The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity

Exploratory Behavior Clinical Trial

Official title:

The Role of Endogenous GLP-1 in Regulating Glucose Stimulated Brain Activity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918566
• Other study ID #: EKBB 298/12
• Status: Completed
• Phase: N/A
• First received: May 8, 2013
• Last updated: August 5, 2013
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2013
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Our objective is to investigate neuro-anatomical correlates of the regulation of energy intake by means of functional MRI. Administration of glucose with and without lactisole and exendin as well as fructose is followed by functional brain MRI, and findings are correlated with serum GLP-1 levels as an endogenous satiety signal in humans.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• right-handed healthy males, no drugs, non-smoking

Exclusion Criteria:

• drug abuse, smoker, left-handed, claustrophobia

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Exploratory Behavior

Intervention

Dietary Supplement:
• tap water

• Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube

• Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole

• 25g Fructose in 300ml tap water

• 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39

• 300ml tap water with 450ppm lactisole

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task: changes in cerebral blood flow and blood hormones from baseline to treatment	Whole brain analysis with a cluster-level threshold was followed by an a priori defined region of interest analysis of the dorsolateral prefrontal cortex including a cluster-level threshold and family-wise error adjustment for multiple comparisons.	changes from baseline to one hour after treatment	No