JPRN-jRCTs041210048招募中未知
Benefits And safety of Long-term administration of Luseogliflozin and Amino acid Supplements with intensive exercise Treatment in elderly patients with type 2 diabetes mellitus; multicenter, open-label, randomized-controlled trial
Yabe Daisuke0 个研究点目标入组 88 人开始时间: 2021年8月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 88
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 70age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria are included in this study;
- •1) Patients with type 2 diabetes mellitus.
- •2) Male and female aged 65 years or older at giving their consent.
- •3) Patients who do not take any oral hypoglycemic agents (OHAs) at giving their consent, or who take only one OHA among sulfonylurea, glinide, alpha-glucosidase inhibitor, DPP-4 inhibitor, metformin, or pioglitazone.
- •4) Patients whose HbA1c is 7.0% or higher and 9.0% or less in case of OHA-untreated patients, or patients whose HbA1c is 6.0% or higher and 8.0% or less in case of patients who take one OHA.
- •5) Patients whose BMI is 18 kg/m2 or higher and 30 kg/m2 or less at giving their consent.
- •6) Male whose SMI is 7.0 kg/m2 or higher, or female whose SMI is 5.7 kg/m2 or higher at giving their consent.
- •7) Male whose handgrip (mean of right and left handgrip) is 28 kg or higher, or female whose handgrip is 18 kg or higher at giving their consent.
- •8) Patients who provide their consent in a written form by themselves.
排除标准
- •Patients who fall into any of the following criteria are excluded from participating in the study;
- •1) Patients with severe renal dysfunction (eGFR of less than 30 mL/min/1.73m2).
- •2) Patients who are treated with insulin or GLP-1 receptor agonists.
- •3) Patients who continuously take leucine-containing amino acids within 12 weeks before giving their consent.
- •4) Patients who have watched the patient participation type movie recommendation for exercise therapy (released by Japan Association for Diabetes Education and Care), and who strengthened the exercise therapy.
- •5) Patients who have history of cerebrovascular or cardiovascular impairment.
- •6) Patients with heart failure (NYHA classification II to iV)
- •7) Patients with severe hepatic dysfunction (any of ALT, AST or ALP is more than 3 times of Upper Limit of Normal.
- •8) Patients who have history of pancreatitis.
- •9) Patients with diabetic retinopathy (patients with proliferative retinopathy, vitreous hemorrhage, or other severe clinical abnormality).
- •10) Patients who have history of gastrointestinal tract surgery.
- •11) Patients who have history of malignant tumor within 5 years before giving their consent.
- •12) Patients with severe infection or trauma, or in the perioperative period.
- •13) Patients with excess drinking habit (5 days or more per week)
- •14) Patients whose latest hemoglobin before giving their consent is less than 11.0 g/dL.
- •15) Patients who have difficultiey following the instructions of the responsible investigator or subinvestigators.
- •16) Patients who are participating in other clinical studies.
- •17) Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study.
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