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Completed

NCT Number: NCT01232244

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

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.

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Key information

Conditions

Incretin Action Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Male

Study type

Observational

Primary location

Gentofte University Hospital

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GLP-1 infusion

Other

1 pmol/kg/min

Glucagon Infusion

Other

3ng/kg/min

Oxyntomodulin infusion

Other

3 pmol/kg/min

GLP-1 and glucagon infusion

Other

1 pmol/kg/min 3 ng/kg/min

Placebo

Other

NaCl 9 g/L infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 2, 2010
Registry last updated
Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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