NCT01116180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

2.3 years

First QC Date

January 25, 2010

Last Update Submit

February 4, 2013

Conditions

Type 1 DiabetesHypoglycemia

Keywords

Type 1 diabetesHypoglycaemiagenetic susceptibilityRenin angiotensin system activity

Outcome Measures

Primary Outcomes (1)

  • Cognitive function and brain cortical activity assessed by EEG

    2 month

Secondary Outcomes (4)

  • Symptoms of hypoglycaemia assessed by Edinburgh Hypoglycaemia Symptom Score questionnaire

    2 month

  • Hormonal counter-regulatory response and substrates

    2 month

  • Blood pressure and pulse

    2 month

  • Cardiac conduction evaluated by a three channel digital Holter Monitor.

    2 month

Study Arms (2)

Candesartan

ACTIVE COMPARATOR
Drug: Angiotensin II receptor antagonists (Candesartan)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Angiotensin II receptor antagonists (Candesartan)DRUG

Seven days of treatment with Candesartan 32 mg, capsules.

Also known as: Blopress, Atacand, Amias, Ratacand
Candesartan
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 diabetes
  • Danish spoken and written
  • RAS activity score\>7 - diabetes duration \> 5 years
  • not pregnant and safe anticonception
  • Signed informed consent.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology and Endocrinology, Hillerød Hospital

Hillerød, 3400, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1HypoglycemiaGenetic Predisposition to Disease

Interventions

Angiotensin Receptor Antagonistscandesartancandesartan cilexetil

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesDisease SusceptibilityDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Ulrik Pedersen-Bjergaard, MD, MDSc.

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

    STUDY DIRECTOR

  • Louise Færch, MD

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

    PRINCIPAL INVESTIGATOR

  • Birger Thorsteinsson, Prof DMSc MD

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, ph.d.student

Study Record Dates

First Submitted

January 25, 2010

First Posted

May 4, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2012

Study Completion

February 1, 2013

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

DK(1)