- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00612625
Near Normalisation of BG Improves the Potentiating Effect of GLP-1
February 11, 2008 updated by: Hvidovre University Hospital
Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Copenhagen, Denmark
- Dept. of Endocrinology, Hvidovre Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GLP-1
A graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min)
|
continuous infusion of GLP-1 (1½ pmol/kg/min)
|
Experimental: Saline
A graded glucose infusion together with a continuous infusion of saline
|
continuous infusion of saline
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min
Time Frame: 180 minutes
|
180 minutes
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
180 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patricia V Højberg, MD, PHD, University Hospital Hvidovre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2004
Primary Completion (Actual)
July 1, 2004
Study Completion (Actual)
December 1, 2004
Study Registration Dates
First Submitted
January 16, 2008
First Submitted That Met QC Criteria
February 11, 2008
First Posted (Estimate)
February 12, 2008
Study Record Updates
Last Update Posted (Estimate)
February 12, 2008
Last Update Submitted That Met QC Criteria
February 11, 2008
Last Verified
January 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KF 01 - 198/03
- KA 01 - 198/03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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