AcromegalyNCT01265121
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
A study testing Continuous positive air pressure device (CPAP) and External nasal dilator adhesive in people with Acromegaly and Obstructive Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acromegaly, Obstructive Sleep Apnea, Insulin Resistance
- What is being tested?
- Continuous positive air pressure device (CPAP) and External nasal dilator adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Jun 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acromegalic patients
- Moderate to severe sleep apnea
- Using somatostatin analogues at maximum dosage possible for at least 6 month
Who cannot join
- Unstable angina or high risk for stroke
- Hepatic or renal insufficiency
- Uncontrolled diabetes
- Seizures
- Steroids use
- Uncontrolled hormonal deficiencies
Trial locations and contacts
1 site in 1 country.
Brazil1 site
General Hospital of the University of São Paulo
São Paulo, São Paulo, 05403-000
About this study
Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure device (CPAP), on the insulin resistance.
- Conditions
- Acromegaly, Obstructive Sleep Apnea, Insulin Resistance
- Being tested
- Continuous positive air pressure device (CPAP), External nasal dilator adhesive
- Keywords
- Acromegaly, Insulin resistance, Euglycemic Clamp, Somatostatin analogues
- Medical subject headings
- Acromegaly, Sleep Apnea, Obstructive, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous positive air pressure device (CPAP)Device
After titrating the air pressure during a polysomnography test, a CPAP device will be applied to the patient, during the night, for three months.
External nasal dilator adhesiveOther
Also called Clear Passage (™) External nasal dilator adhesive
An external nasal dilator adhesive will be given to patients. They will be applied on the nose and will be used for three months aiming to serve as a placebo for snoring and sleep apnea.
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP) Receives: Device: Continuous positive air pressure device (CPAP) |
| Nasal adhesive | Placebo comparator | This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment Receives: Other: External nasal dilator adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the insulin resistance
The insulin resistance, the target of this study, will be assessed by an index obtained during the euglucaemic hyperinsulinemic clamp (EHC). This index is derived from the amount of glucose delivered to the patient during a determined period of time. The (EHC) will be performed at the beginning of the study and 90 days after the intervention.
Measured: At the beginning of the study and after 90 days.
Secondary outcomes (1)
Assess lipids profile and weight
Lipids and weight will be assessed durind the study
Measured: At the beginning of the study and after 90 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startSep 2009
- Primary completionApr 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Investigators
- Felipe HG Duarte, MD, Principal investigator, Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265121
- Sponsor's protocol ID
- FAPESP 2008/10045-3
- Status last verified
- Nov 2010
- First submitted
- 13 Dec 2010
- Last updated
- 22 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Amaro AC, Duarte FH, Jallad RS, Bronstein MD, Redline S, Lorenzi-Filho G. The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure. Clinics (Sao Paulo). 2012;67(5):469-74. doi: 10.6061/clinics/2012(05)11.
PubMed 22666791
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
- ClinicalTrials.gov ID
- NCT01265121
- Acronym / sponsor ID
- FAPESP 2008/10045-3
- Conditions
- Acromegaly, Obstructive Sleep Apnea, Insulin Resistance
- Keywords
- Acromegaly, Insulin resistance, Euglycemic Clamp, Somatostatin analogues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 22 Dec 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.
Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure device (CPAP), on the insulin resistance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: Continuous positive air pressure device (CPAP)This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP) |
| Nasal adhesive | Placebo comparator | Other: External nasal dilator adhesiveThis acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Acromegalic patients
- Moderate to severe sleep apnea
- Using somatostatin analogues at maximum dosage possible for at least 6 month
Key exclusion criteria (6 listed)
- Unstable angina or high risk for stroke
- Hepatic or renal insufficiency
- Uncontrolled diabetes
- Seizures
- Steroids use
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 |
|---|---|---|
| Continuous positive air pressure device (CPAP)After titrating the air pressure during a polysomnography test, a CPAP device will be applied to the patient, during the night, for three months. | Device | CPAP treatment |
| External nasal dilator adhesiveAlso: Clear Passage (™) External nasal dilator adhesiveAn external nasal dilator adhesive will be given to patients. They will be applied on the nose and will be used for three months aiming to serve as a placebo for snoring and sleep apnea. | Other | Nasal adhesive |
Primary outcome
Assess the insulin resistance
Time frame: At the beginning of the study and after 90 days.
The insulin resistance, the target of this study, will be assessed by an index obtained during the euglucaemic hyperinsulinemic clamp (EHC). This index is derived from the amount of glucose delivered to the patient during a determined period of time. The (EHC) will be performed at the beginning of the study and 90 days after the intervention.
1 secondary outcome
Assess lipids profile and weight
Time frame: At the beginning of the study and after 90 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2010.
- Derived from this study: PubMed 22666791Amaro AC, Duarte FH, Jallad RS, Bronstein MD, Redline S, Lorenzi-Filho G. The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure. Clinics (Sao Paulo). 2012;67(5):469-74. doi: 10.6061/clinics/2012(05)11.
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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.
Felipe HG Duarte, MD principal investigator
Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous positive air pressure device (CPAP) and External nasal dilator adhesive in people with Acromegaly and Obstructive Sleep Apnea, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Dec 2010. 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 Brazil. 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?
Results are not available in the source record.
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?
Assess the insulin resistance (time frame: At the beginning of the study and after 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265121, which also lists 1 linked publication.
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 22 Dec 2010.