PMID- 21070297
OWN - NLM
STAT- MEDLINE
DCOM- 20120308
LR  - 20221207
IS  - 1365-2710 (Electronic)
IS  - 0269-4727 (Linking)
VI  - 36
IP  - 5
DP  - 2011 Oct
TI  - Variation of inflammatory parameters after sibutramine treatment compared to 
      placebo in type 2 diabetic patients.
PG  - 592-601
LID - 10.1111/j.1365-2710.2010.01217.x [doi]
AB  - WHAT IS KNOWN AND 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-alpha (TNF-alpha), 
      adiponectin (ADN), vaspin, high sensitivity C-reactive protein (Hs-CRP). RESULTS 
      AND DISCUSSION: 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-alpha, ADN, and Hs-CRP. No vaspin variations were observed in either 
      group. WHAT IS NEW AND CONCLUSION: 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.
CI  - (c) 2010 The Authors. JCPT (c) 2010 Blackwell Publishing Ltd.
FAU - Derosa, G
AU  - Derosa G
AD  - 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
FAU - Maffioli, P
AU  - Maffioli P
FAU - Ferrari, I
AU  - Ferrari I
FAU - Palumbo, I
AU  - Palumbo I
FAU - Randazzo, S
AU  - Randazzo S
FAU - D'Angelo, A
AU  - D'Angelo A
FAU - Cicero, A F G
AU  - Cicero AF
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20101112
PL  - England
TA  - J Clin Pharm Ther
JT  - Journal of clinical pharmacy and therapeutics
JID - 8704308
RN  - 0 (Adiponectin)
RN  - 0 (Appetite Depressants)
RN  - 0 (Blood Glucose)
RN  - 0 (Cyclobutanes)
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
RN  - 0 (Leptin)
RN  - 0 (Lipids)
RN  - 0 (Placebos)
RN  - 0 (Thiazolidinediones)
RN  - 9007-41-4 (C-Reactive Protein)
RN  - WV5EC51866 (sibutramine)
SB  - IM
MH  - Adiponectin/blood
MH  - Appetite Depressants/adverse effects/*pharmacology
MH  - Blood Glucose
MH  - Body Mass Index
MH  - Body Weight
MH  - C-Reactive Protein/metabolism
MH  - Comorbidity
MH  - Cyclobutanes/adverse effects/*pharmacology
MH  - Diabetes Mellitus, Type 2/*drug therapy/*epidemiology/metabolism
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Glycated Hemoglobin/metabolism
MH  - Humans
MH  - Hypoglycemic Agents/pharmacology
MH  - Inflammation/*drug therapy/metabolism/pathology/physiopathology
MH  - Insulin/blood
MH  - Insulin Resistance
MH  - Leptin/blood
MH  - Lipids/blood
MH  - Male
MH  - Middle Aged
MH  - Obesity/*drug therapy/*epidemiology/pathology/physiopathology
MH  - Placebos
MH  - Randomized Controlled Trials as Topic
MH  - Thiazolidinediones/pharmacology
MH  - Time Factors
EDAT- 2010/11/13 06:00
MHDA- 2012/03/09 06:00
CRDT- 2010/11/13 06:00
PHST- 2010/11/13 06:00 [entrez]
PHST- 2010/11/13 06:00 [pubmed]
PHST- 2012/03/09 06:00 [medline]
AID - 10.1111/j.1365-2710.2010.01217.x [doi]
PST - ppublish
SO  - J Clin Pharm Ther. 2011 Oct;36(5):592-601. doi: 10.1111/j.1365-2710.2010.01217.x. 
      Epub 2010 Nov 12.