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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acromegaly, Obstructive Sleep Apnea, Insulin Resistance

Intervention / Treatment
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* Device: Continuous positive air pressure device (CPAP)
* Other: External nasal dilator adhesive


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP treatment<br>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)<br>* After titrating the air pressure during a polysomnography test, a CPAP device will be applied to the patient, during the night, for three months.<br>|
| Placebo Comparator: Nasal adhesive<br>This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment | Other: External nasal dilator adhesive<br>* 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.<br>* Other names: Clear Passage (™) External nasal dilator adhesive;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess lipids profile and weight | Lipids and weight will be assessed durind the study | At the beginning of the study and after 90 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acromegaly, Insulin resistance, Euglycemic Clamp, Somatostatin analogues