Cognitive Function and Electrocardiogram (ECG) During Hypoglycemia and Blockade of the Renin-angiotensin System
|ClinicalTrials.gov Identifier: NCT01116180|
Recruitment Status : Completed
First Posted : May 4, 2010
Last Update Posted : February 5, 2013
Hypothesis: Treating patients with type 1 diabetes with a certain antihypertensive drug preserve cerebral function during hypoglycaemia.
Background: Studies have found that certain genetic variations leaves a subject with type 1 diabetes more prone to hypoglycaemia. It it thought to be a decline in cognition during hypoglycaemia that leaves them at risk of severe hypoglycaemia. The idea is tha when you suppress the genetic phenotype with a well known antihypertensive drug an improvement in cognition will occur and this will remove the patients tendency to severe hypoglycaemia.
Methods: The investigators want to explore whether the cerebral function is improved during hypoglycaemia in subjects with type 1 diabetes and the above mentioned genetic variation when treated with the antihypertensive drug Candesartan.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Hypoglycemia||Drug: Angiotensin II receptor antagonists (Candesartan) Drug: Placebo||Not Applicable|
We will include 25 type 1 diabetic patients from our outpatient clinic. They are already genotyped from another trial.
Each patient goes through two cycles with hyperinsulinemic glucose clamp induced hypoglycemia. The study is double blinded, randomised and placebocontrolled so the patients receive both Candesartan and placebo but in different cycles.
In each cycle patients will receive either Candesartan or placebo for 7 days. After 8 days patients undergo a hypoglycaemic clamp during which primary and secondary endpoints will be measured.
In the hyperinsulinemic hypoglycaemic clamp the patients will undergo an adjustment period towards euglycaemia. A period of approximately 1 hour of euglycemia, an hour of hypoglycemia and a period of recovery towards euglycemia. In each of these glycemic states primary and secondary outcomes will be measured.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Influence of Blockade of the Renin-angiotensin System for Preservation of Cognitive Function, Hormonal Counter-regulatory Response, Symptomatology and Cardiac Repolarisation During Hypoglycaemia in Patients With Type 1 Diabetes|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||February 2013|
|Active Comparator: Candesartan||
Drug: Angiotensin II receptor antagonists (Candesartan)
Seven days of treatment with Candesartan 32 mg, capsules.
|Placebo Comparator: Placebo||
Placebo Capsule matching the active comparator. Given for 7 days once daily.
- Cognitive function and brain cortical activity assessed by EEG [ Time Frame: 2 month ]
- Symptoms of hypoglycaemia assessed by Edinburgh Hypoglycaemia Symptom Score questionnaire [ Time Frame: 2 month ]
- Hormonal counter-regulatory response and substrates [ Time Frame: 2 month ]
- Blood pressure and pulse [ Time Frame: 2 month ]
- Cardiac conduction evaluated by a three channel digital Holter Monitor. [ Time Frame: 2 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116180
|Department of Cardiology and Endocrinology, Hillerød Hospital|
|Hillerød, Denmark, 3400|
|Study Director:||Ulrik Pedersen-Bjergaard, MD, MDSc.||Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød|
|Principal Investigator:||Louise Færch, MD||Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød|
|Study Director:||Birger Thorsteinsson, Prof DMSc MD||Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød. University of Copenhagen|