Impaired Glucose Tolerance and Prevention of Diabetes Mellitus Type 2 by Polyherbal Formulation of Eastern Medicine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Fasting Glucose Tolerance (FGT)
研究概览
简要总结
Primary protocol to this study is to develop a natural remedy to prevent diabetes mellitus in pre-diabetic state and elaborate the effectiveness of polyherbal formulation for carrying out Phase-II, III and IV. It also aimed at to see the level of difference of glucose tolerance and impaired fasting glucose and impaired glucose tolerance between pre-diabetic and diabetic to evaluate the potential benefit for treatment of insulin resistance and sensitivity. To see the for prevention of Diabetes Mellitus (DM) and stopping / delaying the onset of DM.
详细描述
This study is a clinical trial study to evaluate the potential of prevention in pre-diabetics and to prevent onset of diabetes mellitus. For this purpose, volunteers will be enrolled in the study by observing the Helsinki Declaration for clinical trials.
volunteers will be screened for the impaired glucose tolerance or impaired fasting glucose or at risk to develop diabetes mellitus type 2.
On screening, pre-diabetics and early onset diabetics with no previous history of treatment etc will be grouped into A and B.
Biochemical evaluations will be carried out at base line and followed by three weeks intervention and evaluation of biomarkers and at sixth week for further evaluation.
Collected data will be evaluated for primary out comes and secondary out come. statistical analysis will be done. One year followup of participants was conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-59
- •Impaired Fasting Glucose (100-125mg/dl)
- •Impaired Glucose Tolerance (140-199mg/dl) 2h-75gm OGTT
- •History of Diabetes in first degree relation with one condition
- •At high risk with BMI > 35%
- •Early onset diabetic / accidental on screening (glucose >200mg/dl)
排除标准
- •on renal dialysis;
- •an acute or terminal illness or serious mental illness;
- •history of recent coronary event within the last 12 months;
- •a recent history of acute medical problem or admission to hospital;
- •any other severe medical conditions that need intervention / treatment
- •has poor short-term prognosis (expected death in <2 years);
- •is planning to travel for longer than 6 weeks during the 6-week intervention period; or
- •is with compromised liver / kidney / cardiac function
- •older patients of DM taking any form of medication / intervention
结局指标
主要结局
Fasting Glucose Tolerance (FGT)
时间窗: six weeks
enhancement of fasting glucose tolerance (\<100mg/dl)
Glucose Tolerance (GT)
时间窗: six weeks
enhancement of oral glucose tolerance (\<140mg/dl)
HB-A1c
时间窗: six week
improvement in glycated hemoglobin (HB-A1c) percentage \<6%,
次要结局
- Lipid Profile(six week)
研究者
Hafiz Abdul Sattar Hashmi
Principal Investigator
Islamia University of Bahawalpur