| Methods |
Study design: RCTRandomization procedure: NRAllocation concealment: UnclearFollow‐up: 26 weeks |
| Participants |
Country: USA Setting: Academic center; community recruitmentNumber: 39Age: 51Sex: 67Medications: Oral agents or diet; oral agents withdrawn 1 month prior to interventionBL wt: I 99, C 102BL BMI: I 34.0, C 35.9BL GHb: I 8.1, C7.8 |
| Interventions |
Drug: Orlistat Dosage: 120mg tidDuration: 3 monthsDiet: 500 calorie deficit; <=30% fat; activity encouragedComparison: 500 calorie deficit; <=30% fat; activity encouraged |
| Outcomes |
Weight: YBMI: Y>5% loss (%): FBS: YGHb: YCholesterol: YLDL: YHDL: YTG:SBP:DBP:Side effects: Y |
| Notes |
Funding: Roche Laboratories
Abstract/full text: FT
LOCF: No
ITT: Partial
Attrition: 25%
Blinding: Double blind
Blinding pt: Y
Blinding assessor: Unclear
Blinding provider: Unclear
BL comparable: Y |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
