Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01232244
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : December 10, 2013
Information provided by (Responsible Party):
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen

Brief Summary:

Tiny molecules (hormones) are released from the bowels and other organs to the bloodstream in response to meals in order to orchestrate the metabolism. Oxyntomodulin, GLP-1 and glucagon are all known to regulate parameters such as appetite, food intake and induce weight loss.

Therefore we want to investigate mechanistic relations between the three hormones.

Condition or disease Intervention/treatment
Incretin Action Obesity Other: GLP-1 infusion Other: Glucagon infusion Other: Oxyntomodulin infusion Other: GLP-1 and glucagon infusion Other: Placebo

Study Type : Observational
Actual Enrollment : 15 participants
Study Start Date : October 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Group/Cohort Intervention/treatment
Healthy young males Other: GLP-1 infusion
1 pmol/kg/min

Other: Glucagon infusion

Other: Oxyntomodulin infusion
3 pmol/kg/min

Other: GLP-1 and glucagon infusion
1 pmol/kg/min 3 ng/kg/min

Other: Placebo
NaCl 9 g/L infusion

Primary Outcome Measures :
  1. Gastric emptying [ Time Frame: 4 h ]
    Assessed by the acetaminophen - method

  2. Satiety [ Time Frame: 4 h ]
    Assessed by VAS

  3. Hunger [ Time Frame: 4 h ]
    Assessed by an ad'libitum meal

  4. basal energy expenditure [ Time Frame: 2 x 30min ]
    Assessed by indirect calorimetry

Secondary Outcome Measures :
  1. GLP-1 [ Time Frame: 4 h ]
  2. Oxyntomodulin [ Time Frame: 4 h ]
  3. Glucagon [ Time Frame: 4 h ]
  4. GIP [ Time Frame: 4 h ]

Biospecimen Retention:   Samples With DNA
blood samples

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy young males

Inclusion Criteria:

  • Normal fasting plasma glucose
  • Normal glucose tolerance
  • Normal haemoglobin levels
  • Informed content

Exclusion Criteria:

  • Diabetes
  • Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
  • 1st degree relatives with diabetes
  • Obesity (BMI > 30)
  • Inflammatory bowels disease
  • Bowels surgery
  • Nephropathy
  • Liver disease
  • Medication which cannot be on hold for 24h

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01232244

Gentofte University Hospital
Hellerup, Denmark, 2900
Sponsors and Collaborators
University Hospital, Gentofte, Copenhagen
Principal Investigator: Jonatan I Bagger, MD Gentofte University Hospital, University of Copenhagen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen Identifier: NCT01232244     History of Changes
Other Study ID Numbers: OXMDissek
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Jonatan I Bagger, University Hospital, Gentofte, Copenhagen:
Incretin hormones
Energy expenditure

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs