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Glucolipotoxicity and Type 2 Diabetes

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Thomas Solomon, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01375270
First received: June 14, 2011
Last updated: March 14, 2013
Last verified: March 2013

June 14, 2011
March 14, 2013
April 2011
December 2013   (final data collection date for primary outcome measure)
Insulin Secretion [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Insulin secretion will be assessed in response to intravenous infusions of glucose, GLP-1, GIP, and arginine, and in response to meal ingestion.
Same as current
Complete list of historical versions of study NCT01375270 on ClinicalTrials.gov Archive Site
  • Insulin Sensitivity [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Glucose kinetics will be assesed using [6,6-2H2]glucose. Rate of glucose disappearance during glucose infusion will be quantified per unit of plasma insulin to derive an estimate of insulin sensitivity.
  • Plasma Cytokines (IL-6, TNF, IL-1beta, IL-1ra) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Cytokines will be measured in plasma: IL-6, TNF-alpha, IL-1beta, IL-1 receptor antagonist, IL-8, IL-10, Interferon gamma. Peripheral blood mononuclear cells will be isolated.
Same as current
Not Provided
Not Provided
 
Glucolipotoxicity and Type 2 Diabetes
The Effects of Experimental Elevation of Plasma Glucose and Lipid on Pancreatic Beta-cell Function in Humans

Elevations of blood glucose and lipid are thought to be deleterious to the insulin secretory function of the pancreas. This is known as glucolipotoxicity. However, few studies have examined this in detail. This investigation will examine pancreatic insulin secretory function in physiological models of glucolipotoxicity such as obese and type 2 diabetic individuals. Furthermore, healthy subjects will undergo 24 hour infusion of glucose or Intralipid to induce experimental models of glucolipotoxicity. Insulin secretion in response to intravenous infusions of glucose, GLP-1, GIP, and arginine and in response to meal ingestion, will be examined. the investigators hypothesize that experimental glucolipotoxicity will impairs pancreatic insulin secretory function to levels akin to that seen in type 2 diabetics.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Procedure: Glucotoxicity
    Glucose will be infused intravenously for a 24 hour period to raise blood glucose concentrations 5 mM above basal.
  • Procedure: Lipotoxicity
    Intralipid and heparin will be infused intravenously for a 24 hour period to raise blood free fatty acid concentrations to approximately 1 mM.
  • Experimental: 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.

    Intervention: Procedure: Glucotoxicity
  • No Intervention: 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.

  • Experimental: 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.

    Intervention: Procedure: Lipotoxicity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
36
Not Provided
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • normal glucose tolerance based on screening OGTT or
  • diagnosed type 2 diabetic (confirmed with OGTT)

Exclusion Criteria:

  • insulin dependent diabetes
  • 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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01375270
H-3-2010-127
No
Thomas Solomon, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Thomas P Solomon, Ph.D. Rigshospitalet, Denmark
Rigshospitalet, Denmark
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP