Overview

This trial is active, not recruiting.

Conditions acromegaly, obstructive sleep apnea, insulin resistance
Treatments continuous positive air pressure device (cpap), external nasal dilator adhesive
Sponsor University of Sao Paulo General Hospital
Collaborator InCor Heart Institute
Start date September 2009
End date April 2011
Trial size 12 participants
Trial identifier NCT01265121, FAPESP 2008/10045-3

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP)
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)
This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment
external nasal dilator adhesive Clear Passage (™) 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.

Primary Outcomes

Measure
Assess the insulin resistance
time frame: At the beginning of the study and after 90 days.

Secondary Outcomes

Measure
Assess lipids profile and weight
time frame: At the beginning of the study and after 90 days.

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Principal investigator Felipe HG Duarte, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by University of Sao Paulo General Hospital.