Cardiovascular Risk assessment and Nutritional modulation in 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
- 20
- 试验地点
- 1
- 主要终点
- Reduction in diabetic profile such as RBS in mg/dl, FBS in mg/dl, PPBS in mg/dl and HbA1c in %
研究概览
简要总结
This is a single-arm intervention study. A total of 20 subjects of both genders who meet inclusion criteria will be recruited, and a disease-specific functional food formulation will be given orally to patients with type 2 diabetes mellitus for a period of 90 days. The clinical and metabolic outcomes of patients will be analyzed before and after the intervention. The functional food formulation was developed by using locally available ingredients, which are cost-effective and functional foods. Recruitment of the subjects will be conducted in the health center of the University of Mysore, Mysore district. The primary outcome and the secondary outcome will be measured using anthropometric measurements, biochemical parameters, clinical signs and symptoms, dietary data, and a multifrequency analyzer for body composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 74.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with T2DM, who are in the age range of 25–74 years of both genders, who are attending the PHC of UOM, Mysore, will be included in the study.
排除标准
- •Subjects with known cardiovascular problems, who are on anti-inflammatory drugs, with any known metabolic disorder, Subjects who are pregnant with gestational diabetes and lactating mothers, one who does not give consent?, Patients who were critically ill.
结局指标
主要结局
Reduction in diabetic profile such as RBS in mg/dl, FBS in mg/dl, PPBS in mg/dl and HbA1c in %
时间窗: RBS, FBS and PPBS will be tested at baseline, 4th weeks, 8th weeks & 12th weeks. HbA1c will be estimated at baseline and 12th weeks.
次要结局
- Improvement in HS_CRP in mg/L, Hcy in micro mol/L, Total cholesterol in mg/dl, HDLC in mg/dl, Triglycerides in mg/dl, LDLC in mg/dl, VLDLC in mg/dl, Body composition multifrequency analyzer by using (Inbody 770) , BMI in kg/m2 & WHR in %(will be tested or analyzed at baseline & 12th weeks.)
研究者
Puneetha P
Department of studies in Food Science and Nutrition