placebo tablet twice a day twenty minutes before main meals, for 12 weeks,

nutraceutical oral capsule 920 mg twice a day for 12 weeks

Diabetes Mellitus, Type 2

Nutritional and Metabolic Diseases

Vascular System Injury

Therapy-Related Morphologic Change

nutraceutical 920 mg (Bergamot 450 mg, Gymnema (400 mg, Phaseolamine 30 mg, Olea Europaea 10 mg) twice day , 12 weeks

Nutriceutical Oral Capsule,

Placebo Oral Tablet

Capomolla Antonio

Efficacy and Safety of Nutraceuticals in Patients With Diabetes Mellitus Type II and Dyslipidemia.

Efficacy and Safety of Nutraceuticals (Bergamot 450 mg, Gymnema (400 mg, Phaseolamin 30 mg, Olea Europaea 10 mg) in Patients With Diabetes Mellitus Type II and Dyslipidemia.

Division Director

Villa dei Gerani

University Magna Graecia

Experimental drawing Phase II prospective, randomized, comparative, vs placebo study

600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.

600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

Placebo

600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

Gymnema Sylvestre

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Region of Enrollment

The BW was evaluated after an overnight fast, through a bioimpedance digital scale results are reported in kilograms with a decimal.

Body weight (BW)

The BMI was calculated by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.

Body mass index (BMI)

The WC was evaluated after an overnight fast with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.

Waist circumference (WC)

The SBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of SBP. The value was expressed on mmHg.

Systolic blood pressure (SBP)

The DBP was evaluated with a digital sphygmomanometer with the subject sited down on a chair after a resting period of 5 minutes on three occasions. The mean of the three measures was considered as the value of DBP. The value was expressed on mmHg.

Diastolic blood pressure (DBP)

The blood sample for determining of TGs, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Triglycerides (TGs)

The blood sample for determining of TC, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Total cholesterol (TC)

The blood sample for determining of HDL-C, was taken after an overnight fast and was evaluated by colorimetric method. The value was expressed on mmol/L.

high-density lipoprotein cholesterol (HDL-C)

The blood sample for determining of LDL-C, was taken after an overnight fast and was calculated by Friedewald formula. The value was expressed on mmol/L.

Low-density lipoprotein cholesterol (LDL-C)

The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5 . The value was expressed on mmol/L.

Very-low density lipoprotein (VLDL)

The blood sample for determining of FPG, was taken after an overnight fast and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

Fasting plasma glucose (FPG)

The blood sample for determining of 2-h PG, was taken two hours after the ingestion of the drink with 75 g dextrose and was evaluated by spectrophotometry method. The value was expressed on mmol/L.

2-hour postload plasma glucose (2-h PG)

The estimation for AUCG was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed mmol/L/min.

Area under the curve of glucose (AUCG)

The estimation for AUCI was calculated from parameters obtained during the 2 hours oral glucose tolerant test (OGTT) with 75 g dextrose by trapezoidal integration. The value was expressed on pmol/L/min.

Area under the curve of insulin (AUCI)

Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose).

Total insulin secretion

First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').

First phase of insulin secretion

Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].

Insulin sensitivity

Waist Circumference (WC)

High-density Lipoprotein Cholesterol (HDL-C)

Fasting Plasma Glucose (FPG)

Systolic Blood Pressure (SBP)

Diastolic Blood Pressure (DBP)

The total insulin secretion was calculated by the insulinogenic index (ΔABC insulin / ΔABC glucose).

Total Insulin Secretion

The first phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0').

First Phase of Insulin Secretion

The insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)].

Insulin Sensitivity

Body Weight (BW)

Body Mass Index (BMI)

Total Cholesterol (TC)

Low-density Lipoprotein Cholesterol (LDL-C)

The blood sample for determining the VLDL, was taken after an overnight fast and was calculated as triglycerides/5. The value was expressed on mmol/L.

Very-low Density Lipoprotein (VLDL)

2-hour Postload Plasma Glucose (2-h PG)

Area Under the Curve of Glucose (AUCG)

Area Under the Curve of Insulin (AUCI)

Overall Study

Dra. Esperanza Martínez Abundis

Metabolic Syndrome

Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

gymnema/triglyceride

Efficacy and Safety of Nutraceuticals in Patients With Diabetes Mellitus Type II and Dyslipidemia.

Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

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