Active Ingredient: Orlistat
Vitamin A retinol was determined using a liquid-chromatographic assay 40. Vitamin E tocopherol and vitamin K phylloquinone were determined by HPLC using post-column chemical reduction and fluorimetric detection 42, 43.
Total and undercarboxylated osteocalcin were determined by RIA as described by Gundberg, et al 44. A 24-hr urine was collected for measurement of calcium, phosphorus, creatinine, and oxalate excretion.
A 72-hour stool, whose beginning and end were detected by having subjects ingest methylene blue dye 45, was collected for measurement of fecal fat excretion.
This analysis was performed as previously described by Mayo Medical Laboratories 46. Gallbladder and renal ultrasound were obtained by standard methodology on all subjects. Dextrose. Blood samples were collected through a second intravenous line for glucose and insulin at 2, 4, 6, 10, 14, 19, 22, 24, 27, 30, 35, 40, 45, 50, 70, 90, 120, 150, 180, 210, 240, 270, and 300 minutes, and for C-peptide at 120 minute intervals.
Insulin sensitivity and glucose effectiveness were assessed according to Bergman's minimal model 47 using the SAAM II program version 1. Monitoring of adverse events Subjects were queried weekly about adverse events for the first 12 weeks, and monthly thereafter, with particular attention directed toward the expected gastrointestinal effects of orlistat.
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