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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01265121

Enrollment

Registered

2010-12-22

Start date

2009-09-30

Completion date

2011-06-30

Last updated

2010-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acromegaly, Insulin Resistance, Obstructive Sleep Apnea

Keywords

Acromegaly, Insulin resistance, Euglycemic Clamp, Somatostatin analogues

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.

Interventions

DEVICEContinuous 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.

OTHERExternal 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assess the insulin resistance	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

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026