NCT01739283CompletedNot Applicable
GIP and GLP-1 in Type 1 Diabetes
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mikkel Christensen
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- plasma glucagon area under curve values
Study Overview
Brief Summary
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with type 1 diabetes (WHO criteria)
Exclusion Criteria
- •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)
- •treatment with medication not applicable to pause for 12 hours
- •C-peptide increase after 50 g iv arginine
Arms & Interventions
hypoglycemia
Experimental
Hypoglycemic clamping
Intervention: GLP-1 (Other)
Outcomes
Primary Outcomes
plasma glucagon area under curve values
Time Frame: approx. 15 minutes intervals, time 0 to 120 min
Secondary Outcomes
- plasma gut hormones and nutrients (absolute, incremental and area under curve values)(approx. 15 minutes intervals, time 0 to 120 min)
Investigators
Mikkel Christensen
principal investigator
University Hospital, Gentofte, Copenhagen
Study Sites (2)
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