ISRCTN70090382
Completed
Not Applicable
Effects of a very low calorie diet (VLCD) induced weight loss on obstructive sleep apnoea syndrome (OSAS): a randomised controlled trial
Cambridge Manufacturing Company Limited (UK)0 sites60 target enrollmentFebruary 13, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cambridge Manufacturing Company Limited (UK)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Amended as of 09/06/2009:
- •The following points of the below inclusion criteria have been amended:
- •1\. Patients with OSAS with an Apnoea\-Hypopnea Index (AHI) greater than or equal to 15
- •3\. Aged between 30 and 65 years
- •All other inclusion criteria remain unaffected.
- •Initial information at time of registration:
- •1\. Patients with OSAS with an Apnoea\-Hypopnea Index (AHI) between 15 and 60
- •2\. Male patients
- •3\. Age between 30 and 60 years
- •4\. Abdominal obesity with a Body Mass Index (BMI) 30\-40 kg/m^2 and waist circumference \>102 cm
Exclusion Criteria
- •1\. Contraindications for VLCD:
- •1\.1\. Coronary thrombosis or myocardial infarct within the last three months
- •1\.2\. Cerebro\-vascular accident within the last three months
- •1\.3\. Unstable ventricular arrhythmias
- •1\.4\. Major surgery or trauma within the last three months
- •1\.5\. Impaired renal or hepatic function
- •1\.6\. Severe depression
- •1\.7\. Use of mono\-amine oxidase inhibitors (MAOIs)as anti\-depressants
- •1\.8\. Anorexia nervosa or bulimia nervosa
- •1\.9\. Porphyria
Outcomes
Primary Outcomes
Not specified
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