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Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion

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ClinicalTrials.gov Identifier: NCT02114892
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : December 29, 2014
Last Update Posted : December 7, 2016
Sponsor:
Information provided by (Responsible Party):
Manuel González Ortiz, University of Guadalajara

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Metabolic Syndrome X
Interventions: Drug: Resveratrol
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Resveratrol

Resveratrol capsules, 500 mg, three times per day before meals during 90 days

Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.
Placebo

Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days

Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg

Participant Flow:   Overall Study
    Resveratrol   Placebo
STARTED   12   12 
COMPLETED   11 [1]   10 [2] 
NOT COMPLETED   1   2 
Lost to Follow-up                1                2 
[1] One patient did not complete the study due to early withdrawl
[2] Two patients did not complete the study due to early withdrawl



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Sample size was calculated in accordance of Jeyaseelan’s clinical trial formula with a statistical confidence of 95%, statistical power of 80%, obtaining a total of 12 patients per group including 20% of expected loss.

Reporting Groups
  Description
Resveratrol

Resveratrol capsules, 500 mg, three times per day before meals during 90 days

Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.
Placebo

Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days

Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
Total Total of all reporting groups

Baseline Measures
   Resveratrol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 12   12   24 
Age 
[Units: Years]
Mean (Standard Deviation) 		 39.75  (5.38)   40.33  (5.41)   40.04  (5.29) 
Gender 
[Units: Participants]
Count of Participants 		     
Female      10  83.3%      7  58.3%      17  70.8% 
Male      2  16.7%      5  41.7%      7  29.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants 		     
Hispanic or Latino      12 100.0%      12 100.0%      24 100.0% 
Not Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
 		     
Mexico   12   12   24 
Body weight [1] 
[Units: Kg]
Mean (Standard Deviation) 		 94.4  (13.2)   91.0  (10.7)   92.71  (11.90) 
[1] Body weight was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal.
Height [1] 
[Units: Cm]
Mean (Standard Deviation) 		 162.67  (7.2)   164.33  (7.2)   163.50  (7.1) 
[1] Height was measured with subjects standing and the measurements were round to the nearest centimeter.
Body mass index (BMI) 
[Units: Kg/m2]
Mean (Standard Deviation) 		 35.56  (3.2)   33.73  (3.7)   34.65  (3.5) 
Fat Mass [1] 
[Units: Kg]
Mean (Standard Deviation) 		 41.18  (7.9)   36.13  (9.2)   38.66  (8.8) 
[1] Fat mass was evaluated through a bioimpedance digital scale and results are reported in kg with a decimal
Waist circumference [1] 
[Units: Cm]
Mean (Standard Deviation) 		 109.83  (9.3)   104.50  (8.5)   107.17  (9.1) 
[1] Waist circumference was measured with a flexible tape in the midpoint between the lowest rib and the iliac crest and is expressed in centimeters.
Systolic blood pressure [1] 
[Units: mmHg]
Mean (Standard Deviation) 		 119.96  (13.1)   116.03  (13.2)   117.99  (13.0) 
[1] Blood pressure 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 systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg
Diastolic blood pressure [1] 
[Units: mmHg]
Mean (Standard Deviation) 		 78.36  (8.7)   77.15  (8.4)   77.76  (8.4) 
[1] Blood pressure 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 systolic blood pressure (SBP) and diastolic (DBP). The value was expressed on mmHg
Glucose 0' [1] 
[Units: Mmol/l]
Mean (Standard Deviation) 		 4.8  (0.6)   5.1  (0.4)   4.95  (0.5) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2500 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 30' [1] 
[Units: Mmol/l]
Mean (Standard Deviation) 		 8.5  (1.8)   8.4  (1.1)   8.4  (1.4) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 60' [1] 
[Units: Mmol/l]
Mean (Standard Deviation) 		 9.0  (2.7)   9.3  (1.8)   9.1  (2.2) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 90' [1] 
[Units: Mmol/l]
Mean (Standard Deviation) 		 8.3  (2.3)   8.0  (1.8)   8.2  (2.0) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Glucose 120' [1] 
[Units: Mmol/l]
Mean (Standard Deviation) 		 6.5  (1.7)   6.9  (2.2)   6.7  (1.9) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood samples were taken at the basal and at the minutes 30, 60, 90 and 120 after a 75 g oral dextrose load. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Cholesterol [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 206.0  (32.0)   195.4  (34.8)   200.7  (33.1) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
Triglycerides [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 254.3  (55.6)   233.8  (77.7)   244.0  (66.9) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
HDL-c [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 37.3  (3.7)   37.9  (7.7)   37.6  (5.9) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
LDL-c [1] 
[Units: mg/dL]
Mean (Standard Deviation) 		 120.7  (32.0)   119.8  (46.5)   120.2  (39.0) 
[1] The blood samples were taken after the insertion of a catheter as an open path to facilitate the procedure. Blood was centrifuged at 2000 rpm and serum was separated into two aliquots: the first was immediately analyzed to determine glucose, lipid profile, hepatic enzymes, creatinine and uric acid.
AUC glucose [1] 
[Units: mmol*h/L]
Mean (Standard Deviation) 		 935.8  (188.6)   950.8  (167.6)   943.3  (174.6) 
[1] Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.
AUC insuline [1] 
[Units: pmol*h/L]
Mean (Standard Deviation) 		 48418.5  (22707.4)   62955.8  (37620.0)   55687.1  (31282.6) 
[1] Area under the curve (AUC) of glucose and insulin was calculated with the polygonal formula.
Total insulin secretion [1] 
[Units: Unitless]
Mean (Standard Deviation) 		 0.48  (0.22)   0.59  (0.29)   0.54  (0.26) 
[1] Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin / ΔABC glucose).
First phase of insulin secretion [1] 
[Units: Unitless]
Mean (Standard Deviation) 		 1256.6  (601.5)   1440.0  (619.8)   1348.3  (604.6) 
[1] 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’)
Insulin sensitivity [1] 
[Units: Unitless]
Mean (Standard Deviation) 		 3.5  (1.5)   3.3  (1.5)   3.4  (1.4) 
[1] 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)]


  Outcome Measures

1.  Primary:   Triglycerides Levels at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 1

2.  Primary:   High Density Lipoprotein (c-HDL) Levels at Week 12.   [ Time Frame: Week 12 ]
  Show Outcome Measure 2

3.  Primary:   Fasting Glucose Levels at Week 12.   [ Time Frame: Week 12 ]
  Show Outcome Measure 3

4.  Primary:   Systolic Blood Pressure at Week 12.   [ Time Frame: Week 12 ]
  Show Outcome Measure 4

5.  Primary:   First Phase of Insulin Secretion at Week 12.   [ Time Frame: Week 12 ]
  Show Outcome Measure 5

6.  Primary:   Total Insulin Secretion at Week 12.   [ Time Frame: Week 12 ]
  Show Outcome Measure 6

7.  Primary:   Total Insulin Sensitivity at Week 12.   [ Time Frame: Week 12 ]
  Show Outcome Measure 7

8.  Primary:   Waist Circumference at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 8

9.  Primary:   Diastolic Blood Pressure at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 9

10.  Secondary:   Weight at Week 12.   [ Time Frame: Week 12 ]
  Show Outcome Measure 10

11.  Secondary:   Body Mass Index at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 11

12.  Secondary:   Total Cholesterol at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 12

13.  Secondary:   Low Density Lipoproteins (c-LDL) at Week 12   [ Time Frame: Week 12 ]
  Show Outcome Measure 13

14.  Secondary:   Creatinine at Week 12.   [ Time Frame: Baseline. Week 12. ]
  Show Outcome Measure 14

15.  Secondary:   Uric Acid at Week 12.   [ Time Frame: Week 12. ]
  Show Outcome Measure 15


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Manuel González Ortiz
Organization: Institute of Experimental andl Clinical Therapeutics
phone: +52-33-10-58-52-00 ext 34212
e-mail: uiec@prodigy.net.mx


Publications of Results:

Other Publications:


Responsible Party: Manuel González Ortiz, University of Guadalajara
ClinicalTrials.gov Identifier: NCT02114892     History of Changes
Other Study ID Numbers: RESV-MS
First Submitted: April 11, 2014
First Posted: April 15, 2014
Results First Submitted: December 2, 2014
Results First Posted: December 29, 2014
Last Update Posted: December 7, 2016