Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

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СтатусЗавршено

Спонзори

University of Guadalajara

КЛИНИЧКО ИСПИТИВАЊЕ: NCT02370121

BioSeek: nct02370121

Кључне речи

Апстрактан

Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.

Опис

A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

Датуми

Последња верификација:	05/31/2019
Фирст Субмиттед:	02/16/2015
Предвиђена пријава послата:	02/22/2015
Прво објављено:	02/23/2015
Послато последње ажурирање:	06/07/2019
Последње ажурирање објављено:	06/17/2019
Датум првог достављања резултата:	03/26/2016
Датум првог подношења резултата КЦ:	04/26/2016
Датум првог објављивања резултата:	06/02/2016
Стварни датум почетка студије:	01/31/2013
Процењени датум примарног завршетка:	11/30/2014
Предвиђени датум завршетка студије:	12/31/2014

Стање или болест

Metabolic Syndrome

Интервенција / лечење

Drug: Placebo

Drug: Gymnema Sylvestre

Фаза

Фаза 2

Групе руку

Арм	Интервенција / лечење
Placebo Comparator: 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.	Drug: Placebo Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
Experimental: Gymnema Sylvestre 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.	Drug: 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.

Критеријуми

Узраст подобан за студирање	30 Years До 30 Years
Полови подобни за студирање	All
Прихвата здраве волонтере	да
Критеријуми	Inclusion Criteria: - Letter of consent and release signed by each patient - Body mass index: 25-34.99 kg/m2 - Body weight without variations above or under 5% during the three months prior to the study - Diagnostic of metabolic syndrome according to the modified International Diabetes Federation definition: Central obesity (defined as waist circumference ≥ 80 cm in women and ≥ 90 cm in men) Plus any two of the following four factors: - Triglycerides: 150-499 mg/dL. - High density lipoprotein: Woman < 50 mg/dL, man < 40 mg/dL. - Blood pressure systolic:130-139 mmHg and/or Blood pressure diastolic: 85-89 mmHg - Fasting glucose: 100-125 mg/dL Exclusion Criteria: - Type 1 or 2 diabetes mellitus - Previous pharmacological treatment for components of metabolic syndrome - Mental or physical illness interfering with the study - Thyroid or cardiovascular disease - Pregnant or suspected pregnant women - Woman breastfeeding - Index of body mass: ≥ 35 kg/m2 - Treatments known to affect metabolism of glucose, fats and affecting arterial tension - Patients with hepatic or renal diseases background - Patients diagnosed with kidneys disease - Calcined magnesium intolerance - Gymnema Sylvestre intolerance

Исход

Примарне мере исхода

1. Waist Circumference (WC) [Week 12]

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.

2. Triglycerides (TGs) [week 12]

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.

3. High-density Lipoprotein Cholesterol (HDL-C) [Week 12]

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.

4. Fasting Plasma Glucose (FPG) [week 12]

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.

5. Systolic Blood Pressure (SBP) [week 12]

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.

6. Diastolic Blood Pressure (DBP) [week 12]

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.

7. Total Insulin Secretion [Week 12]

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

8. First Phase of Insulin Secretion [week 12]

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').

9. Insulin Sensitivity [week 12]

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)].

Секундарне мере исхода

1. Body Weight (BW) [week 12]

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

2. Body Mass Index (BMI) [week 12]

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.

3. Total Cholesterol (TC) [week 12]

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.

4. Low-density Lipoprotein Cholesterol (LDL-C) [Week 12]

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.

5. Very-low Density Lipoprotein (VLDL) [week 12]

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.

6. 2-hour Postload Plasma Glucose (2-h PG) [week 12]

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.

7. Area Under the Curve of Glucose (AUCG) [week 12]

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.

8. Area Under the Curve of Insulin (AUCI) [week 12]

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.

Effect of Gymnema Sylvestre on Metabolic Syndrome and Insulin

Кључне речи

triglyceride

insulin resistance

hyperlipidemias

dyslipidemias

гојазност

аланин

креатинин

gymnema

gymnema sylvestre