Cognitive Function and Electrocardiogram (ECG) During Hypoglycemia and Blockade of the Renin-angiotensin System

NCT ID: NCT01116180

Last Updated: 2013-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2013-02-28

Brief 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.

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.

Conditions

Type 1 Diabetes; Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Candesartan

Group Type: ACTIVE_COMPARATOR

Angiotensin II receptor antagonists (Candesartan)

Intervention Type: DRUG

Seven days of treatment with Candesartan 32 mg, capsules.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Capsule matching the active comparator. Given for 7 days once daily.

Interventions

Angiotensin II receptor antagonists (Candesartan)

Seven days of treatment with Candesartan 32 mg, capsules.

Intervention Type: DRUG

Placebo

Placebo Capsule matching the active comparator. Given for 7 days once daily.

Intervention Type: DRUG

Other Intervention Names

Blopress; Atacand; Amias; Ratacand

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Louise Faerch

OTHER

Sponsor Role: lead

Responsible Party

Louise Faerch

MD, ph.d.student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ulrik Pedersen-Bjergaard, MD, MDSc.

Role: STUDY_DIRECTOR

Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød

Louise Færch, MD

Role: PRINCIPAL_INVESTIGATOR

Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød

Birger Thorsteinsson, Prof DMSc MD

Role: STUDY_DIRECTOR

Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød. University of Copenhagen

Locations

Department of Cardiology and Endocrinology, Hillerød Hospital

Hillerød, , Denmark

Countries

Denmark

Other Identifiers

HypoRas

Identifier Type: -

Identifier Source: org_study_id