GIP and GLP-1 in Type 1 Diabetes
1 other identifier
interventional
10
1 country
1
Brief Summary
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 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
Started Jul 2012
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, 2012
CompletedFirst Submitted
Initial submission to the registry
November 17, 2012
CompletedFirst Posted
Study publicly available on registry
December 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedJuly 13, 2015
July 1, 2015
9 months
November 17, 2012
July 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
plasma glucagon area under curve values
approx. 15 minutes intervals, time 0 to 120 min
Secondary Outcomes (1)
plasma gut hormones and nutrients (absolute, incremental and area under curve values)
approx. 15 minutes intervals, time 0 to 120 min
Other Outcomes (2)
Glucose and glycerol tracer kinetics
approx. 15 minutes intervals, time 0 to 120 min
glucose (g/kg body weight) needed to be infuse to keep clamp
approx. 15 minutes intervals, time 0 to 120 min
Study Arms (2)
hyperglycemia
EXPERIMENTALHyperglycemic clamping
hypoglycemia
EXPERIMENTALHypoglycemic clamping
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with type 1 diabetes (WHO criteria)
You may not qualify if:
- HbA1c \> 9 %
- Liver disease (ALAT/ASAT \> 2 x upper normal limit)
- Diabetic nephropathy (s-creatinine \> 130 µM or albuminuria)
- Proliferative diabetic retinopathy (anamnestic)
- Severe arteriosclerosis or heart failure (NYHA group III or IV)
- Anemia
- treatment with medication not applicable to pause for 12 hours
- C-peptide increase after 50 g iv arginine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mikkel Christensenlead
- University of Copenhagencollaborator
Study Sites (1)
Gentofte Hospital
Hellerup, 2900, Denmark
Related Publications (1)
Christensen M, Calanna S, Sparre-Ulrich AH, Kristensen PL, Rosenkilde MM, Faber J, Purrello F, van Hall G, Holst JJ, Vilsboll T, Knop FK. Glucose-dependent insulinotropic polypeptide augments glucagon responses to hypoglycemia in type 1 diabetes. Diabetes. 2015 Jan;64(1):72-8. doi: 10.2337/db14-0440. Epub 2014 Jul 22.
PMID: 25053587DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mikkel Christensen, MD
University Hospital, Gentofte, Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
November 17, 2012
First Posted
December 3, 2012
Study Start
July 1, 2012
Primary Completion
April 1, 2013
Study Completion
November 1, 2013
Last Updated
July 13, 2015
Record last verified: 2015-07