title: Effects of combination of sibutramine and L-carnitine compared with sibutramine monotherapy on inflammatory parameters in diabetic patients.
abstract: The aim of the study was to evaluate the effects of 12-month treatment with sibutramine plus L-carnitine compared with sibutramine alone on body weight, glycemic control, insulin resistance, and inflammatory state in type 2 diabetes mellitus patients. Two hundred fifty-four patients with uncontrolled type 2 diabetes mellitus (glycated hemoglobin [HbA(1c)] >8.0%) in therapy with different oral hypoglycemic agents or insulin were enrolled in this study and randomized to take sibutramine 10 mg plus L-carnitine 2 g or sibutramine 10 mg in monotherapy. We evaluated at baseline and after 3, 6, 9, and 12 months these parameters: body weight, body mass index, HbA(1c), fasting plasma glucose, postprandial plasma glucose, fasting plasma insulin, homeostasis model assessment of insulin resistance index, total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, leptin, tumor necrosis factor-α, adiponectin, vaspin, and high-sensitivity C-reactive protein. Sibutramine plus L-carnitine gave a faster improvement of fasting plasma glucose, postprandial plasma glucose, lipid profile, leptin, tumor necrosis factor-α, and high-sensitivity C-reactive protein compared with sibutramine alone. Furthermore, there was a better improvement of body weight, HbA(1c), fasting plasma insulin, homeostasis model assessment of insulin resistance index, vaspin, and adiponectin with sibutramine plus L-carnitine compared with sibutramine alone. Sibutramine plus L-carnitine gave a better and faster improvement of all the analyzed parameters compared with sibutramine alone without giving any severe adverse effect.
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, 27100 Pavia, Italy. giuseppe.derosa@unipv.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
authors.forename: Sibilla A T
authors.initials: SA
authors.lastname: Salvadeo
authors.forename: Ilaria
authors.initials: I
authors.lastname: Ferrari
authors.forename: Alessia
authors.initials: A
authors.lastname: Gravina
authors.forename: Roberto
authors.initials: R
authors.lastname: Mereu
authors.forename: Angela
authors.initials: A
authors.lastname: D'Angelo
authors.forename: Ilaria
authors.initials: I
authors.lastname: Palumbo
authors.forename: Sabrina
authors.initials: S
authors.lastname: Randazzo
authors.forename: Arrigo F G
authors.initials: AF
authors.lastname: Cicero
mesh_terms: D000368:Aged; D001067:Appetite Depressants / Q000008:administration & dosage*; D001786:Blood Glucose / Q000378:metabolism; D001835:Body Weight / Q000187:drug effects; D002097:C-Reactive Protein / Q000378:metabolism; D002331:Carnitine / Q000008:administration & dosage*; D002784:Cholesterol / Q000097:blood; D003503:Cyclobutanes / Q000008:administration & dosage*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007333:Insulin Resistance; D020738:Leptin / Q000097:blood; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D014409:Tumor Necrosis Factor-alpha / Q000097:blood; D014803:Vitamin B Complex / Q000008:administration & dosage*
chemical_list: D001067:Appetite Depressants; D001786:Blood Glucose; D002097:C-Reactive Protein; D002331:Carnitine; D002784:Cholesterol; D003503:Cyclobutanes; D006442:Glycated Hemoglobin; D020738:Leptin; D014409:Tumor Necrosis Factor-alpha; D014803:Vitamin B Complex; C058254:sibutramine