The effects of gliclazide, metformin, and acarbose on body composition in patients with newly diagnosed type 2 diabetes mellitus.

Current Therapeutic Research 75 (2013) 88–92 Contents lists available at ScienceDirect Current Therapeutic Research journal homepage: www.elsevier.com/locate/cuthre The Effects of Gliclazide, Metformin, and Acarbose on Body Composition in Patients with Newly Diagnosed Type 2 Diabetes Mellitus☆ Hua Wang, MD1, Yafang Ni, MS1, Shuo Yang, BS2, Huizhi Li, BS1, Xu Li, MD1, Bo Feng, MD1,n 1 2 Department of Endocrinology, East Hospital, Tongji University School of Medicine, Shanghai, China Department of Radiology, East Hospital, Tongji University School of Medicine, Shanghai, China a r t i c l e in f o abstract Article history: Accepted 9 October 2013 Background: Although numerous clinical trials have evaluated the body weight change achieved using diabetes medications alone or in combinations, the composition of body weight change in these clinical trials has rarely been assessed. Objective: We aimed to evaluate the effects of gliclazide, metformin, and acarbose monotherapy on body composition, fat distribution, and other cardiometabolic risk factors in patients with newly diagnosed type 2 diabetes. Methods: A total of 86 patients with newly diagnosed type 2 diabetes mellitus were randomly assigned to receive gliclazide, metformin, or acarbose for 6 months. Dual-energy x-ray absorptiometry; abdominal computed tomography scans; and measurements of adiponectin, leptin, and lipid levels were performed before and after 6-month monodrug therapy. Results: Blood glucose and glycosylated hemoglobin levels significantly improved after 6 months of monodrug therapy. During the 6 months of use of the 3 antidiabetes medications, the majority of participants experienced fat mass loss and lean mass gain. Metformin monotherapy in patients with newly diagnosed type 2 diabetes led to a significant decrease in percent body fat (P ¼ 0.029) and body fat mass (P ¼ 0.038). Levels of serum total cholesterol (P ¼ 0.004), triglycerides (P ¼ 0.014), and adiponectin (P ¼ 0.001) took a favorable turn after metformin treatment. The 3 antidiabetes medications caused no significant change in abdominal fat distribution, waist circumstance, and blood pressure during the 6 months. Conclusions: Our results suggest metformin therapy in patients with newly diagnosed type 2 diabetes can improve cardiometabolic risk markers. Moreover, body composition change induced by gliclazide and acarbose was not likely to be simple fat deposition. & 2013. The Authors. Published by Elsevier Inc. All rights reserved. Key Words: body composition fat distribution monodrug therapy newly diagnosed type 2 diabetes Introduction It is well known that obesity and diabetes mellitus have a close relationship. The established pharmacotherapies for diabetes can improve glycemic control and thus reduce the risk of diabetesrelated complications. However, weight gain is a frequent side effect of antihyperglycemia therapy in patients with type 2 diabetes mellitus.1–3 It has been shown that weight gain increases the ☆ This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-No Derivative Works License, which permits non-commercial use, distribution, and reproduction in any medium, provided the original author and source are credited. n Address correspondence to: Bo Feng, MD, Department of Endocrinology, East Hospital, Tongji University School of Medicine, 150 Jimo Rd, Pudong District, Shanghai 200120, China. E-mail address: (B. Feng). risk of cardiovascular disease, but the amount of body fat, rather than the amount of excess body weight, may be a better indicator for the health risks of type 2 diabetes mellitus and cardiovascular disease.4 Although numerous clinical trials have evaluated the body weight change induced by diabetes medications alone or in combinations,5,6 the composition of body weight change in these clinical trials has rarely been assessed.7,8 A study by Lee et al7 indicated that metformin may attenuate lean mass loss in older men with diabetes, but oral glucose tolerance testing was not performed in their study. Patients’ classification was assessed by prescription medication inventory without regard for the confused effect of antihyperglycemic drug combinations. The study by Rodrıguez-Moctezuma et al8 indicated that the administration of metformin for 2 months improved the parameters of body composition (ie, a decrease in body weight and fat with an increase in lean mass) in patients without diabetes but with risk factors for type 2 diabetes. Body composition in their study was 0011-393X/$ - see front matter & 2013. The Authors. Published by Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.curtheres.2013.10.002 H. Wang et al. / Current Therapeutic Research 75 (2013) 88–92 measured by bioelectrical impedance and abdominal fat distribution was not involved. Our study evaluated the effects of monodrug therapy on cardiometabolic risk profile (ie, body weight, body composition, fat distribution, blood pressure, lipid profile, and adipocytokines) in patients with newly diagnosed type 2 diabetes. Sulfonylureas, metformin, and α-glucosidase inhibitors are commonly used in the treatment of patients with type 2 diabetes. We chose Diamicron MR (Servier, Hawthorne,Victoria, Australia), Glucophage (BristolMyers Squibb, New York, NY), and Precose (Bayer Healthcare Pharmaceuticals, Wayne, NJ) as representatives of gliclazide, metformin, and acarbose, respectively, according to the report “Pharmaceutical Sales in the East China in 2009” by IMS Health. Patients and Methods Patients A total of 90 patients (drug-naive) with hyperglycemia (glycosylated hemoglobin [HbA1c] 7%–10%)9 were recruited from our outpatient clinic between October 2010 and December 2011. They were patients newly diagnosed with type 2 diabetes according to the results of oral glucose tolerance test (World Health Organization 1999 criteria). Patients with severe congestive heart failure (ie, New York Heart Association functional class III–IV), liver dysfunction (ie, aspartate aminotransferase and/or alanine aminotransferase 41.5  upper limit of normal), and renal dysfunction (ie, creatinine clearance o 90 mL/min; creatinine clearance was estimated from serum creatinine concentration using the Cockcroft-Gault formula) were excluded.10 Patients with extraordinary body weight (ie, body mass index o 18.5 or 4 35 kg/m2) and obvious dyslipidemia (ie, serum total cholesterol Z6.22 mmol/L, triglycerides Z2.26 mmol/L, and low-density lipoprotein cholesterol Z 4.14 mmol/L) were also excluded. Patients receiving antidiabetes treatment before the study, or taking pharmacologic agents known to affect carbohydrate homeostasis or influence lipid levels were also excluded. No patient enrolled in this study was diagnosed with type 1 diabetes mellitus. After 4 weeks of diet treatment (energy intake  30 kcal/kg ideal body weight per day), the enrolled patients were divided into 3 groups by simple randomization (ran (...truncated)