To Study the Effects of Mango Ingestion in T2DM and Non-diabetic Subjects.
Condition: Normoglycemia; T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      T2DM patient will be recruited from endocrine OPD

        1. Clinical History and Examination:

             1. General Physical Examination:

                  -  Height (cm)

                  -  weight (kg)

                  -  BMI (kg/m2)

                  -  Blood Pressure (mmHg)

             2. 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)

             3. 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)

        2. 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

        3. Body Composition Analysis (TANITA)
    

Detailed description: 
      1. 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.

           Procedure for Phase II:

             1. Continuous glucose monitoring system (CGMS): It will be affixed for 3 days.

             2. The research team will be contacting the study subjects every day for any
                discomfort due to CGMS device or diet.

             3. On day 4 study subjects will be called to the study site and CGMS will be removed
                and data will be transferred to the study records.

             4. Study subjects will be asked to maintain a food diary and record the foods consumed
                during the entire period of 3 days.

             5. The subjects will also be asked to fill questionnaire of dietary assessment on Day
                1 and Day 4 for per schedule of assessments.

        3. Phase III: Confirmatory Chronic Phase- Randomized controlled parallel arm study

             -  Study population: patients with T2DM, n=35

             -  Study groups: 2 groups; mango (n=20), bread (n=15) Subjects in mango group will be
                further randomized into two different groups. Each group will be tested on a
                different variety of mango.

      Procedure for Phase III:

      Subjects will be given glucometers and will be asked to monitor blood glucose at fasting
      state and after standard breakfast meal at baseline, at day 30 and day 60 in both the study
      groups. The intermediate term effect of mango consumption and bread consumption will be
      assessed at baseline and at day 60 in terms of following investigations:

        1. Dietary assessment

        2. Physical activity (PA) assessment (GPAQ)

        3. Blood pressure

        4. Anthropometry measures

        5. Body composition

        6. Biochemical investigations
    

Intervention name(s): Bread; Mango
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 81g (3 slices) harvest gold white bread as standard food.; 250g of mango pulp of each mango variety was given to the subjects.
Other intervention name(s): Safeda, Dushehri, Langra
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Patients with T2DM and non-diabetic subjects were randomized into two food groups- mango and bread for 3 days, then after a 7 days washout period, the cross-over took place.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Insulin resistance; body composition; glycemic index