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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by University of Sao Paulo General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
InCor Heart Institute
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01265121
First received: December 13, 2010
Last updated: December 21, 2010
Last verified: November 2010
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Assess the insulin resistance [ Time Frame: At the beginning of the study and after 90 days. ] [ Designated as safety issue: No ]
    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:
  • Assess lipids profile and weight [ Time Frame: At the beginning of the study and after 90 days. ] [ Designated as safety issue: No ]
    Lipids and weight will be assessed durind the study


Estimated Enrollment: 12
Study Start Date: September 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Sao Paulo General Hospital

Additional 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
Study First Received: December 13, 2010
Last Updated: December 21, 2010
Health Authority: Brazil: ANVISA, National Agency for Sanitary Surveillance - Agência Nacional de Vigilância Sanitária

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

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

ClinicalTrials.gov processed this record on May 23, 2013