The effect of pegylated recombinant human leptin (PEG-OB) on weight loss and inflammatory status in obese subjects.
OBJECTIVE
To investigate whether weekly subcutaneous administration of 60 mg of long-acting pegylated human leptin (PEG-OB) for 8 weeks was able to influence weight loss, metabolic profile and inflammatory status of obese subjects on a mildly hypoenergetic diet (deficit: 3.2 MJ/day).


METHODS
A prospective, randomized, double-blind and placebo-controlled single-center trial.


METHODS
Twenty-eight healthy, obese subjects (16 women, 12 men; age 22-65 y; body mass index 27.7-38.7 kg/m2).


METHODS
Bodyweight, metabolic profile (including lipids), C-reactive protein (CRP) and soluble TNF alpha-receptor (sTNF-R) 55 and 75 levels.


RESULTS
At the end of the study no significant differences in the delta or percentage weight loss between the placebo (n = 14) and PEG-OB (n = 14) groups was observed. Also the changes in metabolic profile, CRP, sTNF-R55 and R75 concentrations between the two groups after 8 weeks of treatment did not differ.


CONCLUSIONS
Weekly injection of 60 mg PEG-OB did not lead to additional weight loss after 8 weeks of treatment. Furthermore, PEG-OB administration did not affect the changes in metabolic profile and the inflammatory status of obese subjects.
Hukshorn
C J
CJ
Nutrition and Toxicology Research Institute Maastricht, Department of Human Biology, Maastricht University, The Netherlands. c.hukshorn@hb.unimaas.nl
van Dielen
F M H
FM
Buurman
W A
WA
Westerterp-Plantenga
M S
MS
Campfield
L A
LA
Saris
W H M
WH
D000293:Adolescent; D000328:Adult; D000368:Aged; D001786:Blood Glucose / Q000032:analysis; D015992:Body Mass Index; D001835:Body Weight; D002097:C-Reactive Protein / Q000032:analysis; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007249:Inflammation / Q000097:blood / Q000150:complications*; D007328:Insulin / Q000097:blood; D007333:Insulin Resistance; D020738:Leptin / Q000008:administration & dosage / Q000097:blood / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000097:blood / Q000150:complications / Q000628:therapy*; D010919:Placebos; D011446:Prospective Studies; D054411:Receptors, Leptin; D018124:Receptors, Tumor Necrosis Factor / Q000032:analysis; D015431:Weight Loss
D001786:Blood Glucose; D007328:Insulin; C515448:LEPR protein, human; D020738:Leptin; D010919:Placebos; D054411:Receptors, Leptin; D018124:Receptors, Tumor Necrosis Factor; D002097:C-Reactive Protein