Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2011-04-30
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Glucotoxicity Trial
Insulin secretion will be assessed using a hyperglycemic clamp combined with GLP-1, GIP, and arginine infusions.
The clamp will be performed before and after 24 hours of bed rest, isocaloric meal feeding, and experimental elevation of blood glucose.
Glucotoxicity
Glucose will be infused intravenously for a 24 hour period to raise blood glucose concentrations 5 mM above basal.
Control Trial
Insulin secretion will be assessed using a hyperglycemic clamp combined with GLP-1, GIP, and arginine infusions.
The clamp will be performed before and after 24 hours of bed rest and isocaloric meal feeding.
No interventions assigned to this group
Lipotoxicity Trial
Insulin secretion will be assessed using a hyperglycemic clamp combined with GLP-1, GIP, and arginine infusions.
The clamp will be performed before and after 24 hours of bed rest, isocaloric meal feeding, and experimental elevation of blood free fatty acids.
Lipotoxicity
Intralipid and heparin will be infused intravenously for a 24 hour period to raise blood free fatty acid concentrations to approximately 1 mM.
Interventions
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Glucotoxicity
Glucose will be infused intravenously for a 24 hour period to raise blood glucose concentrations 5 mM above basal.
Lipotoxicity
Intralipid and heparin will be infused intravenously for a 24 hour period to raise blood free fatty acid concentrations to approximately 1 mM.
Eligibility Criteria
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Inclusion Criteria
* diagnosed type 2 diabetic (confirmed with OGTT)
Exclusion Criteria
* age \<18 or \>65 years
* BMI \<20 or \> 35 kg/m2
* evidence of hematological, pulmonary, hepatic, renal, or cardiovascular disease
* actively undergoing weight-loss (\>2kg change in last 6 months)
* bariatric surgery (gastric by-pass or banding)
* pregnancy
* smoking
18 Years
65 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Thomas Solomon
Group Leader
Principal Investigators
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Thomas P Solomon, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Centre of Inflammation and Metabolism, Rigshospitalet
Copenhagen, , Denmark
Countries
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Other Identifiers
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H-3-2010-127
Identifier Type: -
Identifier Source: org_study_id