A Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Role of Glutathione-forming Multivitamins, Minerals with Amino Acid Formulation (Fourts B Tablets) in Preserving Beta-cell Function in Patients with Type 2 Diabetes mellitus.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in C-peptide levels from baseline to study end between the intervention and
研究概览
简要总结
Standard therapeutic strategies for T2DM focus on glycemic control through lifestyle modification and oral antidiabetic drugs.Emerging evidence suggests that certain nutritional supplements may offer ancillary benefits by modulating metabolic pathways, reducing inflammation, and supporting cellular function. Fourrts B tablets, a nutritional supplement containing essential vitamins such as B complex, minerals, and antioxidants, may improve insulin sensitivity and preserve beta cell function when used alongside standard OAD therapy. This study evaluates whether the addition of Fourrts B tablets to conventional OAD regimens can provide superior outcomes in reducing insulin resistance and improving beta-cell function, thereby offering a more holistic and sustainable approach to T2DM management.This could be a cost-effective treatment for improving clinical outcomes and slowing progression in those patients who are prone to long term complications of diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult patients between 18-70 years of age of both genders 2.Subjects with type 2 diabetes mellitus 3.Subjects willing to give written informed consent 4.HbA1c range 7-11% 5.one or two oral antidiabetic medication.
排除标准
- •1.Patients with type 1 diabetes mellitus 2.Pregnant or lactating women 3.Patients with severe chronic kidney disease 4.Patients with a history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study start 5.Patients having suffered cerebrovascular event within 3 months of start of study 6.Patients with cardiac failure categorized as Class III or IV as per New York Heart Association Functional Classification.
结局指标
主要结局
Change in C-peptide levels from baseline to study end between the intervention and
时间窗: 3 months
control arms
时间窗: 3 months
次要结局
- Change in HOMA B & HOMA IR levels(Measure Glutathione levels)
研究者
Dr V Mohan
Madras Diabetes Research Foundation