Hypoglycemia
Conditions
Brief summary
Investigation of Glucose-dependent Insulinotropic Polypeptide (GIP) effects at hyper and hypoglycemia in type 1 diabetes.
Interventions
Sponsors
University of Copenhagen
Mikkel Christensen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
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) * Anemia * treatment with medication not applicable to pause for 12 hours * C-peptide increase after 50 g iv arginine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma glucagon area under curve values | approx. 15 minutes intervals, time 0 to 120 min |
Secondary
| Measure | Time frame |
|---|---|
| plasma gut hormones and nutrients (absolute, incremental and area under curve values) | approx. 15 minutes intervals, time 0 to 120 min |
Other
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed