A Randomized Controlled Study to Compare Effects of Mango Ingestion on Glycemia (Glycemic Response, Continuous Glucose Monitoring and Fructosamine) Insulin Resistance and Body Composition in Patients With T2DM and Non-diabetic Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Outcome for all the phases will be as follows
研究概览
简要总结
T2DM patient will be recruited from endocrine OPD
-
Clinical History and Examination:
-
General Physical Examination:
- Height (cm)
- weight (kg)
- BMI (kg/m2)
- Blood Pressure (mmHg)
- Anthropometry: Circumferences and skinfold thickness will be recorded for the patients in the following manner.
Circumferences:
- Waist circumference (cm)
- Hip circumference (cm)
- Mid-arm circumference (cm)
- Mid-thigh circumference (cm)
- Skin fold thickness: Skin fold thickness will be measured by using (LANGE skin fold calipers) (to nearest of 1 mm) at the following sites
- Biceps (mm)
- Triceps (mm)
- Thigh (mm)
- Calf (mm)
- Sub scapular (mm)
- Supra-iliac (mm)
- Anterior axillary fold. (mm)
- Biochemical Test: The biochemical analysis will be done using ELISA kit or commercially available kits
- Blood glucose (mg/dL)
- HbA1c (%)
- Serum insulin (μIU/mL)
- Total Cholestrol (mg/dl)
- Triglyceride (mg/dl)
- Fructosamine (umol/L)
- Adiponectin (µg/ml) -- HOMA-IR
- Body Composition Analysis (TANITA)
详细描述
- Phase I: Exploratory Acute Phase- Stratified randomized study
- Study population: 2 groups; patients with T2DM and non-diabetic subjects n=45 (20 T2DM subject, 25 non-diabetic subjects).
- Study groups: 3 groups; OGTT (n=5), mango (n=30), bread (n=10) Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango.
Procedure for Phase I:
After measuring baseline glucose level on empty stomach, three groups will be given their respective standardized food item and blood samples will be drawn every half an hour upto 2 hours of ingestion at (minutes): 0, 30, 60, 90 and 120. Fingertip capillary blood will be used for the estimation of blood glucose using a glucometer of contour brand. 2. Phase II: Exploratory Sub-Acute Phase- Two randomized cross over study
- Study population: 2 groups; patients with T2DM and non-diabetic subjects, n=50 (25 in each study population group)
- Study groups: 2 groups; mango (n=30), bread (n=20) Subjects in mango group will be further randomized into three different groups. Each group will be tested on a different variety of mango.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Patients were recruited from Fortis C-DOC OPD.
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
- •For patients with diabetes: Stable glycemic control on metformin or sulfonylurea for past 3 months and without any major complications and HbA1C less than 8%
排除标准
- •Acute infections and advanced end-organ damage
- •History of hepatitis or pancreatitis, abnormal liver and renal functions
- •Recent (<3 months) changes in weight
- •Any known allergy to mangoes and bread
- •Subjects with hypothyroidism
- •On any drug causing weight gain or weight loss.
结局指标
主要结局
Outcome for all the phases will be as follows
时间窗: Baseline, after six months of intervention
Fasting glucose (mg/dL)
Postprandial blood glucose (mg/dL)
时间窗: Baseline, after six months of intervention
Glycemic indices as per Continuous glucose monitoring system (CGMS) & HbA1c (%)
时间窗: Baseline, after six months of intervention
次要结局
未报告次要终点
研究者
Dr Anoop Misra
Director
Diabetes Foundation, India