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- Title
Treating Hyperglycemia in Newly-Diagnosed T2DM by Oral Hypoglycemic Agents (OHAs) vs. Lifestyle Improvement: Japan Early Diabetes Intervention Study(JEDIS).
- Authors
Kawazu, Shoji; Kuzuya, Takeshi; Fujita, Toshiharu; Nishimura, Rimei; Kanazawa, Yasunori
- Abstract
[Aims] Since diabetic vascular disease, particularly microangiopathy, is closely associated with severity of hyperglycemia, preventing worsening hyperglycemia in newly-diagnosed T2DM may inhibit diabetic vascular disease. Adherence to lifestyle change, the recommended initial treatment for newly-diagnosed T2DM, is often difficult, so we will examine early introduction of pharmacotherapy vs lifestyle intervention. The use of SMBG will also be evaluated. [Subjects] Men and women 30-69 y.o. without a past history of diabetes who have FPG of 100-125 mg/dl and HbA1c of 5.5-6.9% in a health checkup will take a 75g OGTT and HbA1c measurement and those with FPG≤125 mg/dl, 2h PG>=200 mg/dl and HbA1c≤6.9% measured twice will be enrolled after giving informed consent. [Design and Methods] This is a randomized, unblinded, comparative study. Subjects will be divided by BMI above (n=1280) and below (n=1280) 24 kg/m2 before randomization. Within each BMI group, the control group (n=320) will receive standard lifestyle intervention (SI) and the pharmacological intervention (PI) group will receive monotherapy starting with the lowest dose of one of 3 commercially available OHAs (acarbose, metformin, or gliclazide, n=320 for each). The primary end point is defined by FPG>=140mg/dl and HbA1c>=7.0% since these are associated with an increased risk of microangiopathy. As a secondary aim, subjects providing informed consent to participate in the SMBG substudy will be randomized to the use or not of SMBG as a partial factor plan design. JEDIS will continue for 3 years after enrollment. [Conclusion] JEDIS will elucidate whether in newly-diagnosed T2DM early introduction of pharmacotherapy and/or the use of SMBG will prevent the progression of hyperglycemia and thereby reduce the risk of vascular disease.
- Publication
Diabetes, 2007, Vol 56, pA563
- ISSN
0012-1797
- Publication type
Academic Journal