Type 2 Diabetes
Conditions
Keywords
Diabetes, Hypoglycemia
Brief summary
The aim of this study is to establish the risk and frequency of non-symptomatic hypoglycemia in type 2 diabetes under previous therapy with glibenclamide. Participants will be monitored via a continuous glucose monitoring system in a standardized clinical setting during day and night time, implementing meals and exercise of moderate intensity performed in the postprandial state.
Detailed description
The day-to-day change of blood glucose is associated with the frequency of vascular complications and the quality of life of diabetic patients. In this study the frequency of hypoglycemic events in combination with postprandial hyperglycemia in type 2 diabetic patients on oral insulinotropic therapy will be observed. Using more sophisticated technology than before the probability of type 2 diabetic patients on glibenclamide to experience hypoglycemic episodes will be registered. Hypoglycemia is prone to cardiovascular complications in type 2 diabetic patients due to concomitant dysregulation of blood flow. With standardized test meals followed by exercise in a clinical setting hormonal counterregulation and cardiovascular parameters associated with hypoglycemia will be identified. The acute effect of different conditions of exercise and a single dose of either glibenclamide or placebo will be followed each day during the total three-day observation period. Thus we will evaluate the frequency of and the risk factors associated with hypoglycemia and meal-related hyperglycemia in type 2 diabetic patients.
Interventions
DRUGGlibenclamide
Taking a single dose of 3.5 mg glibenclamide
Sponsors
Merck Sharp & Dohme LLC
University of Giessen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes on glibenclamide with or without * Glycated hemoglobin ≤ 7.5% * Stable dosage for three weeks
Exclusion criteria
* HbA1c \> 7.5% * Fasting C-peptide below normal * Concurrent infectious disease * Pregnancy * Malignant disease * Inability to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of hypoglycemic events | 3 days |
Secondary
| Measure | Time frame |
|---|---|
| Secretion of hormones increasing blood glucose, effect of exercise on hypoglycemic events, postprandial glucose excursions, heart rate and forearm blood flow at hypoglycemia | 3 days |
Outcome results
None listed