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

This study is ongoing, but not recruiting participants.
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 13, 2011
Last verified: December 2011
History of Changes

November 1, 2010
December 13, 2011
October 2010
January 2012   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01232244 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Oxyntomodulin, Mechanisms of Action in Relation to Appetite, Food Intake, Gastric Emptying and Energy Expenditure.
Not Provided

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.
Not Provided
Observational
Not Provided
Not Provided
Retention:   Samples With DNA
Description:

blood samples
Non-Probability Sample

Healthy young males
  • Incretin Action
  • Obesity
  • 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
Healthy young males
Interventions:
  • Other: GLP-1 infusion
  • Other: Glucagon infusion
  • Other: Oxyntomodulin infusion
  • Other: GLP-1 and glucagon infusion
  • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
15
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Male
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01232244
OXMDissek
No
Jonatan I Bagger, University Hospital, Gentofte, Copenhagen
University Hospital, Gentofte, Copenhagen
Not Provided
Principal Investigator: Jonatan I Bagger, MD Gentofte University Hospital, University of Copenhagen
University Hospital, Gentofte, Copenhagen
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP