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Comparison of orlistat treatment and placebo in obese type 2 diabetic patients.

AbstractAIM:
To evaluate the effects of 1-year treatment with orlistat compared with placebo on different inflammatory parameters in type 2 obese diabetic patients.
MATERIALS AND METHODS:
Two hundred and fifty-four type 2 diabetic patients were randomized to take orlistat 120 mg three times a day or placebo for 12 months. We evaluated at baseline and after 3, 6, 9 and 12 months: leptin, tumor necrosis factor (TNF)-alpha, adiponectin (ADN), vaspin and high-sensitivity C-reactive protein (HS-CRP), body weight, waist circumference, body mass index (BMI), lipid profile, glycemic profile, fasting plasma insulin (FPI) and homeostasis model assessment insulin resistance index (HOMA-IR).
RESULTS:
Regarding inflammatory parameters, there was a significant improvement of ADN and TNF-alpha, and a faster decrease of leptin and HS-CRP in the orlistat group compared with the control group. We also recorded a significant reduction of body weight and BMI with orlistat, but not with placebo. A faster improvement of glycemic profile and FPI was obtained with orlistat compared with the controls. Also, there was a significant reduction of lipid profile with orlistat, not reached with placebo.
CONCLUSIONS:
Orlistat was more effective than placebo in ameliorating inflammatory parameters such as ADN and TNF-alpha, and anthropometric parameters.
AuthorsGiuseppe Derosa, Pamela Maffioli, Sibilla A T Salvadeo, Ilaria Ferrari, Alessia Gravina, Roberto Mereu, Angela D'Angelo, Elena Fogari, Ilaria Palumbo, Sabrina Randazzo, Arrigo F G Cicero
JournalExpert opinion on pharmacotherapy (Expert Opin Pharmacother) Vol. 11 Issue 12 Pg. 1971-82 (08 2010) ISSN: 1744-7666 [Electronic] England
PMID20569086 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • ADIPOQ protein, human
  • Adiponectin
  • Anti-Obesity Agents
  • Biomarkers
  • Blood Glucose
  • Hypoglycemic Agents
  • Inflammation Mediators
  • Insulin
  • Lactones
  • Leptin
  • Lipids
  • SERPINA12 protein, human
  • Serpins
  • Tumor Necrosis Factor-alpha
  • C-Reactive Protein
  • Orlistat
Topics
  • Adiponectin (blood)
  • Anti-Obesity Agents (adverse effects, therapeutic use)
  • Biomarkers (blood)
  • Blood Glucose (metabolism)
  • Body Mass Index
  • Body Weight
  • C-Reactive Protein (metabolism)
  • Diabetes Mellitus, Type 2 (drug therapy, immunology, metabolism, physiopathology)
  • Double-Blind Method
  • Female
  • Humans
  • Hypoglycemic Agents (therapeutic use)
  • Inflammation Mediators (blood)
  • Insulin (blood)
  • Insulin Resistance
  • Italy
  • Lactones (adverse effects, therapeutic use)
  • Leptin (blood)
  • Lipids (blood)
  • Male
  • Middle Aged
  • Obesity (drug therapy, immunology, metabolism, physiopathology)
  • Orlistat
  • Placebo Effect
  • Serpins (blood)
  • Time Factors
  • Treatment Outcome
  • Tumor Necrosis Factor-alpha (blood)
  • Waist Circumference

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