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ISRCTN
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ISRCTN05118860
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ClinicalTrials.gov identifier
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Public title
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Battle of the Bulge - A randomised study comparing the effect of three dietary approaches on cardiovascular risk in subject with the metabolic syndrome
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0212177254
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Study hypothesis
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To compare the effectiveness of three dietary regimes in improving cardiovascular risk in subjects with the metabolic syndrome.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Nutritional, Metabolic, Endocrine: Metabolic syndrome
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Participants - inclusion criteria
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Males or non-pregnant females fulfilling the criteria for the metabolic syndrome - these include the presence of 3 or more of the following:
1. Abdominal obesity (waist circumference >102cm in men and > 88cm in women
2. Triglyceride level >150mg/Dl
3. HDL cholesterol <40mg/dL for men, <50mg/dL for women
4. Blood pressure >130mm systolic or 85mm diastolic
5. Fasting plasma glucose >6.1mmol/dL
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Participants - exclusion criteria
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1. Recent cardiovascular event ie stroke, myocardial infarction, or pulmonary embolism within past 4 months
2. Ongoing chronic inflammatory condition: vasculitis, ulcers, inflammatory bowel disease, malignant disorder
3. Renal impairment (creatinine >135)
4. Hepatic impairment (ALT or AST> 4x upper limit of normal)
5. On statin therapy for dyslipaemia
6. Poorly controlled diabetes. Type 2 diabetes on insulin therapy. Type 2 diabetes on thiazolidinione.
7. Untreated thyroid disorders - should be stable on thyroid medication for at least 3 months.
8. Known Cushings syndrome
9. On an anorectic agent ie Orlistat, sibutramine - can be given a 4 week washout period
10. Food allergies/intolerance
11. Vegetarian
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Anticipated start date
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01/03/2004
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Anticipated end date
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01/05/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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120 - recruitment is completed as of July 2008.
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Interventions
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Comparison of three dietary approaches.
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Primary outcome measure(s)
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Improving the cardiovascular risks associated with the Metabolic Syndrome has long-term beneficial effects on health and quality of life. Management through dietary lifestyle changes is possibly the healthier option with less chances of side effects or interactions as would be expected through drugs.
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Royal United Hospital Bath NHS Trust (UK)
Diabetes Research Fund
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Trial website
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Publications
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Contact name
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Dr
Rasha
Mukhtar
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Address
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Wolfson Centre
Royal United Hospital
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City/town
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Bath
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Zip/Postcode
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BA1 3NG
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Country
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United Kingdom
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Tel
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+44 01225 428331
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Fax
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+44
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Email
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mpxrm@bath.ac.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2006 Update - Department of Health
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Address
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The Department of Health, Richmond House, 79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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29/09/2006
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Last edited
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06/10/2011
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Date ISRCTN assigned
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29/09/2006
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