title: Impact of synthetic ghrelin administration for patients with severe body weight reduction more than 1 year after gastrectomy: a phase II clinical trial.
abstract: OBJECTIVE
  Ghrelin is mainly secreted from the stomach and plays a role in appetite, weight gain, and the promotion of a positive energy balance. The levels of ghrelin decrease immediately after gastrectomy. We herein investigated the effect of the administration of synthetic ghrelin to treat postoperative severe weight loss in a prospective, one-arm clinical trial to develop new strategies for weight gain.
  
  
  METHODS
  Ten patients (four distal gastrectomy and six total gastrectomy) received ghrelin treatment. Eligibility criteria included patients who underwent gastrectomy more than 1 year previously and 15 % body weight loss from the preoperative weight or a body mass index under 19. Synthetic human ghrelin (3 μg/kg) was administered to the patients twice a day for 1 week. Oral intake of calories, appetite [evaluated using the visual analog scale (VAS)], and body weight before and during administration of ghrelin were compared.
  
  
  RESULTS
  There was a significant difference in the oral food intake before and during treatment (before treatment: 1236 ± 409 kcal vs. during treatment: 1398 ± 365 kcal, p = 0.039), and the VAS for appetite significantly improved with each day of ghrelin administration (p < 0.05). Significant amounts of body weight were gained (39.5 ± 6.8 vs. 40.1 ± 6.9, p = 0.037).
  
  
  CONCLUSIONS
  The administration of synthetic ghrelin improved the food intake and was effective for treating appetite loss and body weight loss. Synthetic ghrelin may be a promising new therapy for severe body weight loss following gastrectomy.
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan. stakiguchi@gesurg.med.osaka-u.ac.jp.
authors.forename: Shuji
authors.initials: S
authors.lastname: Takiguchi
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Miyazaki
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Takahashi
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Yukinori
authors.initials: Y
authors.lastname: Kurokawa
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Makoto
authors.initials: M
authors.lastname: Yamasaki
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Kiyokazu
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Miyata
authors.affiliation: Department of Biochemistry, National Cardiovascular Center Research Institute, Osaka, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hosoda
authors.affiliation: Department of Biochemistry, National Cardiovascular Center Research Institute, Osaka, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Kangawa
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Mori
authors.affiliation: Division of Gastroenterological Surgery, Department of Surgery, Graduate School of Medicine, Osaka University, 2-2, E2, Yamadaoka, Suita, Osaka, 565-0871, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Doki
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001066:Appetite / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D004435:Eating / Q000187:drug effects; D001068:Feeding and Eating Disorders / Q000188:drug therapy*; D005260:Female; D005743:Gastrectomy; D054439:Ghrelin / Q000008:administration & dosage* / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D064887:Observational Studies as Topic; D011183:Postoperative Complications / Q000188:drug therapy*; D011446:Prospective Studies; D012720:Severity of Illness Index; D013268:Stimulation, Chemical; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss
chemical_list: D054439:Ghrelin
keywords: Body weight loss; Gastric cancer; Ghrelin