title: Effects of miglitol, sitagliptin, and initial combination therapy with both on plasma incretin responses to a mixed meal and visceral fat in over-weight Japanese patients with type 2 diabetes. "the MASTER randomized, controlled trial".
abstract: OBJECTIVE
  To assess changes in circulating incretin levels and body fat compositions with initial combination therapy with α-glucosidase inhibitor and dipeptidyl peptidase-4 inhibitor in patients with type 2 diabetes (T2D).
  
  
  METHODS
  In this multicenter open-label 24-week trial, Japanese over-weight (BMI ≥ 25 kg/m(2)) patients with T2D not taking medication or taking metformin and/or sulfonylurea were randomly assigned to receive either 50mg of miglitol three times a day (M, n=14), 50mg of sitagliptin once a day (S, n=14), or a combination of both (M+S, n=13). Changes in plasma incretin levels during a meal tolerance test (MTT) and body fat composition with impedance method were evaluated.
  
  
  RESULTS
  During MTT, postprandial plasma glucose levels decreased more after M+S than after M or S, and postprandial serum insulin levels decreased significantly after M and M+S whereas they increased after S. After M, active gastric inhibitory polypeptide (aGIP) decreased significantly at 30 min despite a significant increase at 120 min. After S, aGIP levels increased significantly throughout the MTT. After M+S, aGIP increased significantly at 0 and 120 min despite of significant decrease at 30 min. M+S further enhanced postprandial active glucagon-like peptide-1 levels during MTT than S did. Total body fat mass decreased significantly after M and M+S. Visceral fat mass decreased significantly only after M+S. Serum adiponectin increased significantly only after M+S.
  
  
  CONCLUSIONS
  In over-weight patients with T2D, M+S may have a beneficial effect on adiposity with relation to these different effects on two incretins.
authors.affiliation: Akita University Graduate School of Medicine, Department of Endocrinology, Diabetes and Geriatric Medicine, Akita, Japan; Hiraka General Hospital, Gastroenterology and Diabetes Unit, Yokote, Japan.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Mikada
authors.affiliation: Akita University Graduate School of Medicine, Department of Endocrinology, Diabetes and Geriatric Medicine, Akita, Japan. Electronic address: narita@med.akita-u.ac.jp.
authors.forename: Takuma
authors.initials: T
authors.lastname: Narita
authors.affiliation: Jiyugaoka Medical Clinic, Internal Medicine, Obihiro, Japan.
authors.forename: Hiroki
authors.initials: H
authors.lastname: Yokoyama
authors.affiliation: Jiyugaoka Medical Clinic, Internal Medicine, Obihiro, Japan.
authors.forename: Risa
authors.initials: R
authors.lastname: Yamashita
authors.affiliation: Hiraka General Hospital, Gastroenterology and Diabetes Unit, Yokote, Japan.
authors.forename: Yohei
authors.initials: Y
authors.lastname: Horikawa
authors.affiliation: Hiraka General Hospital, Gastroenterology and Diabetes Unit, Yokote, Japan; Akita University School of Medicine, Metabolism and Clinical Nutrition, Akita, Japan.
authors.forename: Katsushi
authors.initials: K
authors.lastname: Tsukiyama
authors.affiliation: Akita University Graduate School of Medicine, Department of Endocrinology, Diabetes and Geriatric Medicine, Akita, Japan.
authors.forename: Yuichiro
authors.initials: Y
authors.lastname: Yamada
mesh_terms: D017485:1-Deoxynojirimycin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000378:metabolism / Q000628:therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage; D054795:Incretins / Q000097:blood*; D050152:Intra-Abdominal Fat / Q000187:drug effects / Q000378:metabolism*; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D050177:Overweight / Q000150:complications* / Q000453:epidemiology / Q000378:metabolism; D019518:Postprandial Period; D011719:Pyrazines / Q000008:administration & dosage*; D000068900:Sitagliptin Phosphate; D013997:Time Factors; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage*
chemical_list: D007004:Hypoglycemic Agents; D054795:Incretins; D011719:Pyrazines; D014230:Triazoles; C045621:miglitol; D017485:1-Deoxynojirimycin; D000068900:Sitagliptin Phosphate
keywords: Adiponectin; Alpha-glucosidase inhibitor; Dipeptidyl peptidase-4 inhibitor; Gastiric inhibitory polypeptide; Obesity