title: The effect of pegylated recombinant human leptin (PEG-OB) on weight loss and inflammatory status in obese subjects.
abstract: 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.
authors.affiliation: Nutrition and Toxicology Research Institute Maastricht, Department of Human Biology, Maastricht University, The Netherlands. c.hukshorn@hb.unimaas.nl
authors.forename: C J
authors.initials: CJ
authors.lastname: Hukshorn
authors.forename: F M H
authors.initials: FM
authors.lastname: van Dielen
authors.forename: W A
authors.initials: WA
authors.lastname: Buurman
authors.forename: M S
authors.initials: MS
authors.lastname: Westerterp-Plantenga
authors.forename: L A
authors.initials: LA
authors.lastname: Campfield
authors.forename: W H M
authors.initials: WH
authors.lastname: Saris
mesh_terms: 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
chemical_list: 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