Comparison of orlistat treatment and placebo in obese type 2 diabetic patients.
To evaluate the effects of 1-year treatment with orlistat compared with placebo on different inflammatory parameters in type 2 obese diabetic patients.



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).



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.



Orlistat was more effective than placebo in ameliorating inflammatory parameters such as ADN and TNF-alpha, and anthropometric parameters.
Derosa
Giuseppe
G
University of Pavia, Department of Internal Medicine and Therapeutics, 27100 Pavia, Italy. giuseppe.derosa@unipv.it
Maffioli
Pamela
P
Salvadeo
Sibilla A T
SA
Ferrari
Ilaria
I
Gravina
Alessia
A
Mereu
Roberto
R
D'Angelo
Angela
A
Fogari
Elena
E
Palumbo
Ilaria
I
Randazzo
Sabrina
S
Cicero
Arrigo F G
AF
D052242:Adiponectin / Q000097:blood; D019440:Anti-Obesity Agents / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D015992:Body Mass Index; D001835:Body Weight; D002097:C-Reactive Protein / Q000378:metabolism; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism / Q000503:physiopathology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D018836:Inflammation Mediators / Q000097:blood*; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D007558:Italy; D007783:Lactones / Q000009:adverse effects / Q000627:therapeutic use*; D020738:Leptin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000276:immunology / Q000378:metabolism / Q000503:physiopathology; D000077403:Orlistat; D015990:Placebo Effect; D015843:Serpins / Q000097:blood; D013997:Time Factors; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000097:blood; D055105:Waist Circumference
C499918:ADIPOQ protein, human; D052242:Adiponectin; D019440:Anti-Obesity Agents; D015415:Biomarkers; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D018836:Inflammation Mediators; D007328:Insulin; D007783:Lactones; D020738:Leptin; D008055:Lipids; C507339:SERPINA12 protein, human; D015843:Serpins; D014409:Tumor Necrosis Factor-alpha; D002097:C-Reactive Protein; D000077403:Orlistat