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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01265121
• Other study ID #: FAPESP 2008/10045-3
• Status: Active, not recruiting
• Phase: N/A
• First received: December 13, 2010
• Last updated: December 21, 2010
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2010
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: ANVISA, National Agency for Sanitary Surveillance - Agência Nacional de Vigilância Sanitária
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acromegaly
• Apnea
• Insulin Resistance
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

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.

Locations

Country	Name	City	State
Brazil	General Hospital of the University of São Paulo	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	InCor Heart Institute

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the insulin resistance	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.	No
Secondary	Assess lipids profile and weight	Lipids and weight will be assessed durind the study	At the beginning of the study and after 90 days.	No