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

Primary Purpose

Diabetes Mellitus Type 2

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
glucagon-like peptide-1
Saline
Sponsored by
Hvidovre University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. of Endocrinology, Hvidovre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GLP-1

Saline

Arm Description

A graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min)

A graded glucose infusion together with a continuous infusion of saline

Outcomes

Primary Outcome Measures

insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min

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

Full Information

First Posted
January 16, 2008
Last Updated
February 11, 2008
Sponsor
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00612625
Brief Title
Near Normalisation of BG Improves the Potentiating Effect of GLP-1
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 Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
July 2004 (Actual)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLP-1
Arm Type
Experimental
Arm Description
A graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min)
Arm Title
Saline
Arm Type
Experimental
Arm Description
A graded glucose infusion together with a continuous infusion of saline
Intervention Type
Drug
Intervention Name(s)
glucagon-like peptide-1
Intervention Description
continuous infusion of GLP-1 (1½ pmol/kg/min)
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
continuous infusion of saline
Primary Outcome Measure Information:
Title
insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia V Højberg, MD, PHD
Organizational Affiliation
University Hospital Hvidovre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Endocrinology, Hvidovre Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
18292985
Citation
Hojberg PV, Zander M, Vilsboll T, Knop FK, Krarup T, Volund A, Holst JJ, Madsbad S. Near normalisation of blood glucose improves the potentiating effect of GLP-1 on glucose-induced insulin secretion in patients with type 2 diabetes. Diabetologia. 2008 Apr;51(4):632-40. doi: 10.1007/s00125-008-0943-x. Epub 2008 Feb 22.
Results Reference
derived

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

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