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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier:
NCT01232244
First received: November 1, 2010
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Incretin Action
Obesity
Other: GLP-1 infusion
Other: Glucagon infusion
Other: Oxyntomodulin infusion
Other: GLP-1 and glucagon infusion
Other: Placebo

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by University Hospital, Gentofte, Copenhagen:

Primary Outcome Measures:
  • Gastric emptying [ Time Frame: 4 h ] [ Designated as safety issue: No ]
    Assessed by the acetaminophen - method

  • Satiety [ Time Frame: 4 h ] [ Designated as safety issue: No ]
    Assessed by VAS

  • Hunger [ Time Frame: 4 h ] [ Designated as safety issue: No ]
    Assessed by an ad'libitum meal

  • basal energy expenditure [ Time Frame: 2 x 30min ] [ Designated as safety issue: No ]
    Assessed by indirect calorimetry


Secondary Outcome Measures:
  • GLP-1 [ Time Frame: 4 h ] [ Designated as safety issue: No ]
  • Oxyntomodulin [ Time Frame: 4 h ] [ Designated as safety issue: No ]
  • Glucagon [ Time Frame: 4 h ] [ Designated as safety issue: No ]
  • GIP [ Time Frame: 4 h ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples


Enrollment: 15
Study Start Date: October 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy young males Other: GLP-1 infusion
1 pmol/kg/min
Other: Glucagon infusion
3ng/kg/min
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy young males

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01232244

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

No publications provided

Responsible Party: Jonatan I Bagger, MD, University Hospital, Gentofte, Copenhagen
ClinicalTrials.gov Identifier: NCT01232244     History of Changes
Other Study ID Numbers: OXMDissek
Study First Received: November 1, 2010
Last Updated: December 9, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Data Protection Agency
Denmark: The Ministry of the Interior and Health

Keywords provided by University Hospital, Gentofte, Copenhagen:
Incretin hormones
Glucagon
Satiety
Hunger
Energy expenditure

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

ClinicalTrials.gov processed this record on September 30, 2014