Beta-Cell Function After Near-Normalisation of Blood Glucose

This study has been completed.
Sponsor:
Information provided by:
Hvidovre University Hospital
ClinicalTrials.gov Identifier:
NCT00612950
First received: January 16, 2008
Last updated: February 11, 2008
Last verified: January 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hvidovre University Hospital

Additional 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, KA 03005
Study First Received: January 16, 2008
Last Updated: February 11, 2008
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014