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

未提供0 个研究点目标入组 88 人开始时间: 待定最近更新: 2024年9月9日

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 88
主要终点: -

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized Controlled Trial
干预模型: Parallel Assignment
主要目的: Treatment Purpose
盲法: Open(masking Not Used)

入排标准

年龄范围: 70age old over 至 No limit（—）
性别: All

入选标准

•Patients who meet all of the following criteria are included in this study;
•Patients with type 2 diabetes mellitus.
•Male and female aged 65 years or older at giving their consent.
•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.
•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.
•Patients whose BMI is 18 kg/m2 or higher and 30 kg/m2 or less at giving their consent.
•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.
•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.
•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;
•Patients with severe renal dysfunction (eGFR of less than 30 mL/min/1.73m2).
•Patients who are treated with insulin or GLP-1 receptor agonists.
•Patients who continuously take leucine-containing amino acids within 12 weeks before giving their consent.
•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.
•Patients who have history of cerebrovascular or cardiovascular impairment.
•Patients with heart failure (NYHA classification II to iV)
•Patients with severe hepatic dysfunction (any of ALT, AST or ALP is more than 3 times of Upper Limit of Normal.
•Patients who have history of pancreatitis.
•Patients with diabetic retinopathy (patients with proliferative retinopathy, vitreous hemorrhage, or other severe clinical abnormality).
•Patients who have history of gastrointestinal tract surgery.
•Patients who have history of malignant tumor within 5 years before giving their consent.
•Patients with severe infection or trauma, or in the perioperative period.
•Patients with excess drinking habit (5 days or more per week)
•Patients whose latest hemoglobin before giving their consent is less than 11.0 g/dL.
•Patients who have difficultiey following the instructions of the responsible investigator or subinvestigators.
•Patients who are participating in other clinical studies.
•Patients with other conditions that the responsible investigator or subinvestigators think inappropriate to participate in the study.

结局指标

主要结局

Change in HbA1c from baseline (week 0) to week 52

次要结局

Change in body weight(week 0 to week 52)
Change in body composition(week 0 to week 52)
Change in handgrip(week 0 to week 52)
Change in frequency of meal intake(week 0 to week 52)
Change in HOMA-IR(week 0 to week 52)
Change in inflammatory cytokine(week 0 to week 52)
Frequency of adverse event or disease-or-the-like(week 0 to week 52)

研究者

发起方

未提供

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