Beta-Cell Function After Near-Normalisation of Blood Glucose
Four Weeks of Near Normalisation of Blood Glucose Improves the Insulin Response to GLP-1 and GIP in Patients With Type 2 Diabetes
1 other identifier
interventional
8
1 country
1
Brief Summary
The incretin effect is attenuated in patients with type 2 diabetes mellitus partly due to impaired potentiation of beta-cell responsiveness to glucose by glucose dependent insulinotropic polypeptide and glucagon-like peptide-1 respectively. The aim of the present study was to investigate whether 4 weeks of near-normalization of blood glucose could improve the insulin responses to GIP and GLP-1 in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable type-2-diabetes
Started Oct 2006
Shorter than P25 for not_applicable type-2-diabetes
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
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2007
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
4 months
January 16, 2008
February 11, 2008
Conditions
Outcome Measures
Primary Outcomes (1)
2.phase insulin response measured as incremental area under the curve from 10-120 minutes
2 hours
Secondary Outcomes (1)
2.phase insulin response measured as incremental area under the curve from 10-120 minutes, after 4 weeks of insulin treatment
2 hours
Study Arms (3)
GLP-1
EXPERIMENTALGIP
EXPERIMENTALsaline
PLACEBO COMPARATORInterventions
GLP-1:continuous infusion of ½ pmol/kg/min for a total time of 120 minutes.
continuous infusion of GIP (1½ pmol/kg/min) for 120 min.
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 and 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, Vilsboll T, Rabol R, Knop FK, Bache M, Krarup T, Holst JJ, Madsbad S. Four weeks of near-normalisation of blood glucose improves the insulin response to glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide in patients with type 2 diabetes. Diabetologia. 2009 Feb;52(2):199-207. doi: 10.1007/s00125-008-1195-5. Epub 2008 Nov 27.
PMID: 19037628DERIVED
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
October 1, 2006
Primary Completion
February 1, 2007
Study Completion
May 1, 2007
Last Updated
February 12, 2008
Record last verified: 2008-01