Cognitive Function and Electrocardiogram (ECG) During Hypoglycemia and Blockade of the Renin-angiotensin System
Information source: Hillerod Hospital, Denmark
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes; Hypoglycemia
Intervention: Angiotensin II receptor antagonists (Candesartan) (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Louise Faerch Official(s) and/or principal investigator(s): Ulrik Pedersen-Bjergaard, MD, MDSc., Study Director, Affiliation: Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød Louise Færch, MD, Principal Investigator, Affiliation: Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød Birger Thorsteinsson, Prof DMSc MD, Study Director, Affiliation: Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød. University of Copenhagen
Summary
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.
Clinical Details
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 design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Cognitive function and brain cortical activity assessed by EEG
Secondary outcome: Symptoms of hypoglycaemia assessed by Edinburgh Hypoglycaemia Symptom Score questionnaireHormonal counter-regulatory response and substrates Blood pressure and pulse Cardiac conduction evaluated by a three channel digital Holter Monitor.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Type 1 diabetes
- Danish spoken and written
- RAS activity score>7 - diabetes duration > 5 years
- not pregnant and safe anticonception
- Signed informed consent.
Exclusion Criteria:
- Treatment with an ACE blocker
- An ARB og a renin blocker
- Treatment with other antihypertensive drugs
- Severe diabetic late complications
- Renal impairment
- Pregnancy and breastfeeding
- Previous reactions to study medication
- Heart insufficiency (NYHA 3-4)\
- Known ischaemic heart disease
- Epilepsy
- Alcohol and drug abuse
- Suspicion of non-compliance,
- Plasma potassium < 3. 5 mmol/l or >5. 0 mmol/l.
Locations and Contacts
Department of Cardiology and Endocrinology, Hillerød Hospital, Hillerød 3400, Denmark
Additional Information
Starting date: April 2010
Last updated: February 4, 2013
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