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

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Acromegaly
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Novartis Pharmaceuticals – Acromegaly
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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