The Role of Endogenous GLP-1 (Glycolipoprotein) in Regulating Glucose Stimulated Brain Activity
The Role of Endogenous GLP-1 in Regulating Glucose Stimulated Brain Activity
1 other identifier
interventional
12
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 7, 2013
CompletedAugust 7, 2013
August 1, 2013
1 year
May 8, 2013
August 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (6)
300ml tap water
PLACEBO COMPARATORSingle intragastric instillation of 300ml tap water via nasogastric tube
Glucose
ACTIVE COMPARATORSingle intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube
Glucose plus Lactisole
ACTIVE COMPARATORSingle intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole
Fructose
ACTIVE COMPARATORSingle intragastric instillation of 25g Fructose in 300ml tap water via nasogastric tube
Glucose and Exendin
ACTIVE COMPARATORSingle intragastric instillation of 75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39
tap water, lactisole
SHAM COMPARATORSingle intragastric instillation of 300ml tap water with 450ppm lactisole
Interventions
Eligibility Criteria
You may qualify if:
- right-handed healthy males, no drugs, non-smoking
You may not qualify if:
- drug abuse, smoker, left-handed, claustrophobia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital
Basel, CH-4031, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Beglinger, MD
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2013
First Posted
August 7, 2013
Study Start
March 1, 2012
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
August 7, 2013
Record last verified: 2013-08