Clinical Evaluation of Fenugreek Seed Extract In Patients With Type- 2 Diabetes: An Add-On Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 154
- 主要终点
- Post prandial blood sugar levels
研究概览
简要总结
Trigonella Foenum-Graecum, commonly known as Fenugreek, is a plant that has been extensively used as a source of anti-diabetic compounds Fenugreek is traditionally used in India, especially in the Ayurvedic and Unani systems.
Preliminary animal and human trials suggest possible hypoglycemic and anti-hyper lipidemic properties of Fenugreek seed powder, when taken orally. Fenugreek seeds contain 50% fiber (30% soluble fiber and 20% insoluble fiber) that can slow the rate of post-prandial glucose absorption. This may be a secondary mechanism for the hypoglycemic effect.
详细描述
Diabetes mellitus is a complex heterogeneous group of metabolic conditions characterized by increased levels of blood glucose due to impairment in insulin action and/or insulin secretion. Diabetes is a condition primarily defined by the level of hyperglycemia giving rise to risk of microvascular damage (retinopathy, nephropathy and neuropathy). It is associated with reduced life expectancy, significant morbidity due to specific diabetes related Microvascular complications, increased risk of macrovascular complications (ischemic heart disease, stroke and peripheral vascular disease), and diminished quality of life.Type 2 diabetes mellitus (T2DM) is the most common form of diabetes in humans and results from a combination of genetic and acquired factors that impair -cell function and tissue insulin sensitivity.
The WHO has put the number of persons with diabetes worldwide at approximately 170 million. The prevalence of diabetes mellitus has risen dramatically over the past 20 years, and the number of people with diabetes is expected to reach 366 million by 2025. The prevalence of type 2 diabetes mellitus is expected to grow even more rapidly in the future. There is also considerable geographic variation in the incidence of T2DM, and countries like India are fast emerging as ''diabetes hot spots". About 5-10% of the total health care budget has been used for T2DM in many countries.
Reduced pancreatic β-cell functional mass in diabetes, and other categories of glucose intolerance, has been described by several authors, and decreased islet and/or -cell volume in the pancreas of type 2 diabetic patients has been consistently reported. In addition, studies conducted in patients, and isolated islets, have shown both quantitative and qualitative defects of glucose-stimulated insulin secretion.
The ideal antidiabetic agent should normalize plasma glucose, minimize side effects, and prevent development of micro- and macrovascular complications. Obviously no such agent is available, nor is it likely to be available in the near or medium-term future.
Current treatments and treatment regimens include combinations of oral antidiabetic drugs (OADs), antihypertensive medications, and antidyslipidemic agents, but these have been less than successful in managing their respective disease targets with clinical goals. Measures such as screening and intensive life-style modification can help to delay the onset of diabetes in at-risk individuals, and stringent glycemic control with pharmacotherapy may improve outcomes. To manage the type 2 diabetes epidemic effectively, however, agents that can effectively and durably controls glycemia while providing pleiotropic benefits (e.g. blood pressure reduction) are required.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Either gender & Attending diabetic clinical at hospital
- •Type-2 DM <5 years duration
- •On oral hypoglycaemic agents( Metformin±Sulfonylurea)
- •No change in anti-diabetic treatment for the last one month
- •HbA1c >7.5%
- •Fasting plasma glucose not exceeding 180mg/dL
- •Patient able to make proper use of medication.
- •Patients willing to provide signed informed consent
排除标准
- •Diabetes other than type 2 diabetes mellitus
- •Evidence of renal disease (Serum creatinine > 1.5mg/ml)
- •Evidence of liver disease (aspartate transaminase (AST) and alanine transaminase (ALT) >3 times of normal)
- •Pregnant and lactating mothers and women intending pregnancy
- •Participation in any other clinical trial with in the last 30 days
- •History of any hemoglobinopathy that may affect determination of Glycosylated Haemoglobin
- •Treatment with oral anti-diabetic agents (other than Metformin or SU) during the 12 weeks before baseline visit.
- •History of intolerance or hypersensitivity to sulfonylurea or Metformin or Fenugreek seed extract.
- •Any condition which in the opinion of the PI is significant and can make the patient unsuitable for study or can place it under additional risk.
结局指标
主要结局
Post prandial blood sugar levels
时间窗: 12 weeks
Reduction in post prandial blood sugar levels (mg/dL)
Fasting blood sugar levels
时间窗: 12 weeks
Reduction in fasting blood sugar levels (FBS) (mg/dL)
次要结局
- Glycosylated haemoglobin (HbA1C)(%)(12 weeks)