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Beta-Cell Function After Near-Normalisation of Blood Glucose

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ClinicalTrials.gov Identifier: NCT00612950
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : February 12, 2008
Sponsor:
Information provided by:
Hvidovre University Hospital

Tracking Information
First Submitted Date  ICMJE January 16, 2008
First Posted Date  ICMJE February 12, 2008
Last Update Posted Date February 12, 2008
Study Start Date  ICMJE October 2006
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
2.phase insulin response measured as incremental area under the curve from 10-120 minutes [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2008)
2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment [ Time Frame: 2 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beta-Cell Function After Near-Normalisation of Blood Glucose
Official Title  ICMJE Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes
Brief Summary The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: glucagon-like peptide-1,
    GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
  • Drug: glucose dependent insulinotropic polypeptide
    continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
  • Drug: Saline
    continuous infusion of Saline for 120 min
Study Arms  ICMJE
  • Experimental: GLP-1
    Intervention: Drug: glucagon-like peptide-1,
  • Experimental: GIP
    Intervention: Drug: glucose dependent insulinotropic polypeptide
  • Placebo Comparator: saline
    Intervention: Drug: Saline
Publications * Højberg PV, Vilsbøll T, Rabøl R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2008)
8
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Actual Primary Completion Date February 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 and kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00612950
Other Study ID Numbers  ICMJE KA 03005
KA 03005
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Patricia Verdugo Højberg/ MD, PHD, Kettegaard Alle 30, 2650 Hvidovre
Study Sponsor  ICMJE Hvidovre University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Patricia V Højberg, MD, PHD University Hospital Hvidovre
PRS Account Hvidovre University Hospital
Verification Date January 2008

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