Variation of inflammatory parameters after sibutramine treatment compared to placebo in type 2 diabetic patients.
OBJECTIVE
The efficacy of sibutramine has been demonstrated in randomized trials in obese/overweight patients including those with type 2 diabetes mellitus (T2DM). Our objective was to evaluate the effects of 1-year treatment with sibutramine compared to placebo on body weight, glycaemic control, lipid profile, and inflammatory parameters in type 2 diabetic patients.


METHODS
Two hundred and forty-six patients with uncontrolled T2DM [glycated haemoglobin (HbA(1c) ) > 8·0%] in therapy with different oral hypoglycaemic agents or insulin were randomized to take 10 mg of sibutramine or placebo for 12 months. We evaluated at baseline, and after 3, 6, 9, and 12 months these parameters: body weight, body mass index (BMI), HbA(1c) , fasting plasma glucose (FPG), post-prandial plasma glucose (PPG), fasting plasma insulin (FPI), homeostasis model assessment insulin resistance index (HOMA-IR), total cholesterol (TC), low density lipoprotein-cholesterol (LDL-C), high density lipoprotein-cholesterol (HDL-C), triglycerides (Tg), leptin, tumour necrosis factor-α (TNF-α), adiponectin (ADN), vaspin, high sensitivity C-reactive protein (Hs-CRP).


CONCLUSIONS
We observed a decrease of body weight after 9 and 12 months in the group treated with sibutramine, but not in the control group. Regarding glycaemic and lipid profile, although there are differences seen over time within each of the groups, we did not obtain any significant differences between the two groups. Both placebo and sibutramine gave a similar improvement of HOMA-IR, leptin, TNF-α, ADN, and Hs-CRP. No vaspin variations were observed in either group.


CONCLUSIONS
Sibutramine resulted in a decrease in body weight at 9 months and at 12 months that was not observed with placebo. Although there were differences seen over time within each of the groups, there were no significant differences between groups for any other parameter that we measured.
Department of Internal Medicine and Therapeutics, University of Pavia, Pavia "G. Descovich"Atherosclerosis Study Center, Department of Internal Medicine, Aging and Kidney Diseases, University of Bologna, Bologna, Italy. giuseppe.derosa@unipv.it
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D052242:Adiponectin / Q000097:blood; D001067:Appetite Depressants / Q000009:adverse effects / Q000494:pharmacology*; D001786:Blood Glucose; D015992:Body Mass Index; D001835:Body Weight; D002097:C-Reactive Protein / Q000378:metabolism; D015897:Comorbidity; D003503:Cyclobutanes / Q000009:adverse effects / Q000494:pharmacology*; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000453:epidemiology* / Q000378:metabolism; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007004:Hypoglycemic Agents / Q000494:pharmacology; D007249:Inflammation / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology / Q000503:physiopathology; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D020738:Leptin / Q000097:blood; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000188:drug therapy* / Q000453:epidemiology* / Q000473:pathology / Q000503:physiopathology; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D045162:Thiazolidinediones / Q000494:pharmacology; D013997:Time Factors
D052242:Adiponectin; D001067:Appetite Depressants; D001786:Blood Glucose; D002097:C-Reactive Protein; D003503:Cyclobutanes; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D020738:Leptin; D008055:Lipids; D010919:Placebos; D045162:Thiazolidinediones; C058254:sibutramine