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Near Normalisation of BG Improves the Potentiating Effect of GLP-1

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00612625
First received: January 16, 2008
Last updated: February 11, 2008
Last verified: January 2008
History of Changes

January 16, 2008
February 11, 2008
February 2004
July 2004   (final data collection date for primary outcome measure)
insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00612625 on ClinicalTrials.gov Archive Site
The calculated ISR values was plotted against the ambient plasma glucose. The slopes of this linear relationships were calculated by cross-correlation analysis and is and estimation of beta-cell responsiveness (pmol/kg/min)/mmol/l [ Time Frame: 180 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Near Normalisation of BG Improves the Potentiating Effect of GLP-1
Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes

The ability of glucagon-like peptide 1 to enhance beta-cell responsiveness to I.v. glucose is impaired in patients with type 2 diabetes mellitus compared with healthy individuals. We investigated whether 4 weeks of near-normalisation og blood glucose improves the potentiation of glucose-stimulated insulin secretion by GLP-1
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Diabetes Mellitus Type 2
  • Drug: glucagon-like peptide-1
    continuous infusion of GLP-1 (1½ pmol/kg/min)
  • Drug: Saline
    continuous infusion of saline
  • Experimental: GLP-1
    A graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min)
    Intervention: Drug: glucagon-like peptide-1
  • Experimental: Saline
    A graded glucose infusion together with a continuous infusion of saline
    Intervention: Drug: Saline
Højberg PV, Zander M, Vilsbøll T, Knop FK, Krarup T, Vølund A, Holst JJ, Madsbad S. Near normalisation of blood glucose improves the potentiating effect of GLP-1 on glucose-induced insulin secretion in patients with type 2 diabetes. Diabetologia. 2008 Apr;51(4):632-40. Epub 2008 Feb 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9
December 2004
July 2004   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 18-70 years
  • Type 2 diabetes diagnosed after 30 years of age
  • BMI > 25

Exclusion Criteria:

  • Severe complications to diabetes
  • Abnormal liver og kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00612625
KF 01 - 198/03, KA 01 - 198/03
No
Patricia Verdugo Højberg, MD, PHD, Patricia Verdugo Højberg
Hvidovre University Hospital
Not Provided
Principal Investigator: Patricia V Højberg, MD, PHD University Hospital Hvidovre
Hvidovre University Hospital
January 2008

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