Clinical trial NCT06055582: To Study the Effects of Mango Ingestion in T2DM and Non-diabetic Subjects.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normoglycemia
T2DM (Type 2 Diabetes Mellitus)
Keywords: Insulin resistance
body composition
glycemic index
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2023-09-26
Enrollment: 130
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

-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%

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Outcome for all the phases will be as follows
timeFrame: Baseline, after six months of intervention
measure: Postprandial blood glucose (mg/dL)
timeFrame: Baseline, after six months of intervention
measure: Glycemic indices as per Continuous glucose monitoring system (CGMS) & HbA1c (%)
timeFrame: Baseline, after six months of intervention
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Fortis CDOC Hospital
state: Delhi
Study officials:
affiliation: Fortis CDOC Hospital
name: Anoop Misra, MD
role: PRINCIPAL_INVESTIGATOR
References: