Effect of GLP-1 on Glucose Metabolism in CNS Assessed by PET

This study has been completed.
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01185119
First received: August 18, 2010
Last updated: March 21, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: native glp-1 (7-36)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Effect of Native GLP-1 on Glucose Metabolism in the CNS During Hyperglycemia in Healthy Young Men Assessed by PET

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • steady glucose metabolism in the brain during hyperglycemia with Native GLP-1 infusion compared to placebo. [ Time Frame: june 2010 - dec 2010 ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: GLP-1
During hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
Drug: native glp-1 (7-36)
During hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
Other Name: glucagon like peptide-1 (7-36)
Placebo Comparator: placebo
During hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
Drug: native glp-1 (7-36)
During hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
Other Name: glucagon like peptide-1 (7-36)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Informed consent signed
  • Caucasian
  • Male
  • Age > 20 years and < 50 years
  • BMI 20-30 kg/m² -

Exclusion Criteria:

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
    • Loss of more than 100 ml blood within the latest month of inclusion
    • Compliance problems
    • Abuse of alcohol or drugs
    • Smoking
    • Participation in a clinical research study within 3 months of inclusion
    • Allergy towards study hormones
    • Medication with any drugs with effects on the glucose-metabolism, including *glitazones
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01185119

Locations
Denmark
Aarhus University, Institute of Pharmacology
Aarhus C, Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Birgitte Brock, asso.prof. University of Aarhus, Dept. of Pharmacology
  More Information

No publications provided

Responsible Party: Birgitte Brock, asso. prof., Aarhus University, Aarhus
ClinicalTrials.gov Identifier: NCT01185119     History of Changes
Other Study ID Numbers: H80-CP-O015
Study First Received: August 18, 2010
Last Updated: March 21, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
glucose uptake and metabolism in brain

Additional relevant MeSH terms:
Glucagon-Like Peptide 1
Glucagon
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014