Sibutramine enhances insulin sensitivity ameliorating metabolic parameters in a double-blind, randomized, placebo-controlled trial.
OBJECTIVE
To assess the effect of sibutramine-assisted weight reduction program on insulin sensitivity and metabolic parameters in obese normal glucose tolerant individuals over a period of 24 weeks.


METHODS
A double-blind, placebo-controlled, parallel, prospective clinical trial was carried out at our medical centre. Forty female normal glucose tolerant patients, body mass index: 34.3 +/- 2.9 kg/m2 and age: 41.1 +/- 9.9 (range: 19-58 years), were randomized to placebo or sibutramine, 10 mg once daily.


RESULTS
Seventeen patients from sibutramine group and 14 placebo had completed the study protocol. Significant weight change was seen in sibutramine (p < 0.01) (-5.6 kg or -6.1% vs. +0.9 kg or +1.1% in placebo). Insulin sensitivity enhanced in sibutramine group (Kitt: from 4.03 +/- 1.97 to 5.09 +/- 2.48%/min; p < 0.05). Homeostasis model assessment-IR (HOMA-IR) decreased from 7.8 +/- 6.9 to 5.6 +/- 4.5 (p < 0.05). HOMA-beta also decreased from 508 +/- 381 to 374 +/- 256 (p < 0.05). No changes were observed in the placebo control group regarding insulin sensitivity or secretion. Concomitant reductions were observed in the sibutramine group in lipid parameters (triglycerides and high-density lipoprotein-cholesterol), uric acid and gamma-glutamyl transferase (p < 0.05).


CONCLUSIONS
Sibutramine has demonstrated efficacy in reducing weight in non-diabetic women along with amelioration in insulin sensitivity and additional improvement in metabolic parameters.
Tambascia
M A
MA
Endocrinology Service, University of Campinas, São Paulo, SP, Brazil. tambasci@terra.com.br
Geloneze
B
B
Repetto
E M
EM
Geloneze
S R
SR
Picolo
M
M
Magro
D O
DO
D000328:Adult; D001067:Appetite Depressants / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D001823:Body Composition / Q000187:drug effects; D003503:Cyclobutanes / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007333:Insulin Resistance; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000188:drug therapy* / Q000503:physiopathology; D011446:Prospective Studies; D015431:Weight Loss / Q000187:drug effects
D001067:Appetite Depressants; D003503:Cyclobutanes; D008055:Lipids; C058254:sibutramine