Insulinotropic Effect of GLP-1 and GIP After Dexamethasone
Loss of Insulinotropic Properties of Glucagon-like Peptide-1 (GLP-1) and Glucose-dependent Insulinotropic Peptide (GIP) After Glucocorticoid Induced Insulin Resistance
1 other identifier
interventional
19
1 country
1
Brief Summary
In this study we examine whether inducing insulin resistance by dexamethasone in healthy volunteers will lead to a decreased insulinotropic effect of the hormones GLP-1 and GIP.
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
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
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 7, 2014
CompletedFirst Posted
Study publicly available on registry
September 10, 2014
CompletedSeptember 10, 2014
September 1, 2014
4.9 years
September 7, 2014
September 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The potentiating effects of GLP-1 on second phase insulin response when clamped at at bloodsugar of 7 mmol/l
After dexamethasone treatment subjects are tested with infusion of GLP-1 during a clamped blood-sugar of 7mmol/l. Their increase in the second phase insulin response is the primary endpoint.
1-3 days after dexamethasone treatment
Secondary Outcomes (3)
First phase insulin response to GLP-1 infusion at 7mmol/l
1-3 days after dexamethasone
First phase insulin response to GIP infusion at 7mmol/l
1-3 days after dexamethasone
Second phase insulin response to GIP infusion at 7mmol/l
1-3 days after dexamethasone treatment
Other Outcomes (1)
Total insulin response to arginine infusion
1-3 days after dexamethasone
Study Arms (1)
Dexamethasone
EXPERIMENTALThis is a before-after study. All subjects are administered dexamethasone 2mg BID for 5 days.
Interventions
Eligibility Criteria
You may qualify if:
- Caucasians above 20 and below 45 years of age
- Normal glucose tolerance as assessed by the WHO criteria
- First degree relative and at least 1 second degree relative with type 2 diabetes
- Normal haemoglobin
- Informed consent
You may not qualify if:
- Liver disease (ALAT/ASAT \> 2 times normal value)
- Kidney disease (S-creatinin \> 130uM and/or albuminuria)
- Heart disease (NYHA II, III or IV)
- Treatment with medicine that cannot be paused
- Pregnancy of breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bispebjerg University Hospital
Copenhagen NV, 2400, Denmark
Related Publications (1)
Eriksen M, Jensen DH, Tribler S, Holst JJ, Madsbad S, Krarup T. Reduction of insulinotropic properties of GLP-1 and GIP after glucocorticoid-induced insulin resistance. Diabetologia. 2015 May;58(5):920-8. doi: 10.1007/s00125-015-3522-y. Epub 2015 Mar 9.
PMID: 25748606DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thure Krarup, dr. med.
Bispebjerg Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 7, 2014
First Posted
September 10, 2014
Study Start
July 1, 2009
Primary Completion
June 1, 2014
Last Updated
September 10, 2014
Record last verified: 2014-09