Risk of Hypoglycemia in Type 2 Diabetes
Information source: University of Giessen
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes
Intervention: Glibenclamide (Drug)
Phase: N/A
Status: Active, not recruiting
Sponsored by: University of Giessen
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.
Clinical Details
Official title: Risk of Hypoglycemia in Type 2 Diabetes - Effects of Glibenclamide and Exercise on Cardiovascular, Hormonal, and Metabolic Parameters
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Number of hypoglycemic events
Secondary outcome: Secretion of hormones increasing blood glucose, effect of exercise on hypoglycemic events, postprandial glucose excursions, heart rate and forearm blood flow at hypoglycemia
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: July 2008
Last updated: August 13, 2008
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