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

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Insulin Resistance; Acromegaly; Obstructive Sleep Apnea

Treatments: Device: Continuous positive air pressure device (CPAP); Other: External nasal dilator adhesive

Study type: Interventional

Funder types: Other

Identifiers

NCT01265121

FAPESP 2008/10045-3

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups, including a placebo group

CPAP treatment

Experimental group

Description:

This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP)

Treatment:

Device: Continuous positive air pressure device (CPAP)

Nasal adhesive

Placebo Comparator group

Description:

This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment

Treatment:

Other: External nasal dilator adhesive