Brief Title
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Official Title
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Brief 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. 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 Type
Interventional
Primary Outcome
Assess the insulin resistance
Secondary Outcome
Assess lipids profile and weight
Condition
Acromegaly
Intervention
Continuous positive air pressure device (CPAP)
Study Arms / Comparison Groups
CPAP treatment
Description: This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
12
Start Date
September 2009
Completion Date
June 2011
Primary Completion Date
April 2011
Eligibility Criteria
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
Gender
All
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Felipe HG Duarte, MD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01265121
Organization ID
FAPESP 2008/10045-3
Study Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute
Study Sponsor
Felipe HG Duarte, MD, Principal Investigator, Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo
Verification Date
November 2010