Near Normalisation of BG Improves the Potentiating Effect of GLP-1
Near Normalisation of Blood Glucose Improves the Potentiating Effect of GLP-1 on Glucose Induced Insulin Secretion in Patients With Type 2 Diabetes
2 other identifiers
interventional
9
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable diabetes-mellitus-type-2
Started Feb 2004
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
January 16, 2008
CompletedFirst Posted
Study publicly available on registry
February 12, 2008
CompletedFebruary 12, 2008
January 1, 2008
5 months
January 16, 2008
February 11, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
insulin secretion rate (ISR) were derived by deconvolution of c-peptide. ISR is expressed as pmol/kg/min
180 minutes
Secondary Outcomes (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
180 minutes
Study Arms (2)
GLP-1
EXPERIMENTALA graded glucose infusion with an infusion of GLP-1 (1½ pmol/kg/min)
Saline
EXPERIMENTALA graded glucose infusion together with a continuous infusion of saline
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-70 years
- Type 2 diabetes diagnosed after 30 years of age
- BMI \> 25
You may not qualify if:
- Severe complications to diabetes
- Abnormal liver og kidney function
- Haemoglobin below the lower limit
- Macroalbuminuria
- Systemic disease
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dept. of Endocrinology, Hvidovre Hospital
Copenhagen, Denmark
Related Publications (1)
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.
PMID: 18292985DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patricia V Højberg, MD, PHD
University Hospital Hvidovre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 16, 2008
First Posted
February 12, 2008
Study Start
February 1, 2004
Primary Completion
July 1, 2004
Study Completion
December 1, 2004
Last Updated
February 12, 2008
Record last verified: 2008-01