Effect of GLP-1 on Glucose Metabolism in CNS Assessed by PET
The Effect of Native GLP-1 on Glucose Metabolism in the CNS During Hyperglycemia in Healthy Young Men Assessed by PET
1 other identifier
interventional
10
1 country
1
Brief Summary
10 healthy men will be PET-scanned (CNS) twice in random order with infusions of placebo or Native GLP-1 during hyperglycemic clamp to uncover the metabolic effects of GLP-1 in perspectives of intervention of macrovascular late diabetic pathology such as stroke and AMI. Earlier studies have revealed tendencies towards steady glucose metabolism in the CNS despite fluctuations in blood sugar when infusing native GLP-1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 healthy
Started Jun 2010
Shorter than P25 for phase_2 healthy
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
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 18, 2010
CompletedFirst Posted
Study publicly available on registry
August 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 22, 2011
March 1, 2011
6 months
August 18, 2010
March 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
steady glucose metabolism in the brain during hyperglycemia with Native GLP-1 infusion compared to placebo.
june 2010 - dec 2010
Study Arms (2)
GLP-1
ACTIVE COMPARATORDuring hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
placebo
PLACEBO COMPARATORDuring hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
Interventions
During hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
Eligibility Criteria
You may qualify if:
- Informed consent signed
- Caucasian
- Male
- Age \> 20 years and \< 50 years
- BMI 20-30 kg/m² -
You may not qualify if:
- Diabetes og first degree relative diabetes
- Clinically significant liver- or kidney-disease (se-ALAT \> 2 times upper reference, or se-Creatinin \> 130 mM
- Anemia
- Other abnormal biochemical value
- Any of the following:
- Heart disease
- Liver disease
- Kidney disease
- Lung disease
- Gastro-intestinal disease
- Dyslipidemia (total serum-cholesterol \> 8 mmol/l, total cholesterol/HDL cholesterol ratio \> 8 or se-triglyceride \> 3.5 mmol/l)
- Endocrine disease (other than diabetes)
- CNS disease
- Hematological disease
- Compliance problems
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aarhus University, Institute of Pharmacology
Aarhus C, Aarhus, 8000, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Birgitte Brock, asso.prof.
University of Aarhus, Dept. of Pharmacology
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 18, 2010
First Posted
August 19, 2010
Study Start
June 1, 2010
Primary Completion
December 1, 2010
Study Completion
March 1, 2011
Last Updated
March 22, 2011
Record last verified: 2011-03