The Effect of the GLP-1 Analogue Exenatide on Type 2 Diabetes in CNS and Heart During Hyperglycemia Assessed by PET - Full Text View

Purpose

30 type 2 diabetic patients will be PET-scanned twice ( half of the patients heart-PET, half of the patients CNS-PET) in random order with infusions of placebo or GLP-1-analogue during hyperglycemic clamp to uncover the metabolic effects of GLP-1-analogues 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
Type 2 Diabetes	Drug: Byetta, Exenatide	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	The Effect of the GLP-1 Analogue Exenatide on Glucose Metabolism in the CNS and Heart During Hyperglycemia in Type-2 Diabetic Patients Assessed by PET

Resource links provided by NLM:

MedlinePlus related topics: Hyperglycemia

Drug Information available for: Exenatide

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:

steady glucose metabolism in the heart and brain during hyperglycemia with GLP-1-analogue infusion compared to placebo. [ Time Frame: oct. 2008 - oct 2010 ]


Enrollment:	8
Study Start Date:	February 2010
Study Completion Date:	March 2011
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: glp-1-analogue During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be heart OR CNS-PET scanned	Drug: Byetta, Exenatide Drug: Exenatide or placebo Dosage form: Infusion Dosage: Exenatide (Eli Lilly/Amylin Pharmaceuticals) 0.066 pmolkg-1min-1 Duration: 5 hours Frequency: Drug given once, placebo given once Other Name: placebo
Placebo Comparator: placebo During hyperglycemic clamp and GLP-1-analogue versus placebo infusion 15 patients will be CNS OR heart-PET scanned.	Drug: Byetta, Exenatide Drug: Exenatide or placebo Dosage form: Infusion Dosage: Exenatide (Eli Lilly/Amylin Pharmaceuticals) 0.066 pmolkg-1min-1 Duration: 5 hours Frequency: Drug given once, placebo given once Other Name: placebo

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Eligibility


Ages Eligible for Study:	50 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent signed
Caucasian
Male
Diabetes for > 6 months
Diet treatment or a single OAD (metformin, SU)
Age > 50 years and < 70 years
BMI 20-45 kg/m²
Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 11% inclusive.
Fasting PG 7-10 mmol/l
OAD discontinued 72 hours prior to study day 1

Exclusion Criteria:

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00747968

Locations


Denmark
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Aarhus C, Denmark, 8000
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Denmark, 8000 C
Aarhus University Hospital, Investigational Dept. M of Endocrinology
Aarhus, Denmark, 8000

Sponsors and Collaborators

University of Aarhus

Eli Lilly and Company

Aarhus University Hospital

Investigators


Principal Investigator:	michael g jensen, MD	Aarhus University, Institute of Pharmacology
Study Director:	Jørgen Rungby, Professor	Aarhus University, Institute of Pharmacology

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gejl M, Søndergaard HM, Stecher C, Bibby BM, Møller N, Bøtker HE, Hansen SB, Gjedde A, Rungby J, Brock B. Exenatide alters myocardial glucose transport and uptake depending on insulin resistance and increases myocardial blood flow in patients with type 2 diabetes. J Clin Endocrinol Metab. 2012 Jul;97(7):E1165-9. doi: 10.1210/jc.2011-3456. Epub 2012 Apr 27.


Responsible Party:	MD, michael gejl jensen, Aarhus University Hospital, Aarhus
ClinicalTrials.gov Identifier:	NCT00747968 History of Changes
Other Study ID Numbers:	Brainandheart
Study First Received:	September 5, 2008
Last Updated:	June 29, 2011

Additional relevant MeSH terms:


Diabetes Mellitus, Type 2 Hyperglycemia Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Exenatide Glucagon-Like Peptide 1	Glucagon Hypoglycemic Agents Physiological Effects of Drugs Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 18, 2017