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

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ClinicalTrials.gov Identifier: NCT01265121
Recruitment Status : Unknown
Verified November 2010 by University of Sao Paulo General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : December 22, 2010
Last Update Posted : December 22, 2010
Sponsor:
Collaborator:
InCor Heart Institute
Information provided by:
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.

Condition or disease Intervention/treatment
Acromegaly Obstructive Sleep Apnea Insulin Resistance Device: Continuous positive air pressure device (CPAP) Other: External nasal dilator adhesive

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Study Start Date : September 2009
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CPAP treatment
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)
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: Nasal adhesive
This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment
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.
Other Name: Clear Passage (™) External nasal dilator adhesive



Primary Outcome Measures :
  1. Assess the insulin resistance [ Time Frame: 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 :
  1. Assess lipids profile and weight [ Time Frame: At the beginning of the study and after 90 days. ]
    Lipids and weight will be assessed durind the study



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265121


Locations
Brazil
General Hospital of the University of São Paulo
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
InCor Heart Institute
Investigators
Principal Investigator: Felipe HG Duarte, MD Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Felipe Henning Gaia Duarte, MD, Unit of Neuroendocrinology, discipline of endocrinology, University of São Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01265121     History of Changes
Other Study ID Numbers: FAPESP 2008/10045-3
First Posted: December 22, 2010    Key Record Dates
Last Update Posted: December 22, 2010
Last Verified: November 2010

Keywords provided by University of Sao Paulo General Hospital:
Acromegaly
Insulin resistance
Euglycemic Clamp
Somatostatin analogues

Additional relevant MeSH terms:
Acromegaly
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Insulin Resistance
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases