title: An intragastric balloon in the treatment of obese individuals with metabolic syndrome: a randomized controlled study.
abstract: OBJECTIVE
  There are limited controlled data for intragastric balloons (IGB) in obesity treatment. This randomized, controlled study evaluated the efficacy and safety of an IGB in obese individuals with metabolic syndrome (MS).
  
  
  METHODS
  Sixty-six adults (BMI: 30-40 kg/m(2)) were randomized to IGB for 6 months, with a 12 month behavioral modification (IGB Group; "IGBG"), or 12 month behavioral modification alone (Control Group; "CG"). The primary outcome was percentage change in body weight.
  
  
  RESULTS
  Thirty-one subjects (female: 68%; mean age: 43; mean BMI: 36.0) were randomized to IGBG and 35 (66%; 48; 36.7) to CG. At 6 months, there was a significantly greater weight loss in the IGBG: -14.2 vs. -4.8; P < 0.0001. This was associated with a significantly greater reduction in waist circumference, and an improvement in quality of life, with a trend for a larger %MS remission (50% vs. 30%; n.s.). At month 12, the differences in weight loss were enduring: -9.2 vs. -5.2; P = 0.007. Gastrointestinal-related adverse events were common in the IGBG, resolving predominantly within two weeks. The IGB was removed prematurely in three subjects (one for refractory gastrointestinal symptoms).
  
  
  CONCLUSIONS
  Statistically significant and clinically relevant improvements in weight loss and health outcomes were observed with the IGBG at 6 months versus behavioral modification alone. The differential weight loss was still evident 6 months after IGB removal.
authors.affiliation: The Boden Institute, The University of Sydney, NSW, Australia. nick.fuller@sydney.edu.au
authors.forename: Nicholas R
authors.initials: NR
authors.lastname: Fuller
authors.forename: Suzanne
authors.initials: S
authors.lastname: Pearson
authors.forename: Namson S
authors.initials: NS
authors.lastname: Lau
authors.forename: John
authors.initials: J
authors.lastname: Wlodarczyk
authors.forename: Michael B
authors.initials: MB
authors.lastname: Halstead
authors.forename: Hoi-Poh
authors.initials: HP
authors.lastname: Tee
authors.forename: Raman
authors.initials: R
authors.lastname: Chettiar
authors.forename: Arthur J
authors.initials: AJ
authors.lastname: Kaffes
mesh_terms: D000328:Adult; D015992:Body Mass Index; D002784:Cholesterol / Q000097:blood; D004032:Diet; D015444:Exercise; D005260:Female; D015905:Gastric Balloon; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D024821:Metabolic Syndrome / Q000150:complications / Q000628:therapy*; D008875:Middle Aged; D009767:Obesity, Morbid / Q000150:complications / Q000628:therapy*; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D055105:Waist Circumference; D015431:Weight Loss
chemical_list: D014280:Triglycerides; D002784:Cholesterol