Type 1 DiabetesNCT01116180
Cognitive Function and Electrocardiogram (ECG) During Hypoglycemia and Blockade of the Renin-angiotensin System
A study testing Angiotensin II receptor antagonists (Candesartan) in people with Type 1 Diabetes and Hypoglycemia, run by Louise Faerch at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Angiotensin II receptor antagonists (Candesartan)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes
- Danish spoken and written
- RAS activity score>7 - diabetes duration > 5 years
- not pregnant and safe anticonception
- Signed informed consent.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiology and Endocrinology, Hillerød Hospital
Hillerød, 3400
About this study
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
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.
Read the 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
- Being tested
- Angiotensin II receptor antagonists (Candesartan), Placebo
- Keywords
- Type 1 diabetes, Hypoglycaemia, genetic susceptibility, Renin angiotensin system activity
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II receptor antagonists (Candesartan)Drug
Also called Blopress, Atacand, Amias, Ratacand
Seven days of treatment with Candesartan 32 mg, capsules.
PlaceboDrug
Placebo Capsule matching the active comparator. Given for 7 days once daily.
| Study group | Role | What they receive |
|---|---|---|
| Candesartan | Active comparator | Not described Receives: Drug: Angiotensin II receptor antagonists (Candesartan) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function and brain cortical activity assessed by EEG
Measured: 2 month
Secondary outcomes (4)
Symptoms of hypoglycaemia assessed by Edinburgh Hypoglycaemia Symptom Score questionnaire
Measured: 2 month
Hormonal counter-regulatory response and substrates
Measured: 2 month
Blood pressure and pulse
Measured: 2 month
Cardiac conduction evaluated by a three channel digital Holter Monitor.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louise Faerch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Louise Faerch, Hillerod Hospital, Denmark
- Investigators
- Ulrik Pedersen-Bjergaard, MD, MDSc., Study director, Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 HillerødLouise Færch, MD, Principal investigator, Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 HillerødBirger Thorsteinsson, Prof DMSc MD, Study director, Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød. University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116180
- Sponsor's protocol ID
- HypoRas
- Status last verified
- Feb 2013
- First submitted
- 25 Jan 2010
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01116180
- Acronym / sponsor ID
- HypoRas
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Type 1 diabetes, Hypoglycaemia, genetic susceptibility, Renin angiotensin system activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Louise FaerchUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Candesartan | Active comparator | Drug: Angiotensin II receptor antagonists (Candesartan) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 1 diabetes
- Danish spoken and written
- RAS activity score>7 - diabetes duration > 5 years
- not pregnant and safe anticonception
- Signed informed consent.
Key exclusion criteria (13 listed)
- Treatment with an ACE blocker
- An ARB og a renin blocker
- Treatment with other antihypertensive drugs
- Severe diabetic late complications
- Renal impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin II receptor antagonists (Candesartan)Also: Blopress, Atacand, Amias, RatacandSeven days of treatment with Candesartan 32 mg, capsules. | Drug | Candesartan |
| PlaceboPlacebo Capsule matching the active comparator. Given for 7 days once daily. | Drug | Placebo |
Primary outcome
Cognitive function and brain cortical activity assessed by EEG
Time frame: 2 month
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulrik Pedersen-Bjergaard, MD, MDSc. study director
Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød
Louise Færch, MD principal investigator
Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød
Birger Thorsteinsson, Prof DMSc MD study director
Hillerød Hospital, Department of Cardiology and Endocrinology, Dyrehavevej 29, 3400 Hillerød. University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Angiotensin II receptor antagonists (Candesartan) in people with Type 1 Diabetes and Hypoglycemia, run by Louise Faerch at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive function and brain cortical activity assessed by EEG (time frame: 2 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2013.