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

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. Identifier: NCT00612625
Recruitment Status : Completed
First Posted : February 12, 2008
Last Update Posted : February 12, 2008
Information provided by:
Hvidovre University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: glucagon-like peptide-1 Drug: Saline Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
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
Study Start Date : February 2004
Actual Primary Completion Date : July 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min [ Time Frame: 180 minutes ]

Secondary Outcome Measures :
  1. 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 ]

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

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

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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 identifier (NCT number): NCT00612625

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Patricia Verdugo Højberg, MD, PHD, Patricia Verdugo Højberg Identifier: NCT00612625     History of Changes
Other Study ID Numbers: KF 01 - 198/03
KA 01 - 198/03
First Posted: February 12, 2008    Key Record Dates
Last Update Posted: February 12, 2008
Last Verified: January 2008

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