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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
  Purpose

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


Condition Intervention
Diabetes Mellitus Type 2
 Drug: glucagon-like peptide-1
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: Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hvidovre University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 9
Study Start Date: February 2004
Study Completion Date: December 2004
Primary Completion Date: July 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GLP-1
A graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min)
 Drug: glucagon-like peptide-1
continuous infusion of GLP-1 (1½ pmol/kg/min)
Experimental: Saline
A graded glucose infusion together with a continuous infusion of saline
 Drug: Saline
continuous infusion of saline

  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 og kidney function
  • Haemoglobin below the lower limit
  • Macroalbuminuria
  • Systemic disease
  • Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00612625

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, Patricia Verdugo Højberg
ClinicalTrials.gov Identifier: NCT00612625     History of Changes
Other Study ID Numbers: KF 01 - 198/03, KA 01 - 198/03
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
Glucagon
Glucagon-Like Peptide 1
 Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Incretins

ClinicalTrials.gov processed this record on May 16, 2013