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

Obesity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232244
• Other study ID #: OXMDissek
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: December 9, 2013
• Start date: October 2010
• Est. completion date: January 2012

Study information

• Verified date: December 2013
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Data Protection AgencyDenmark: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Incretin Action
• Obesity

Intervention

Other:
• GLP-1 infusion
1 pmol/kg/min
• Glucagon infusion
3ng/kg/min
• Oxyntomodulin infusion
3 pmol/kg/min
• GLP-1 and glucagon infusion
1 pmol/kg/min 3 ng/kg/min
• Placebo
NaCl 9 g/L infusion

Locations

Country	Name	City	State
Denmark	Gentofte University Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gastric emptying	Assessed by the acetaminophen - method	4 h	No
Primary	Satiety	Assessed by VAS	4 h	No
Primary	Hunger	Assessed by an ad'libitum meal	4 h	No
Primary	basal energy expenditure	Assessed by indirect calorimetry	2 x 30min	No
Secondary	GLP-1		4 h	No
Secondary	Oxyntomodulin		4 h	No
Secondary	Glucagon		4 h	No
Secondary	GIP		4 h	No