Effect of Proliverenol on Liver Fat and Insulin Resistance in Type 2 Diabetes
Open Label Evaluator Blind,The Effect of Proliverenol Supplementation on the Visceral Adiposity Index, HOMA-IR, C-Peptide, and Controlled Attenuation Parameter (CAP) in Patients With Type 2 Diabetes at Dr. Mohammad Hoesin General Hospital in Palembang.
This study aims to determine whether Proliverenol supplementation can improve liver fat levels and blood sugar control in patients with type 2 diabetes. Participants will be divided into two groups: one group will receive Proliverenol with standar therapy of DM, and the other only receive standar therapy of DM. The study will last for 12 weeks, and participants will undergo blood tests and liver examinations."
研究概览
详细说明
Type 2 diabetes mellitus, or diabetes, is a chronic and progressive disease characterized by elevated blood sugar levels above normal. Several key mechanisms contribute to this condition, including increased oxidative stress, chronic inflammation, and the death of pancreatic β cells. This condition is exacerbated by excessive weight gain.
Proliverenol, derived from the mahkota dewa fruit (P. macrocarpa), contain an antioxidant that reduces inflammation and prevents pancreatic β-cell death. As a result, it can reduce insulin resistance in muscle and liver tissues and improve insulin secretion.
Expected results: A reduction in insulin resistance, an increase in insulin secretion, and improvements in other metabolic parameters after 3 months of proliverenol administration.
研究类型
注册 (估计的)
阶段
- 阶段2
联系人和位置
学习地点
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South Sumatera
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Palembang、South Sumatera、印度尼西亚、30128
- 招聘中
- University of Sriwijaya Palembang
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接触：
- Dian Wijayanti, dr. Dian Wijayanti, SpPD
- 电话号码：+62811-7870-993
- 邮箱：dyan.wijayanti@gmail.com
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首席研究员：
- Zainal Fahmi, dr. Zainal Fahmi, SpPD
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients diagnosed with Type 2 diabetes
- VAI values: women > 0.705, men > 1.48, or CAP values ≥ 236
- Ages 30-65 years
- Receiving standard Type 2 diabetes treatment for at least 3 months with HbA1c levels between 7% and 9.5%.
- Willing to participate in the study by signing an informed consent form.
Exclusion Criteria:
- Taking long-term steroid medication, either oral or systemic.
- Pregnant or breastfeeding women
- History of or currently suffering from an autoimmune disease
- History of or previous infection with hepatitis B or C
- ALT/AST levels > 2x ULN, eGFR < 60, or unstable heart disease.
- Regular alcohol consumption
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Proliverenol Supplementation 1000 mg with standard Therapy of DM
Participants in this arm will receive Proliverenol supplementation at a dose of 1000 mg twice daily for duration 12 weeks and standard theraphy (rapid-acting insulin three times a day, basal insulin once a day, or metformin 500 mg three times a day, or sitagliptin 50 mg twice a day, or gliclazide MR 60 mg once a day) |
This is the first study to evaluate Proliverenol specifically in patients with type 2 diabetes." |
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有源比较器：Patients receive standard of care treatment only
rapid-acting insulin three times daily, basal insulin once daily, or metformin 500 mg three times daily, or sitagliptin 50 mg twice daily, or gliclazide MR 60 mg once daily |
This is the first study to evaluate Proliverenol specifically in patients with type 2 diabetes." |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in the Visceral Adiposity Index (VAI) from baseline to week 12
大体时间：Baseline and week 12
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VAI is calculated using a formula that includes triglycerides, HDL, and body mass index. |
Baseline and week 12
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Change in HOMA-IR from baseline to week 12
大体时间：Baseline and week 12
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HOMA-IR is calculated from fasting glucose and fasting insulin levels. A higher score indicates worse insulin resistance. |
Baseline and week 12
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Change in C-Peptide from baseline to week 12
大体时间：Baseline and week 12
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C-peptide is measured through laboratory test results |
Baseline and week 12
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Change in Controlled Attenuation Parameter (CAP) from baseline to week 12
大体时间：Baseline and week 12
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CAP is measured using transient elastography to assess hepatic steatosis. |
Baseline and week 12
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in HbA1c levels from baseline to week 12
大体时间：Baseline and week 12
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HbA1c is measured through laboratory test results |
Baseline and week 12
|
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Changes in fasting glucose levels from baseline to week 12
大体时间：Baseline and week 12
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Fasting glucose is measured through laboratory test results |
Baseline and week 12
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Changes in 2-hour postprandial glucose levels from baseline to week 12
大体时间：Baseline and week 12
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2-hour postprandial glucose is measured through laboratory test results |
Baseline and week 12
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- DP04.03/DXVII.9.4/ETIK/13/2026
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
IPD 共享时间框架
Immediately following publication, with no end date
IPD 共享访问标准
The following supporting information will be made available: Study Protocol and Statistical Analysis Plan. De-identified IPD and supporting documents will be available immediately following publication, with no end date. Researchers who provide a methodologically sound proposal may request access by contacting the corresponding author and signing a data access agreement. Data will be shared for any purpose related to the approved proposal."
IPD 共享支持信息类型
- 研究方案
- 树液
- 分析代码
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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