Addison's DiseaseCANDINCT01452893
Counterregulatory Hormone Production in Adrenal Insufficiency and Diabetes Type I
An observational study of Addison's Disease and Adrenal Insufficiency, run by University of Wuerzburg at 1 site in Germany.
Trial summary
Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Addison's Disease, Adrenal Insufficiency, Diabetes Mellitus Type I
- What is being tested?
- Spiroergometry
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Dec 2013
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Four groups: Patients with Addison's disease alone patients with diabetes mellitus type I alone patients with both, Addison's disease and Diabetes mellitus type I healthy controls
Who may be able to join
- Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with normal adrenal function and normal glucose regulation
- Age ≥ 18 years
- Ability to comply with the study protocol
- Capability to perform spiroergometry
Who cannot join
- Any contraindication for performing spiroergometry according to the guidelines of the German Cardiac Society:
- acute myocardial infarction
- instable angina pectoris
- symptomatic arrhythmia
- severe and symptomatic stenosis of the aortic valve
- decompensated heart failure
Show all 21Show fewer
- acute pulmonary embolism
- Acute myocarditis
- Acute pericarditis
- Acute aortic dissection
- main coronary artery disease
- valvulopathies
- electrolyte disturbance
- arterial hypertension (systolic blood pressure > 200 mm Hg, diastolic BP > 110 mm Hg)
- Tachyarrhythmia or Bradyarrhythmia
- Hypertrophic cardiomyopathy and other forms of obstructive heart disease
- second or third degree atrioventricular block
- Fever
- Diabetes mellitus Type 2
- Diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa)
- Glucocorticoid-pharmacotherapy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Endocrinology and Diabetology, Dept. of Medicine I, University Hospital Wuerzburg
Würzburg, 97080
About this study
Official title: Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I
Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. The study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects.
Read the detailed description
As patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities this study investigates the counter-regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects. Patients will perform ergometer training with an individualized intensity and fulfill cognitive function testing (stroop test and fatigue inventories) before and after strenuous activity.
- Being tested
- Spiroergometry
- Medical subject headings
- Addison Disease, Adrenal Insufficiency, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpiroergometryProcedure or surgery
At visit 1 determination of the individual VO2max (maximal oxygen uptake) by spiroergometry after first testing of cognitive function.
At visit 2: Spiroergometry with 3 min warm up followed by 5 min 50% VO2max and 15 min at the individual respiratory compensation point (RCP).
| Study group | Role | What they receive |
|---|---|---|
| Type I diabetes | Adult patients with diabetes mellitus type I but normal adrenal function Receives: Procedure: Spiroergometry | |
| Addison's disease | Adult patients with Addison's disease Receives: Procedure: Spiroergometry | |
| Type I diabetes and Addison's disease | Patients suffering from both, diabetes mellitus type I and Addison's disease Receives: Procedure: Spiroergometry | |
| healthy controls | healthy controls with normal adrenal function and normal glucose regulation Receives: Procedure: Spiroergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in cognitive function before and after physical stress
study participants are tested with three standardized tests: stroop-task, symptom rating scale and a short term memory test. First testing is performed at visit 1 at rest, the second test at visit 2 after strenuous activity at a bicycle ergometer.
Measured: testing is performed at first visit (baseline, duration 5 min) and second visit (at least 48 hours after visit1). The second test is performed 5 min after strenous activity of 23 min duration, test duration again 5 min)
Secondary outcomes (1)
differences in counterregulatory hormonal response to physical stress
blood samples for determination of blood glucose, catecholamines and other counterregulatory hormones (cortisol, growth hormone) are collected before, during and after physical activity.
Measured: at visit 2, blood sampling over 180 min starting 10 min before spiroergometry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Addison's DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wuerzburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Allolio, University of Wuerzburg
- Investigators
- Bruno Allolio, MD, Study chair, University of WuerzburgStefanie Hahner, MD, Principal investigator, University of Wuerzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01452893
- Sponsor's protocol ID
- CANDI-1
- Acronym
- CANDI
- Status last verified
- Jan 2014
- First submitted
- 29 Sep 2011
- Last updated
- 6 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Counterregulatory Hormone Production and Cognitive Function in Patients With Adrenal Insufficiency and Diabetes Mellitus Type I
- ClinicalTrials.gov ID
- NCT01452893
- Acronym / sponsor ID
- CANDI / CANDI-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of WuerzburgUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 17 Oct 2011 (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.
Patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction. Furthermore, patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities. The study investigates the counter regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects.
Detailed description
As patients with adrenal insufficiency also exhibit an adrenomedullary dysfunction and patients who suffer from both, adrenal insufficiency and type I diabetes more frequently report hypoglycemia, particularly after strenuous activities this study investigates the counter-regulatory hormonal response to physical stress and the impact on cognitive function in subjects with and without Addison's disease, type I diabetes and healthy subjects. Patients will perform ergometer training with an individualized intensity and fulfill cognitive function testing (stroop test and fatigue inventories) before and after strenuous activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Type I diabetes | – | Procedure: SpiroergometryAdult patients with diabetes mellitus type I but normal adrenal function |
| Addison's disease | – | Procedure: SpiroergometryAdult patients with Addison's disease |
| Type I diabetes and Addison's disease | – | Procedure: SpiroergometryPatients suffering from both, diabetes mellitus type I and Addison's disease |
| healthy controls | – | Procedure: Spiroergometryhealthy controls with normal adrenal function and normal glucose regulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Four groups: Patients with Addison's disease alone patients with diabetes mellitus type I alone patients with both, Addison's disease and Diabetes mellitus type I healthy controls
Key inclusion criteria (4 listed)
- Diagnosis of Addison's disease and/or diabetes mellitus type I or healthy control with normal adrenal function and normal glucose regulation
- Age ≥ 18 years
- Ability to comply with the study protocol
- Capability to perform spiroergometry
Key exclusion criteria (21 listed)
- Any contraindication for performing spiroergometry according to the guidelines of the German Cardiac Society:
- Fever
- Diabetes mellitus Type 2
- Diseases or medication influencing the endogenous levels of plasma catecholamines(e. g. pheochromocytoma, paraganglioma, antidepressants, levodopa)
- Glucocorticoid-pharmacotherapy
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 |
|---|---|---|
| SpiroergometryAt visit 1 determination of the individual VO2max (maximal oxygen uptake) by spiroergometry after first testing of cognitive function. At visit 2: Spiroergometry with 3 min warm up followed by 5 min 50% VO2max and 15 min at the individual respiratory compensation point (RCP). | Procedure or surgery | Addison's disease, Type I diabetes, Type I diabetes and Addison's disease, healthy controls |
Primary outcome
difference in cognitive function before and after physical stress
Time frame: testing is performed at first visit (baseline, duration 5 min) and second visit (at least 48 hours after visit1). The second test is performed 5 min after strenous activity of 23 min duration, test duration again 5 min)
study participants are tested with three standardized tests: stroop-task, symptom rating scale and a short term memory test. First testing is performed at visit 1 at rest, the second test at visit 2 after strenuous activity at a bicycle ergometer.
1 secondary outcome
differences in counterregulatory hormonal response to physical stress
Time frame: at visit 2, blood sampling over 180 min starting 10 min before spiroergometry
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 6 Jan 2014.
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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.
Bruno Allolio, MD study chair
University of Wuerzburg
Stefanie Hahner, MD principal investigator
University of Wuerzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addison's Disease and Adrenal Insufficiency, run by University of Wuerzburg at 1 site in Germany.
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 4 inclusion and 21 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 6 Jan 2014. 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 Germany. 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. 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?
difference in cognitive function before and after physical stress (time frame: testing is performed at first visit (baseline, duration 5 min) and second visit (at least 48 hours after visit1). The second test is performed 5 min after strenous activity of 23 min duration, test duration again 5 min)). 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 6 Jan 2014.