NCT07187479招募中不适用
Randomized, Open Label Study to Examine the Outcomes of Physiologic Insulin Resensitization in Patients With Chronic Kidney Disease and Type 2 Diabetes Mellitus
Well Cell Global2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年10月14日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Estimated Glomular Filtration Rate (eGFR)
研究概览
简要总结
The purpose of this research is to evaluate outcomes of physiologic insulin re-sensitization (PIR) in patients with Chronic Kidney Disease (CKD) and Type 2 Diabetes Mellitus (T2DM).
详细描述
The primary objective of this study is to assess the outcomes of Physiologic Insulin Resensitization (PIR) treatment compared to standard of care (SOC) on renal patients with a diagnosis of chronic kidney disease (CKD) (stages 3b, 4 and 5) and Type 2 diabetes mellitus (T2DM)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is age 18 or older (male or female)
- •Have a documented diagnosis of CKD stage 3b, 4, or 5 and T2DM of 6 months or greater prior to screening. Patients may have treatment regimens associated with T2DM that include diabetic oral and/or injectable medications including insulin and/or GLP-1 receptor agonists.
- •In the opinion of the Investigator, has been on an appropriate, stable regimen for management of any complications present for the past six (6) months.
- •In the opinion of the Investigator, is able to do all of the following:
- •Provide valid informed consent.
- •Understand and comply with study procedures as presented in the consent process.
- •Has the capacity or support to attend all required visits.
- •If female, the subject must meet either of the following sets of conditions:
- •o Is of non-childbearing potential, defined as meeting either of the following criteria:
- •Age ≥50 years and post-menopausal for at least one (1) year
- •Surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy
- •Is of childbearing potential and meets both of the following criteria:
- •Has a negative serum pregnancy test (beta-human chorionic gonadotropin) at screening.
- •Agrees to practice an acceptable method of birth control (contraception) from screening until at least 30 days after last study treatment
排除标准
- •Has in the past two (2) years received treatment for a malignancy.
- •Current pregnancy or intends to become pregnant during the study
- •Has in the past one (1) year used non-prescription opioids or psychoactive drugs.
- •Has in the past six (6) months had a hypoglycemic event requiring urgent care and/or administration of glucagon, osteocalcin, or parenteral glucose, unless approved for enrollment by the Medical Monitor.
- •Has within the past one (1) month participated in a clinical study involving either of the following:
- •An investigational drug or procedure for any clinical indication
- •An investigation method for glucose control using approved agents
- •Is nursing or is planning to nurse during the study.
- •Has at screening a positive test for HIV (4th gen. screen), HBsAg, or HCV viral load.
- •Has at screening, one or more of the following abnormal lab results:
- •Hb <8 g/dL
- •WBC <2,000/µL
- •Platelets <50,000/µL
- •ALT, AST, or Alkaline Phosphatase >5x ULN
- •ALT or AST >2.5x ULN, and Total Bilirubin >2x ULN
- •Serum albumin <3 g/dL
- •Has - in the opinion of the Investigator - psychiatric, behavioral, cognitive and/or clinical dysfunction (whether or not related to known medical illness or drug / alcohol use) that would affect the subject's safety and/or compliance.
- •Is on active dialysis at time of screening
研究组 & 干预措施
Physiologic Insulin Resensitization (PIR) Group
Experimental
Subject to receive Physiologic Insulin Resensitization (PIR)
干预措施: Physiologic Insulin Resensitization (PIR) (Other)
Standard of Care (SOC) Group
No Intervention
Subjects will receive standard of care
结局指标
主要结局
Estimated Glomular Filtration Rate (eGFR)
时间窗: 12 and 24 weeks
Assess the eGFR of patients in the PIR group as compared to the SOC group
Blood Urea Nitrogen/Creatinine Ratio (BUN/Cr)
时间窗: 12 and 24 weeks
Assess the BUN/Cr of patients in the PIR group as compared to the SOC group
Cystatin C
时间窗: 12 and 24 weeks
Assess the Cystatin C of patients in the PIR group as compared to the SOC group
Urine albumin-creatinine ratio (ACR)
时间窗: 12 and 24 weeks
Assess the urine ACR of patients in the PIR group as compared to the SOC group
次要结局
- Prescribed medication usage for control of symptoms(12 and 24 weeks)
- Hemoglobin A1c (HbA1c)(12 and 24 weeks)
- Fasting blood glucose(12 and 24 weeks)
- Fasting insulin level(12 and 24 weeks)
- HOMA-IR(12 and 24 weeks)
- Lipid profile(12 and 24 weeks)
- C peptide(12 and 24 weeks)
- Hemoglobin A1c (HbA1c)(12 and 24 weeks)
- Fasting blood glucose(12 and 24 weeks)
- Prescribed medication usage for control of symptoms(12 and 24 weeks)
- C peptide(12 and 24 weeks)
- EQ-5D-5L Quality of Life (EuroQol 5-Dimension 5-Level Questionnaire)(12 and 24 weeks)
- Fasting insulin level(12 and 24 weeks)
- HOMA-IR(12 and 24 weeks)
- Lipid profile(12 and 24 weeks)
- Blood Pressure(12 and 24 weeks)
研究者
研究点 (2)
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