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Beta-Cell Function After Near-Normalisation of Blood Glucose

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00612950
First Posted: February 12, 2008
Last Update Posted: February 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hvidovre University Hospital
  Purpose
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.

Condition Intervention
Type 2 Diabetes Drug: glucagon-like peptide-1, Drug: glucose dependent insulinotropic polypeptide Drug: Saline

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 2.phase insulin response measured as incremental area under the curve from 10-120 minutes [ Time Frame: 2 hours ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: October 2006
Study Completion Date: May 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1 Drug: glucagon-like peptide-1,
GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
Experimental: GIP Drug: glucose dependent insulinotropic polypeptide
continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
Placebo Comparator: saline Drug: Saline
continuous infusion of Saline for 120 min

  Eligibility

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00612950


Locations
Denmark
Dept. of Endocrinology, Hvidovre Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Patricia V Højberg, MD, PHD University Hospital Hvidovre
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Patricia Verdugo Højberg/ MD, PHD, Kettegaard Alle 30, 2650 Hvidovre
ClinicalTrials.gov Identifier: NCT00612950     History of Changes
Other Study ID Numbers: KA 03005
First Submitted: January 16, 2008
First Posted: February 12, 2008
Last Update Posted: February 12, 2008
Last Verified: January 2008

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon
Gastric Inhibitory Polypeptide
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins