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

Not Applicable

• Conditions: Acromegaly; Obstructive Sleep Apnea; Insulin Resistance
• Interventions: Device: Continuous positive air pressure device (CPAP); Other: External nasal dilator adhesive

• Registration Number: NCT01265121
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-11
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-21
• Last Update Submitted: 2010-12-21
• Study First Posted: 2010-12-22
• Last Update Posted: 2010-12-22
• Primary Completion: 2011-04
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP treatment	Continuous positive air pressure device (CPAP)	This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP)
Nasal adhesive	External nasal dilator adhesive	This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment

Primary Outcome Measures

Name	Time	Method
Assess the insulin resistance	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.

Secondary Outcome Measures

Name	Time	Method
Assess lipids profile and weight	At the beginning of the study and after 90 days.	Lipids and weight will be assessed durind the study

Trial Locations

Locations (1)

General Hospital of the University of São Paulo; 🇧🇷 São Paulo, Brazil