Effect of the GLP-1 receptor agonist exenatide on impaired awareness of hypoglycemia in type 1 diabetes
- Conditions
- DiabetesImpaired Awareness of Hypoglycemiahypoglycemia unawareness10018424
- Registration Number
- NL-OMON45806
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 13
* Type 1 diabetes, disease duration >1 year
* Age >18 years, * Insulin treatment according to basal-bolus insulin regimen (injections or insulin pump)
* Impaired awareness of hypoglycemia as assessed by a score of 3 or more on the modified Dutch translation of the Clarke questionnaire
* Glycated haemoglobin (HbA1c) *42 mmol/mol (6%) and *75 mmol/mol (9.0%)
* Ability to provide informed consent
* Treatment with incretin-based therapy (DPP-IV inhibitors or GLP-1RAs)
* Known intolerance to GLP-1RAs (including allergy)
* Treatment with glucose-modefying or immune-modefying agents, e.g. prednisolon
* History of cardiovascular disease (e.g. myocardial infarction, stroke, heart failure) or laser coagulation for proliferative retinopathy (past 6 months)
* Proliferative retinopathy
* Symptomatic diabetic neuropathy
* Diabetic nephropathy as reflected by albumin-creatinin ratio >30 mmol/mg or MDRD <60 ml/min/1.73 m2
* History of pancreatitis (acute or chronic) or pancreatic cancer
* Body-mass index <19 or >40 kg/m2
* Blood pressure >160/90 mmHg
* Use of premixed insulin or of long-acting insulin alone
* Total daily insulin dose requirements <20 units unless on pump treatment
* Pregnancy or unwillingness to undertake measures for birth control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Symptom score in response to the hyperinsulinemic hypoglycemic glucose clamp<br /><br>experiment</p><br>
- Secondary Outcome Measures
Name Time Method