Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01265121|
Recruitment Status : Unknown
Verified November 2010 by University of Sao Paulo General Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 22, 2010
Last Update Posted : December 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Acromegaly Obstructive Sleep Apnea Insulin Resistance||Device: Continuous positive air pressure device (CPAP) Other: External nasal dilator adhesive||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||June 2011|
Experimental: 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)
Device: 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.
Placebo Comparator: Nasal adhesive
This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment
Other: 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.
Other Name: Clear Passage (™) External nasal dilator adhesive
- 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.
- Assess lipids profile and weight [ Time Frame: At the beginning of the study and after 90 days. ]Lipids and weight will be assessed durind the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265121
|General Hospital of the University of São Paulo|
|São Paulo, Brazil, 05403-000|
|Principal Investigator:||Felipe HG Duarte, MD||Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo|