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

December 21, 2010 updated by: University of Sao Paulo General Hospital
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil, 05403-000
        • General Hospital of the University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Clear Passage (™) External nasal dilator adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the beginning of the study and after 90 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the beginning of the study and after 90 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Collaborators

InCor Heart Institute

Investigators

  • Principal Investigator: Felipe HG Duarte, MD, Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Anticipated)

April 1, 2011

Study Completion (Anticipated)

June 1, 2011

Study Registration Dates

First Submitted

December 13, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (Estimate)

December 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 22, 2010

Last Update Submitted That Met QC Criteria

December 21, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FAPESP 2008/10045-3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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