Diabetes Mellitus, Type 1, Hypoglycemia
Conditions
Keywords
Hypoglycemia-Associated Autonomic Failure (HAAF)
Brief summary
This study compares the hypoglycemic counter regulatory response in type 1 diabetics and in healthy control subjects with and without antecedent hypoglycemia
Detailed description
Iatrogenic hypoglycemia is one of the main limiting factors for optimal glycemic management of diabetes. It causes recurrent morbidity in most people with type 1 diabetes and in many patients with type 2 diabetes and can be fatal. Episodes of hypoglycemia impair physiologically protective mechanism in subsequent episodes of hypoglycemia. This phenomenon is known as hypoglycemia-associated autonomic failure (HAAF), the clinical syndromes of defective glucose counter regulation and hypoglycemia unawareness.
Interventions
Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
9 diabetic subjects and 9 healthy control subjects will be randomized to undergo either first day 1 + day 2 (two consecutive episode of hypoglycemia) or first day 3 + day 4 (one episode of hypoglycemia).
Eligibility
Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Type 1 diabetics Inclusion Criteria: * More than 5 years of disease duration * HbA1c 42-86 mmol/L * No known HAAF * BMI 22-28 * Written consent
Exclusion criteria
* Other disease than diabetes f.x epilepsy, ischemic heart disease or heart rhythm disturbance * Medication f.x beta-blockade, steroids, psychotropics * Smoking * Drug abuse Control subjects Inclusion Criteria: * BMI 22-28 * Written consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin sensitivity | Day 2 and day 4 (T=60 minutes - T=240 minutes) | Insulin sensitivity before, during hypoglycemia and after recovery from hypoglycemia on day 2 (one episode of hypoglycemia) compared with day 4 (two consecutive episodes of hypoglycemia). Insulin sensitivity is measured as M-value derived from the Glucose Infusion Rate (GIR) during a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hormonal counter regulatory response to hypoglycemia | Day 2 and day 4 (T=0 minutes, T=30, T=40, T=50, T=120, T=130, T=140, T160, T=170, T=180, T=210, T=220, T=230, T=390, T=400 and T=410 | Hormonal counter regulatory response (epinephrine, norepinephrine, glucagon, cortisol, ghrelin etc.) measured regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp |
| Symptoms during hypoglycemia | Day 2 and day 4 (T=0 minutes - T=420 minutes) | Using the Edinburgh Hypoglycemia Scale (symptom scale) we will interview the subjects regularly before, during and after a hyperinsulinemic euglycemic clamp / hyperinsulinemic hypoglycemic clamp |
Countries
Denmark
Outcome results
None listed