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1 coronary risk factor?
Design
Randomised (unclear allocation concealment*), blinded (patients, outcome assessors),* placebo controlled trial with 1 year follow up.
Setting
33 primary care centres in Sweden.
Patients
376 patients between 18 and 75 years of age (mean age 53 y, 64% women) who had a body mass index between 28 and 38 kg/m2. Patients had to have
1 of the following: fasting serum glucose concentration
6.7 mmol/l or type-2 diabetes mellitus treated with sulfonylurea or metformin (not insulin); cholesterol concentration
6.5 mmol/l or low density lipoprotein (LDL) cholesterol concentration
4.2 mmol/l on
2 occasions, or lipid lowering medication; or diastolic blood pressure concentration
90 mm Hg on
2 occasions or on hypertension treatment. Exclusion criteria were lactation, pregnancy, or not using adequate contraception; recent myocardial infarction; gastrointestinal surgery for weight reduction; gastrointestinal disorders; pancreatic disease; history of postsurgical adhesions; excessive alcohol intake; substance abuse; or use of systemic steroids or weight or lipid
Paul D Levinson, MD
Memorial Hospital of Rhode Island Pawtucket, Rhode Island, USA
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