Effect of Millet Supplementation On Anthropometric Indices, Biochemical, Inflammatory and Body Composition Indices in Patients with Prediabetes and Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- • Lipid profile
研究概览
简要总结
This project will evaluate the effect of finger millet in pre-diabetics, newly diagnosed diabetics and diabetic already on treatment. Apart from providing nutrition, Finger Millet is low in carbohydrate having low glycaemic index, it counters insulin resistance, and also helpful in dyslipidaemia, fatty liver and cardiovascular manifestations which are the late sequel of diabetes mellitus.
The study is Randomized, Single Blind, Multi- Arm Intervention Study. The participants will be taken from OPD and IPD patients of the department of Ilaj-bit-Tadbeer of Ajmal Khan Tibbiya College and Hospital and Rajiv Gandhi Centre for Diabetes and Endocrinology, JNMCH, AMU, Aligarh will be included in the study on the basis of inclusion and exclusion criteria and diagnosed by subjective and objective parameters as mentioned in the protocol. The diagnosed patients will be divided into four groups with 100 patients in each group-
GROUP 1 –Pre diabetes
GROUP 2 - Type 2 Diabetes Mellitus (Newly diagnosed)
GROUP 3 – Type 2 Diabetes Mellitus (on treatment)
GROUP 4 – Type 2 Diabetes Mellitus (conventional diet)
All the four groups will be given same intervention. Finger millet flour will be provided to the patients in the quantity of 100 gm divided in two doses of 50 gm each in the form of chapatti/tortilla to be taken twice (lunch & dinner) a day for 6 months and follow-up after twice in 3 months. All results will be analyzed statistically & will be discussed in detail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
入选标准
- •o Diagnosed patients of prediabetes and Diabetes.
- •o Age 18-65 years, both Genders.
- •o HbA1c: 5.7 % and above.
- •o Fasting BSL: 100 mg/dl and above.
- •o PP BSL/ Impaired Glucose Intolerance: 140 mg/dl and above.
- •o Patients who agree to sign informed consent and follow the protocol.
排除标准
- •o Pregnancy and lactation.
- •o Patients below the age of 18 and above the age of 65 years.
- •o Blood sugar level beyond the inclusion limits.
- •o Patients with systemic disorders like chronic renal failure and coronary artery disease.
- •o Patients who refuse to sign written consent.
结局指标
主要结局
• Lipid profile
时间窗: 6 Months
• USG Abdomen
时间窗: 6 Months
PRIMARY OUTCOMES MEASURES-
时间窗: 6 Months
• FBS
时间窗: 6 Months
• PPBS
时间窗: 6 Months
• HBA1C
时间窗: 6 Months
• BMI
时间窗: 6 Months
• Body Weight
时间窗: 6 Months
• Body composition
时间窗: 6 Months
• HOMA-Insulin Resistance Test
时间窗: 6 Months
次要结局
- SECONDARY OUTCOMES MEASURES-(• Serum Calcium)
- SUBJECTIVE PARAMETERS-(1-Polydipsia)
研究者
Asia Sultana
Aligarh Muslim University
