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 min

  9. Cholesterol and FFA

    changes in cholesterol (TAG, Total cholesterol and free fatty acid measured in plasma)

    Measured: -30, 0, 30, 60, 90, 120, 180, 240 min

  10. C-terminal cross-linked telopeptide of bone collagen (CTX)

    changes in level of CTX measured in plasma

    Measured: -30, 0, 30, 60, 90, 120, 180, 240 min

  11. procollagen type 1 N-terminal propeptide (P1NP)

    changes in level of P1NP measured in plasma

    Measured: -30, 0, 30, 60, 90, 120, 180, 240 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2015 (estimated)
  2. Study start1 Oct 2015
  3. Primary completion20 Jun 2016
  4. Study completion20 Jun 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02598791
Sponsor's protocol ID
H-15008790 (GASOLIN)
Acronym
GASOLIN
Status last verified
Dec 2018
First submitted
31 Oct 2015
Last updated
6 Dec 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24174327
  • 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.

    PubMed 23684623
  • 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.

    PubMed 9449682
  • 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.

    PubMed 25144635
  • 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.

    PubMed 30848791
  • 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.

    PubMed 30683945

Questions about this trial

What is this clinical trial studying?

A study testing IIGI+GIP, IIGI+GLP-1 and OGTT in people with Obesity and Adiposity, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

food intake (time frame: 250-280 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02598791, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2018.

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