title: Effects of bile-acid-binding resin (colestimide) on blood glucose and visceral fat in Japanese patients with type 2 diabetes mellitus and hypercholesterolemia: an open-label, randomized, case-control, crossover study.
abstract: OBJECTIVE
  The objective was to examine the effects of colestimide on blood glucose, visceral fat, adipocytokines, and bile acid conjugate fractions in Japanese patients.
  
  
  METHODS
  This study was an open-label, randomized, case-control, crossover study of colestimide 3 g/day in 40 Japanese patients with type 2 diabetes mellitus (T2D) and hypercholesterolemia. Patients were assigned to the colestimide group in which pravastatin and colestimide were administered orally and to the statin group in which pravastatin alone was administered orally. The principal outcome measures were serum lipid levels, fasting plasma glucose level in the early morning, hemoglobin A1c (HbA(1c)), visceral fat area (VFA), and serum 1,5-anhydroglucitol (1,5-AG) level.
  
  
  RESULTS
  Serum low-density lipoprotein cholesterol levels significantly decreased from 113±38 mg/dl at baseline to 90±20 mg/dl (P=.009) at week 12 of colestimide administration. HbA(1c) significantly decreased from 7.4%±0.9% at baseline to 6.9%±0.9% (P=.001) at week 12 of colestimide administration. Serum 1,5-AG levels increased from 9.4±10.1 μg/ml to 12.4±9.5 μg/ml (P=.05) at week 12 of colestimide administration. The statin group showed no significant changes in lipids and 1,5-AG. However, ΔVFA was inversely correlated with Δcholic acid, and multivariate analysis revealed that ΔVFA was a significant explanatory variable.
  
  
  CONCLUSIONS
  Colestimide holds promise not only for the treatment of hypercholesterolemia but also for the possible improvement of T2D and visceral fat obesity.
authors.affiliation: Department of Internal Medicine (Divisions of Cardiology, Hepatology, Geriatrics and Integrated Medicine), Nippon Medical School, Tokyo, Japan. t-suzuki@nms.ac.jp
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Suzuki
authors.forename: Kenzo
authors.initials: K
authors.lastname: Oba
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Igari
authors.forename: Kentaro
authors.initials: K
authors.lastname: Watanabe
authors.forename: Noriaki
authors.initials: N
authors.lastname: Matsumura
authors.forename: Shoko
authors.initials: S
authors.lastname: Futami-Suda
authors.forename: Motoshi
authors.initials: M
authors.lastname: Ouchi
authors.forename: Kazunari
authors.initials: K
authors.lastname: Suzuki
authors.forename: Ken-Ichi
authors.initials: K
authors.lastname: Sekimizu
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Kigawa
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nakano
mesh_terms: D000368:Aged; D000924:Anticholesteremic Agents / Q000627:therapeutic use; D044466:Asian People / Q000706:statistics & numerical data; D001647:Bile Acids and Salts / Q000037:antagonists & inhibitors*; D001786:Blood Glucose / Q000032:analysis / Q000187:drug effects*; D008078:Cholesterol, LDL / Q000097:blood; D018592:Cross-Over Studies; D003847:Deoxyglucose / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D004811:Epichlorohydrin / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D007093:Imidazoles / Q000627:therapeutic use*; D050152:Intra-Abdominal Fat / Q000187:drug effects*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D012117:Resins, Synthetic / Q000627:therapeutic use*; D019821:Simvastatin / Q000627:therapeutic use
chemical_list: D000924:Anticholesteremic Agents; D001647:Bile Acids and Salts; D001786:Blood Glucose; D008078:Cholesterol, LDL; D003847:Deoxyglucose; D004811:Epichlorohydrin; D006442:Glycated Hemoglobin; D007093:Imidazoles; D008055:Lipids; D012117:Resins, Synthetic; D019821:Simvastatin; C417427:colestimide; C517652:hemoglobin A1c protein, human; C006584:1,5-anhydroglucitol