Diabetes Mellitus, Type 1
Conditions
Keywords
diabetes mellitus type 1, hypoglycemia, sulfonylurea, glucagon
Brief summary
We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients with type 1 diabetes when compared to type 1 diabetic patients with residual insulin secretion (C-peptide positive).
Detailed description
The glucagon response during insulin induced hypoglycemia and rate of glucose recovery will be monitored in 10 C-peptide positive and 10 C-Peptide negative patients with type 1 DM following the application of glibenclamide and placebo in a randomized, single-blind, cross-over study. Cognitive function during hypoglycemia with and without glibenclamide pretreatment will be a secondary outcome.
Interventions
DRUGglibenclamide
glibenclamide 15 mg single dose
DRUGplacebo
placebo capsules, single dose
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 to 50 years * Patients diagnosed with C-peptide negative diabetes type 1 (C-peptide \<200 pmol/L 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l) * Patients diagnosed with C-peptide positive diabetes type 1 (C-peptide \> 500 pmol/l 6 min after 1 mg glucagon i.v. at plasma glucose concentrations between 5 and 11 mmol/l) * Stable metabolic control; HbA1c levels \<8.0 % and without episodes of antecedent severe hypoglycemias in the past four weeks
Exclusion criteria
* Patients treated with medications potentially interfering with glucose metabolism, such as systemic steroids, immunosuppressive drugs (cyclosporine, tacrolimus, sirolimus), highly active antiretroviral therapy * History coronary artery disease * History of epilepsy or seizures * Current smokers * Any significant or unstable hepatic, cardiac, pulmonary, renal, neurological, musculoskeletal, hematological or endocrine disease. * Pregnant or breast feeding women * Woman of childbearing potential not using a reliable method of birth control such as oral contraceptives or IUD. * Subjects refusing or unable to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma glucagon concentrations during insulin induced hypoglycemia with and without glibenclamide pretreatment | cross-sectional |
Secondary
| Measure | Time frame |
|---|---|
| rate of glucose recovery following insulin induced hypoglycemia with and without glibenclamide pretreatment | cross-sectional |
| cognitive function during insulin induced hypoglycemia with and without glibenclamide pretreatment | cross-sectional |
Countries
Switzerland
Outcome results
None listed