Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Primary Purpose
Acromegaly, Obstructive Sleep Apnea, Insulin Resistance
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Continuous positive air pressure device (CPAP)
External nasal dilator adhesive
Sponsored by
About this trial
This is an interventional supportive care trial for Acromegaly focused on measuring Acromegaly, Insulin resistance, Euglycemic Clamp, Somatostatin analogues
Eligibility 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
Sites / Locations
- General Hospital of the University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CPAP treatment
Nasal adhesive
Arm Description
This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP)
This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Assess lipids profile and weight
Lipids and weight will be assessed durind the study
Full Information
NCT ID
NCT01265121
First Posted
December 13, 2010
Last Updated
December 21, 2010
Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute
1. Study Identification
Unique Protocol Identification Number
NCT01265121
Brief Title
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Official Title
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
InCor Heart Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acromegaly, Obstructive Sleep Apnea, Insulin Resistance
Keywords
Acromegaly, Insulin resistance, Euglycemic Clamp, Somatostatin analogues
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CPAP treatment
Arm Type
Experimental
Arm Description
This acromegalic patients is going to have sleep apnea treated for 3 months with a with a continuous positive air pressure device (CPAP)
Arm Title
Nasal adhesive
Arm Type
Placebo Comparator
Arm Description
This acromegalic patients will be treated will an external nasal dilator adhesive intended to serve as a placebo treatment
Intervention Type
Device
Intervention Name(s)
Continuous positive air pressure device (CPAP)
Intervention Description
After titrating the air pressure during a polysomnography test, a CPAP device will be applied to the patient, during the night, for three months.
Intervention Type
Other
Intervention Name(s)
External nasal dilator adhesive
Other Intervention Name(s)
Clear Passage (™) External nasal dilator adhesive
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assess the insulin resistance
Description
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.
Time Frame
At the beginning of the study and after 90 days.
Secondary Outcome Measure Information:
Title
Assess lipids profile and weight
Description
Lipids and weight will be assessed durind the study
Time Frame
At the beginning of the study and after 90 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe HG Duarte, MD
Organizational Affiliation
Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of the University of São Paulo
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22666791
Citation
Amaro AC, Duarte FH, Jallad RS, Bronstein MD, Redline S, Lorenzi-Filho G. The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure. Clinics (Sao Paulo). 2012;67(5):469-74. doi: 10.6061/clinics/2012(05)11.
Results Reference
derived
Learn more about this trial
Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
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