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Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.

NCT ID: NCT01265121

Last Updated: 2010-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acromegaly Obstructive Sleep Apnea Insulin Resistance

Keywords

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Acromegaly Insulin resistance Euglycemic Clamp Somatostatin analogues

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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CPAP treatment

This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP)

Group Type EXPERIMENTAL

Continuous positive air pressure device (CPAP)

Intervention Type 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.

Nasal adhesive

This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment

Group Type PLACEBO_COMPARATOR

External nasal dilator adhesive

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type OTHER

Other Intervention Names

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Clear Passage (™) External nasal dilator adhesive

Eligibility Criteria

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Inclusion Criteria

* Acromegalic patients
* Moderate to severe sleep apnea
* Using somatostatin analogues at maximum dosage possible for at least 6 month

Exclusion Criteria

* Unstable angina or high risk for stroke
* Hepatic or renal insufficiency
* Uncontrolled diabetes
* Seizures
* Steroids use
* Uncontrolled hormonal deficiencies
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InCor Heart Institute

OTHER

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Unit of Neuroendocrinology, discipline of endocrinology, University of São Paulo General Hospital

Principal Investigators

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Felipe HG Duarte, MD

Role: PRINCIPAL_INVESTIGATOR

Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo

Locations

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General Hospital of the University of São Paulo

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 22666791 (View on PubMed)

Other Identifiers

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FAPESP 2008/10045-3

Identifier Type: -

Identifier Source: org_study_id