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

NCT01265121 | Unknown

• 1 other identifier: FAPESP 2008/10045-3
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly; Obstructive Sleep Apnea; Insulin Resistance

Keywords

Acromegaly; Insulin resistance; Euglycemic Clamp; Somatostatin analogues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assess lipids profile and weight

  At the beginning of the study and after 90 days.

Study Arms (2)

CPAP treatment

EXPERIMENTAL

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)

Nasal adhesive

PLACEBO COMPARATOR

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

Other: External nasal dilator adhesive

Interventions

Continuous positive air pressure device (CPAP) DEVICE

After titrating the air pressure during a polysomnography test, a CPAP device will be applied to the patient, during the night, for three months.

CPAP treatment

External nasal dilator adhesive OTHER

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.

Also known as: Clear Passage (™) External nasal dilator adhesive

Nasal adhesive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acromegalic patients
• Moderate to severe sleep apnea
• Using somatostatin analogues at maximum dosage possible for at least 6 month

You may not qualify if:

• Unstable angina or high risk for stroke
• Hepatic or renal insufficiency
• Uncontrolled diabetes
• Seizures
• Steroids use
• Uncontrolled hormonal deficiencies

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• InCor Heart Institute: collaborator

Study Sites (1)

General Hospital of the University of São Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 22666791 DERIVED

MeSH Terms

Conditions

Acromegaly; Sleep Apnea, Obstructive; Insulin Resistance

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Felipe HG Duarte, MD

  Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 22, 2010
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 22, 2010

Record last verified: 2010-11

Locations

BR (1)