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Clinical Trials/ISRCTN70090382
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.

Registry
who.int
Start Date
February 13, 2009
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Cambridge Manufacturing Company Limited (UK)

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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