Prospective study of the metabolic efficacy of Metformin in non-obese patients with type 2 diabetes mellitus
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in fasting plasma glucose, 2 hour plasma glucose after 75 gm oral glucose glucose and HbA1c
研究概览
简要总结
| Brief Summary |
This study is a open label study to assess the efficacy of Metformin in patients who are diagnosed to have type 2 diabetes mellitus in non obese Indians who have ideal body weight ie, 18 to 23 kg/ m2 .
Exclusion criteria
Individuals who have renal impairment, s creatinine >1.4 mg/dl in women and 1.5 mg/dl in males, who have liver disease, both chronic and acute, and who have active infection.
All individuals more than 65 years also will be excluded.
Individuals who are already intolerant to metformin and who requires emergency control of hyperglycemia due to their co morbid condition will also be not included in the study.
The enrolled individuals will be put on medical nutrition therapy and advised to maintain regular exercise. The compliance will be checked using food frequency questionnaire.
The individuals who fulfill the criteria will have their baseline investigations done, which include-
-
HbA1c
-
Plasma glucose, insulin and C peptides in the fasting state, 30, 60, 90 and 120 minutes of 75 gm glucose intake
-
fasting serum lipid profile, serum creatinine, SGPT and C reactive protein
-
urine microalbumin and a baseline fundus examination to rule out any complications related to diabetes.
Dose of metformin in this study
After 3 months of lifestyle modification, if the HbA1c is > 7% or Fasting plasma sugars >140 or 2 hr plasma glucose >200 mg/dl , they will be started on Metformin 500 mg twice daily per orally.
Primary outcome
The changes metformin bring in HbA1c, fasting and post prandial plasma sugars at the completion of 6 months of Metformin therapy will be the primary outcome studied.
Secondary outcome
The secondary outcome to be studied includes changes in serum fasting lipid profile and CRP.
Adverse effects including the weight loss, gastrointestinal problems and anorexia will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals should have type 2 Diabetes Mellitus 2)Duration of disease less than 5 years 3)Body mass index less than 23 kg per meter square 4)Glycosylated Hemoglobin more than 7% 5)Fasting plasma glucose more than 140 mg/dl 6)Post prandial sugar more than 200 mg/dl.
排除标准
- •Age less than 18 years and more than 65 years 2)Duration of Diabetes Mellitus more than 5 years 3)Body mass index more than 23 kg per meter square 4)Glycosylated Hemoglobin less than 7% and more than 10 % 5)Fasting plasma glucose less than 140 and more than 200 mg/dl 6)Post prandial sugar less than 200 mg/dl and more than 300 mg/dl 7)Serum creatinine more than 1.4 mg/dl in females and more than 1.5 mg/dl in males or urine albumin more than 300 mg/ 24 hours 8)Patients with acute or chronic liver disease 9)Patients with secondary cause for diabetes 10)Patients who are on drugs which can affects the glucose homeostasis 11)Pregnant and lactating mothers.
结局指标
主要结局
change in fasting plasma glucose, 2 hour plasma glucose after 75 gm oral glucose glucose and HbA1c
时间窗: at baseline and after 3 months of treatment with Metformin
次要结局
- change in fasting serum lipid profile and CRP(0 and 3 months)