Metabolic Syndrome X
Conditions
Keywords
Metabolic syndrome, central obesity, Banaba, insulin secretion, insulin sensitivity
Brief summary
The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease. Banaba has shown evidence that has on metabolic syndrome, insulin sensitivity and insulin secretion. The investigators hypothesis was that the the administration of resveratrol modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, and lipid profile were evaluated after a 75 g of dextrose load. 12 received Banaba, 500 mg, two times per day (1000 mg) before meals during 3 months. The remaining 12 patients received placebo with the same prescription. Area Under the Curve of glucose and insulin was calculated as well as total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index). This protocol was approved by a local ethics committee and written informed consent was obtained from all volunteers. Results are presented as mean and standard deviation. Intra and inter group differences were tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 was considered significant.
Interventions
DRUGBanaba
Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
DRUGplacebo
Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
Sponsors
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients both sexes, * Age between 30 and 60 years, * Metabolic Syndrome according to the IDF criteria * Waist circumference * Man ≥90 cm * Woman ≥80 cm And two of the following criteria: * High density lipoprotein * Man ≤40 mg/dL * Woman ≤50 mg/dL * Fasting glucose ≥100 mg/dL * Triglycerides ≥150 mg/dL * Blood pressure ≥130/85 mmHg * Informed consent signed
Exclusion criteria
* Women with confirmed or suspected pregnancy * Women under lactation and/or puerperium * Hypersensibility to resveratrol * Physical impossibility for taking pills * Known uncontrolled renal, hepatic, heart or thyroid diseased * Previous treatment for the metabolic syndrome components * Body Mass Index ≥39.9 kg/m2 * Fasting glucose ≥126 mg/dL * Triglycerides ≥500 mg/dL * Total cholesterol ≥240 mg/dL * Low density lipoprotein (c-LDL) ≥190 mg/dL * Blood Pressure ≥140/90 mmHg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic Blood Pressure at Week 12 | Week 12 | The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12 |
| Systolic Blood Pressure at Week 12. | Week 12 | The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12 |
| Total Insulin Secretion at Week 12. | Week 12 | Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12. |
| Total Insulin Sensitivity at Week 12 | Week 12 | Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity at week 12. |
| Waist Circumference at Week 12 | Week 12 | Waist circumference will be evaluated at baseline and at week 12 with a flexible tape |
| First Phase of Insulin Secretion at Week 12 | Week 12 | Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. 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'), the entered values reflect the frst phase of insulin secretion at week 12. |
| Triglyceride Levels at Week 12 | Week 12 | The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques. |
| High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12 | Week 12 | The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques. |
| Fasting Glucose Levels at Week 12 | Week 12 | The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index at Week 12 | Week 12 | The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12 |
| Total Cholesterol at Week 12 | Week 12 | The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12 |
| Low-density Lipoprotein-cholesterol (LDL-C) at Week 12 | Week 12 | The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12 |
| Weight at Week 12 | Week 12 | The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12 |
Countries
Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Banaba Banaba capsules, 500mg, two times per day before meals during 90 days
Banaba: Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day. | 12 |
| Placebo Calcined magnesia capsules, 500mg, two times per day before meals during 90 days
placebo: Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Banaba | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 44.5 years STANDARD_DEVIATION 9.1 | 45.5 years STANDARD_DEVIATION 6.5 | 45 years STANDARD_DEVIATION 7.8 |
| Area under the curve (AUC) glucose | 18567.6 mg*min/dL STANDARD_DEVIATION 3480.6 | 19336.3 mg*min/dL STANDARD_DEVIATION 3224.7 | 18951.9 mg*min/dL STANDARD_DEVIATION 3352.6 |
| Area under the curve (AUC) insulin | 8445.9 uU*min/mL STANDARD_DEVIATION 2384.8 | 7669.7 uU*min/mL STANDARD_DEVIATION 2109.5 | 8057.8 uU*min/mL STANDARD_DEVIATION 2247.1 |
| Body mass index (BMI) | 28.6 kg/m^2 STANDARD_DEVIATION 2.6 | 28.6 kg/m^2 STANDARD_DEVIATION 3.8 | 28.6 kg/m^2 STANDARD_DEVIATION 3.2 |
| Body weight | 76.5 kg STANDARD_DEVIATION 11.6 | 78.8 kg STANDARD_DEVIATION 10.3 | 77.6 kg STANDARD_DEVIATION 10.9 |
| Cholesterol | 217.5 mg/dL STANDARD_DEVIATION 48.3 | 197.7 mg/dL STANDARD_DEVIATION 37.3 | 207.6 mg/dL STANDARD_DEVIATION 42.8 |
| Diastolic blood pressure | 76.5 mmHg STANDARD_DEVIATION 9.6 | 81.7 mmHg STANDARD_DEVIATION 5.5 | 79.1 mmHg STANDARD_DEVIATION 7.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 12 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| First phase of insulin secretion | 954.3 index STANDARD_DEVIATION 285.3 | 910.3 index STANDARD_DEVIATION 514.1 | 932.3 index STANDARD_DEVIATION 399.7 |
| Glucose 0' | 106.9 mg/dL STANDARD_DEVIATION 7.9 | 106.7 mg/dL STANDARD_DEVIATION 6.6 | 106.8 mg/dL STANDARD_DEVIATION 7.2 |
| Glucose 120' | 131.3 mg/dL STANDARD_DEVIATION 27.2 | 138.3 mg/dL STANDARD_DEVIATION 28.2 | 134.8 mg/dL STANDARD_DEVIATION 55.4 |
| High-density lipoprotein-cholesterol (HDL-C) | 60.8 mg/dL STANDARD_DEVIATION 18.1 | 57.3 mg/dL STANDARD_DEVIATION 20.4 | 59.0 mg/dL STANDARD_DEVIATION 19.2 |
| Insulin sensitivity | 5.2 index STANDARD_DEVIATION 1.4 | 5.1 index STANDARD_DEVIATION 2.7 | 5.1 index STANDARD_DEVIATION 2 |
| Low-density lipoprotein-cholesterol (LDL-C) | 108.1 mg/dL STANDARD_DEVIATION 39.3 | 108.0 mg/dL STANDARD_DEVIATION 35.3 | 108.0 mg/dL STANDARD_DEVIATION 37.3 |
| Region of Enrollment Mexico | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
| Systolic blood pressure | 121.5 mmHg STANDARD_DEVIATION 12.9 | 122.6 mmHg STANDARD_DEVIATION 9.6 | 122.0 mmHg STANDARD_DEVIATION 11.2 |
| Total insulin secretion | 0.4 index STANDARD_DEVIATION 0.2 | 0.4 index STANDARD_DEVIATION 0.1 | 0.4 index STANDARD_DEVIATION 0.1 |
| Triglycerides | 204.4 mg/dL STANDARD_DEVIATION 38.9 | 200.8 mg/dL STANDARD_DEVIATION 80.6 | 202.6 mg/dL STANDARD_DEVIATION 59.75 |
| Very low-density lipoprotein (VLDL) | 41.0 mg/dL STANDARD_DEVIATION 8 | 40.1 mg/dL STANDARD_DEVIATION 7.7 | 40.5 mg/dL STANDARD_DEVIATION 7.8 |
| Waist circumference | 97.0 cm STANDARD_DEVIATION 7.8 | 97.4 cm STANDARD_DEVIATION 8.8 | 97.2 cm STANDARD_DEVIATION 8.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 12 / 12 | 9 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Diastolic Blood Pressure at Week 12
The diastolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the diastolic blood pressure at week 12
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Diastolic Blood Pressure at Week 12 | 72.5 mmHg | Standard Deviation 9.2 |
| Placebo | Diastolic Blood Pressure at Week 12 | 76.5 mmHg | Standard Deviation 9.6 |
p-value: 0.254Wilcoxon (Mann-Whitney)
Primary
Fasting Glucose Levels at Week 12
The fasting glucose levels were evaluated at baseline and week 12 with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Fasting Glucose Levels at Week 12 | 103.2 mg/dL | Standard Deviation 7.4 |
| Placebo | Fasting Glucose Levels at Week 12 | 104.2 mg/dL | Standard Deviation 8.9 |
p-value: 0.034Wilcoxon (Mann-Whitney)
Primary
First Phase of Insulin Secretion at Week 12
Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. 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'), the entered values reflect the frst phase of insulin secretion at week 12.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | First Phase of Insulin Secretion at Week 12 | 913.9 index | Standard Deviation 490.3 |
| Placebo | First Phase of Insulin Secretion at Week 12 | 651.0 index | Standard Deviation 405.2 |
p-value: 0.799Wilcoxon (Mann-Whitney)
Primary
High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12
The HDL-C levels will be evaluated at week 12 with enzymatic/colorimetric techniques.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12 | 56.4 mg/dL | Standard Deviation 11.2 |
| Placebo | High Density Lipoprotein-cholesterol (HDL-C) Levels at Week 12 | 58.4 mg/dL | Standard Deviation 16 |
p-value: 0.53Wilcoxon (Mann-Whitney)
Primary
Systolic Blood Pressure at Week 12.
The systolic blood pressure was evaluated at baseline and week 12 with a digital sphygmomanometer and the entered values reflect the systolic blood pressure at week 12
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Systolic Blood Pressure at Week 12. | 116.3 mmHg | Standard Deviation 9.8 |
| Placebo | Systolic Blood Pressure at Week 12. | 122.6 mmHg | Standard Deviation 13.1 |
p-value: 0.05Wilcoxon (Mann-Whitney)
Primary
Total Insulin Secretion at Week 12.
Measure Description: The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔAUC insulin/ΔAUC glucose), the entered values reflect the total insulin secretion at week 12.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Total Insulin Secretion at Week 12. | 0.3 index | Standard Deviation 0.2 |
| Placebo | Total Insulin Secretion at Week 12. | 0.3 index | Standard Deviation 0.1 |
p-value: 0.047Wilcoxon (Mann-Whitney)
Primary
Total Insulin Sensitivity at Week 12
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. The entered values reflect the insulin sensitivity at week 12.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Total Insulin Sensitivity at Week 12 | 5.1 index | Standard Deviation 3.2 |
| Placebo | Total Insulin Sensitivity at Week 12 | 5.5 index | Standard Deviation 2.3 |
p-value: 0.878Wilcoxon (Mann-Whitney)
Primary
Triglyceride Levels at Week 12
The triglycerides will be evaluated at week 12 with enzymatic-colorimetric techniques.
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Triglyceride Levels at Week 12 | 148.0 mg/dL | Standard Deviation 43 |
| Placebo | Triglyceride Levels at Week 12 | 199.9 mg/dL | Standard Deviation 101.9 |
p-value: 0.021Wilcoxon (Mann-Whitney)
Primary
Waist Circumference at Week 12
Waist circumference will be evaluated at baseline and at week 12 with a flexible tape
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Waist Circumference at Week 12 | 95.7 cm | Standard Deviation 7.9 |
| Placebo | Waist Circumference at Week 12 | 97.0 cm | Standard Deviation 7.8 |
p-value: 0.919Wilcoxon (Mann-Whitney)
Secondary
Body Mass Index at Week 12
The Body Mass index was calculated at baseline and at week 12 with the Quetelet index and the entered values reflect the body mass index at week 12
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Body Mass Index at Week 12 | 28.4 kg/m^2 | Standard Deviation 2.7 |
| Placebo | Body Mass Index at Week 12 | 28.9 kg/m^2 | Standard Deviation 5.7 |
p-value: 0.227Wilcoxon (Mann-Whitney)
Secondary
Low-density Lipoprotein-cholesterol (LDL-C) at Week 12
The LDL-C levels were measured at baseline and at week 12 with standardized techniques and the entered values reflect the c-LDL levels at week 12
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Low-density Lipoprotein-cholesterol (LDL-C) at Week 12 | 29.0 mg/dL | Standard Deviation 8 |
| Placebo | Low-density Lipoprotein-cholesterol (LDL-C) at Week 12 | 39.9 mg/dL | Standard Deviation 20.3 |
p-value: 0.021Wilcoxon (Mann-Whitney)
Secondary
Total Cholesterol at Week 12
The total cholesterol was estimated by standardized techniques at baseline and week 12 and the entered values reflect the total cholesterol level at week 12
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Total Cholesterol at Week 12 | 210.0 mg/dL | Standard Deviation 39.6 |
| Placebo | Total Cholesterol at Week 12 | 201.7 mg/dL | Standard Deviation 34.8 |
p-value: 0.41Wilcoxon (Mann-Whitney)
Secondary
Weight at Week 12
The weight was measured at baseline and week 12 with a bioimpedance balance and the entered values reflect the weight at week 12
Time frame: Week 12
Population: All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Banaba | Weight at Week 12 | 72.6 kg | Standard Deviation 8.6 |
| Placebo | Weight at Week 12 | 72.2 kg | Standard Deviation 8.1 |
p-value: 0.347Wilcoxon (Mann-Whitney)