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The Metabolic Syndrome is a high prevalence disease worldwide. About a quarter of the adult population suffers the disease.
Dapagliflozin is an inhibitor of the sodium-glucose co-transporter SGLT2 in the kidney and is a novel treatment for diabetes type 2. Some studies indicate that SGLT2 inhibitors have benefits on blood pressure, triglycerides levels and help to raise the levels of high density lipoproteins cholesterol (c-HDL).
The aim of this study is to evaluate the effect of dapagliflozin on metabolic syndrome, insulin sensitivity and insulin secretion.
The investigators hypothesis is that the administration of dapagliflozin modifies the metabolic syndrome, insulin sensitivity and insulin secretion.
A randomized, double-blind, placebo-controlled clinical trial its going to carry out in 24 patients with a diagnosis of metabolic syndrome in accordance with the International Diabetes Federation (IDF). Waist circumference, glucose, insulin levels, lipid profile, creatinine and acid uric are going to be load after a 75 g of dextrose load.
12 patients will receive Forxiga (dapagliflozin), 10 mg, one per day before breakfast during 3 months.
The remaining 12 patients will receive placebo at the same dose.
There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).
This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.
Results will be presented as mean and standard deviation. Intra and inter group differences are going to be tested using the Wilcoxon signed-rank and Mann-Whitney U-test respectively; p≤0.05 it's going to be considered significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. |
|
| Placebo | Placebo Comparator | Placebo capsules, 10 mg, one per day before breakfast during 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference at Week 12. | The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques. | Week 12 |
| Triglycerides Levels at Week 12. | The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques. | Week 12 |
| High Density Lipoprotein (c-HDL) Levels at Week 12. | The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. | Week 12 |
| Glucose Levels at Minute 0 at Week 12. | The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. | Week 12 |
| Systolic Blood Pressure at Week 12. | The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. | Week 12 |
| Diastolic Blood Pressure at Week 12. | The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. | Week 12 |
| Insulinogenic Index (Total Insulin Secretion) at Week 12. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight at Week 12. | The weight it's going to be measured at week 12 with a bioimpedance balance. | Week 12 |
| Body Mass Index at Week 12 | The Body Mass index it's going to be calculated at week 12 with the Quetelet index. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MANUEL GONZALEZ, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Terapeútica Experimental y ClÃnica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara | Guadalajara | Jalisco | 44340 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22238392 | Background | Bolinder J, Ljunggren O, Kullberg J, Johansson L, Wilding J, Langkilde AM, Sugg J, Parikh S. Effects of dapagliflozin on body weight, total fat mass, and regional adipose tissue distribution in patients with type 2 diabetes mellitus with inadequate glycemic control on metformin. J Clin Endocrinol Metab. 2012 Mar;97(3):1020-31. doi: 10.1210/jc.2011-2260. Epub 2012 Jan 11. | |
| 22446170 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin | Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. |
| FG001 | Placebo | Placebo capsules, 10 mg, one per day before breakfast during 90 days. Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin | Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Waist Circumference at Week 12. | The waist circumference is going to be evaluated at week 12 with a flexible tape with standardized techniques. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | centimeters | Week 12 |
|
Adverse events were collected during the 12 weeks of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapagliflozin | Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. Dapagliflozin: Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DR. MANUEL GONZALEZ ORTIZ | INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA | +52 3310585200 | 34212 | uiec@prodigy.net.mx |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo | Drug | Placebo capsules, 10 mg, one per day before breakfast during 90 days. |
|
|
| Week 12 |
| Stumvoll Index (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. | Week 12 |
| Matsuda Index (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. | Week 12 |
| Week 12 |
| Fat Mass at Week 12. | The fat mass is going to be evaluated at week 12 through bioimpedance. | Week 12 |
| Total Cholesterol at Week 12 | The total cholesterol will be estimated by standardized techniques at week 12. | Week 12 |
| Low Density Lipoproteins (c-LDL) at Week 12 | The c-LDL levels are going to be measured at week 12 with standardized techniques. | Week 12 |
| Alanine Aminotransferase (ALT) at Week 12. | The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques. | Week 12. |
| Aspartate Aminotransferase (AST) at Week 12. | The hepatic transaminase AST will be evaluated with standardized methods at week 12 | Week 12 |
| Creatinine at Week 12. | The creatinine levels are going to be measured at week 12 with standardized techniques. | Week 12. |
| Uric Acid at Week 12. | The uric acid levels are going to be measured at week 12 with standardized techniques. | Week 12. |
| AUC of Glucose at Week 12. | The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12 | Week 12 |
| AUC of Insulin at Week 12. | The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12 | Week 12 |
| Glucose at Minute 30 at Week 12. | The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Week 12 |
| Glucose at Minute 60 at Week 12. | The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Week 12 |
| Glucose at Minute 90 at Week 12. | The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Week 12 |
| Glucose at Minute 120 at Week 12. | The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Week 12 |
| Background |
| Rosenstock J, Vico M, Wei L, Salsali A, List JF. Effects of dapagliflozin, an SGLT2 inhibitor, on HbA(1c), body weight, and hypoglycemia risk in patients with type 2 diabetes inadequately controlled on pioglitazone monotherapy. Diabetes Care. 2012 Jul;35(7):1473-8. doi: 10.2337/dc11-1693. Epub 2012 Mar 23. |
| 22701099 | Background | Chao EC. Dapagliflozin: an evidence-based review of its potential in the treatment of type-2 diabetes. Core Evid. 2012;7:21-8. doi: 10.2147/CE.S16359. Epub 2012 Jun 1. |
| 24105299 | Background | Kasichayanula S, Liu X, Lacreta F, Griffen SC, Boulton DW. Clinical pharmacokinetics and pharmacodynamics of dapagliflozin, a selective inhibitor of sodium-glucose co-transporter type 2. Clin Pharmacokinet. 2014 Jan;53(1):17-27. doi: 10.1007/s40262-013-0104-3. |
| 23910664 | Background | Yang L, Li H, Li H, Bui A, Chang M, Liu X, Kasichayanula S, Griffen SC, Lacreta FP, Boulton DW. Pharmacokinetic and pharmacodynamic properties of single- and multiple-dose of dapagliflozin, a selective inhibitor of SGLT2, in healthy Chinese subjects. Clin Ther. 2013 Aug;35(8):1211-1222.e2. doi: 10.1016/j.clinthera.2013.06.017. Epub 2013 Aug 2. |
| 19996149 | Background | Obermeier M, Yao M, Khanna A, Koplowitz B, Zhu M, Li W, Komoroski B, Kasichayanula S, Discenza L, Washburn W, Meng W, Ellsworth BA, Whaley JM, Humphreys WG. In vitro characterization and pharmacokinetics of dapagliflozin (BMS-512148), a potent sodium-glucose cotransporter type II inhibitor, in animals and humans. Drug Metab Dispos. 2010 Mar;38(3):405-14. doi: 10.1124/dmd.109.029165. Epub 2009 Dec 8. |
| 23210765 | Background | Kasichayanula S, Liu X, Pe Benito M, Yao M, Pfister M, LaCreta FP, Humphreys WG, Boulton DW. The influence of kidney function on dapagliflozin exposure, metabolism and pharmacodynamics in healthy subjects and in patients with type 2 diabetes mellitus. Br J Clin Pharmacol. 2013 Sep;76(3):432-44. doi: 10.1111/bcp.12056. |
| 24130972 | Background | Kilov G, Leow S, Thomas M. SGLT2 inhibition with dapagliflozin -- a novel approach for the management of type 2 diabetes. Aust Fam Physician. 2013 Oct;42(10):706-10. |
| 23194084 | Background | Kaku K, Inoue S, Matsuoka O, Kiyosue A, Azuma H, Hayashi N, Tokudome T, Langkilde AM, Parikh S. Efficacy and safety of dapagliflozin as a monotherapy for type 2 diabetes mellitus in Japanese patients with inadequate glycaemic control: a phase II multicentre, randomized, double-blind, placebo-controlled trial. Diabetes Obes Metab. 2013 May;15(5):432-40. doi: 10.1111/dom.12047. Epub 2013 Jan 25. |
| 20518806 | Background | Zhang L, Feng Y, List J, Kasichayanula S, Pfister M. Dapagliflozin treatment in patients with different stages of type 2 diabetes mellitus: effects on glycaemic control and body weight. Diabetes Obes Metab. 2010 Jun;12(6):510-6. doi: 10.1111/j.1463-1326.2010.01216.x. |
| 23668478 | Background | Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab. 2013 Sep;15(9):853-62. doi: 10.1111/dom.12127. Epub 2013 Jun 5. |
| 20566676 | Background | Ferrannini E, Ramos SJ, Salsali A, Tang W, List JF. Dapagliflozin monotherapy in type 2 diabetic patients with inadequate glycemic control by diet and exercise: a randomized, double-blind, placebo-controlled, phase 3 trial. Diabetes Care. 2010 Oct;33(10):2217-24. doi: 10.2337/dc10-0612. Epub 2010 Jun 21. |
| 23906445 | Background | Bolinder J, Ljunggren O, Johansson L, Wilding J, Langkilde AM, Sjostrom CD, Sugg J, Parikh S. Dapagliflozin maintains glycaemic control while reducing weight and body fat mass over 2 years in patients with type 2 diabetes mellitus inadequately controlled on metformin. Diabetes Obes Metab. 2014 Feb;16(2):159-69. doi: 10.1111/dom.12189. Epub 2013 Aug 29. |
| 24463448 | Background | Merovci A, Solis-Herrera C, Daniele G, Eldor R, Fiorentino TV, Tripathy D, Xiong J, Perez Z, Norton L, Abdul-Ghani MA, DeFronzo RA. Dapagliflozin improves muscle insulin sensitivity but enhances endogenous glucose production. J Clin Invest. 2014 Feb;124(2):509-14. doi: 10.1172/JCI70704. Epub 2014 Jan 27. |
Placebo capsules, 10 mg, one per day before breakfast during 90 days.
Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight (kg) | Mean | Standard Deviation | kilograms |
|
| Body Mass Index (BMI) (kg/m^2) | Mean | Standard Deviation | kg/m^2 |
|
| Fat mass (kg) | Mean | Standard Deviation | kilograms |
|
| Waist circumference (WC) (cm) | Mean | Standard Deviation | centimeters |
|
| Systolic Blood Pressure (SBP) (mmHg) | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure (DBP) (mmHg) | Mean | Standard Deviation | mmHg |
|
| Glucose at minute 0 (0') (mmol/L) | 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 (minute 0') and at the minutes 30 (30'), 60 (60'), 90 (90') and 120 (120') after a 75 g oral dextrose load. | Mean | Standard Deviation | mmol/L |
|
| Glucose at minute 30 (30') (mmol/L) | 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 (minute 0') and at the minutes 30 (30'), 60 (60'), 90 (90') and 120 (120') after a 75 g oral dextrose load. | Mean | Standard Deviation | mmol/L |
|
| Glucose at minute 60 (60') (mmol/L) | 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 (minute 0') and at the minutes 30 (30'), 60 (60'), 90 (90') and 120 (120') after a 75 g oral dextrose load. | Mean | Standard Deviation | mmol/L |
|
| Glucose at minute 90 (90') (mmol/L) | 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 (minute 0') and at the minutes 30 (30'), 60 (60'), 90 (90') and 120 (120') after a 75 g oral dextrose load. | Mean | Standard Deviation | mmol/L |
|
| Glucose at minute 120 (120') (mmol/L) | 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 (minute 0') and at the minutes 30 (30'), 60 (60'), 90 (90') and 120 (120') after a 75 g oral dextrose load. | Mean | Standard Deviation | mmol/L |
|
| Total cholesterol (mmol/L) | Mean | Standard Deviation | mmol/L |
|
| Triglycerides (mmol/L) | Mean | Standard Deviation | mmol/L |
|
| HDL-cholesterol (mmol/L) | Mean | Standard Deviation | mmol/L |
|
| LDL-cholesterol (mmol/L) | Mean | Standard Deviation | mmol/L |
|
| Area Under the Curve (AUC) glucose (mmol*hr/L) | Mean | Standard Deviation | mmol*hr/L |
|
| Area Under the Curve (AUC) insulin (pmol*hr/L) | Mean | Standard Deviation | pmol*hr/L |
|
| Insulinogenic index (total insulin secretion) | 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 | Mean | Standard Deviation | index |
|
| Stumvoll Index (first phase of insulin secretion) | 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 first phase of insulin secretion | Mean | Standard Deviation | index |
|
| Matsuda Index (insulin sensitivity) | 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 | Mean | Standard Deviation | index |
|
| Creatinine (mmol/L) | Mean | Standard Deviation | mmol/L |
|
| Uric acid (umol/L) | Mean | Standard Deviation | umol/L |
|
| Alanine aminotransferase (ALT) | Mean | Standard Deviation | U/L |
|
| Aspartate aminotransferase (AST) | Mean | Standard Deviation | U/L |
|
|
|
|
| Primary | Triglycerides Levels at Week 12. | The triglycerides levels are going to be evaluated at week 12 with enzymatic-colorimetric techniques. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | High Density Lipoprotein (c-HDL) Levels at Week 12. | The c-HDL levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Glucose Levels at Minute 0 at Week 12. | The fasting glucose (0') levels are going to be evaluated at week 12 with enzymatic/colorimetric techniques. | All participants, including those who dropped out before the end were taken into account for statistical analysis (intention to treat) | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Primary | Systolic Blood Pressure at Week 12. | The systolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Primary | Diastolic Blood Pressure at Week 12. | The diastolic blood pressure is going to be evaluated at week 12 with a digital sphygmomanometer. | Posted | Mean | Standard Deviation | mmHg | Week 12 |
|
|
|
|
| Primary | Insulinogenic Index (Total Insulin Secretion) at Week 12. | 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. | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Primary | Stumvoll Index (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. | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Primary | Matsuda Index (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. | Posted | Mean | Standard Deviation | index | Week 12 |
|
|
|
|
| Secondary | Body Weight at Week 12. | The weight it's going to be measured at week 12 with a bioimpedance balance. | Posted | Mean | Standard Deviation | kilograms | Week 12 |
|
|
|
|
| Secondary | Body Mass Index at Week 12 | The Body Mass index it's going to be calculated at week 12 with the Quetelet index. | Posted | Mean | Standard Deviation | kg/m^2 | Week 12 |
|
|
|
|
| Secondary | Fat Mass at Week 12. | The fat mass is going to be evaluated at week 12 through bioimpedance. | Posted | Mean | Standard Deviation | kilograms | Week 12 |
|
|
|
|
| Secondary | Total Cholesterol at Week 12 | The total cholesterol will be estimated by standardized techniques at week 12. | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Low Density Lipoproteins (c-LDL) at Week 12 | The c-LDL levels are going to be measured at week 12 with standardized techniques. | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Alanine Aminotransferase (ALT) at Week 12. | The ALT hepatic transaminase levels are going to be measured at week 12 with standardized techniques. | Posted | Mean | Standard Deviation | U/L | Week 12. |
|
|
|
|
| Secondary | Aspartate Aminotransferase (AST) at Week 12. | The hepatic transaminase AST will be evaluated with standardized methods at week 12 | Posted | Mean | Standard Deviation | U/L | Week 12 |
|
|
|
|
| Secondary | Creatinine at Week 12. | The creatinine levels are going to be measured at week 12 with standardized techniques. | Posted | Mean | Standard Deviation | mmol/L | Week 12. |
|
|
|
|
| Secondary | Uric Acid at Week 12. | The uric acid levels are going to be measured at week 12 with standardized techniques. | Posted | Mean | Standard Deviation | umol/L | Week 12. |
|
|
|
|
| Secondary | AUC of Glucose at Week 12. | The AUC of glucose will be calculated from the glucose values obtained from the minuted oral glucose tolerance curve at week 12 | Posted | Mean | Standard Deviation | mmol*hr/L | Week 12 |
|
|
|
|
| Secondary | AUC of Insulin at Week 12. | The AUC will be calculated from the insulin values obtained from the minuted oral glucose tolerance curve at week 12 | Posted | Mean | Standard Deviation | pmol*h/L | Week 12 |
|
|
|
|
| Secondary | Glucose at Minute 30 at Week 12. | The glucose at minute 30 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Glucose at Minute 60 at Week 12. | The glucose at minute 60 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Glucose at Minute 90 at Week 12. | The glucose at minute 90 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| Secondary | Glucose at Minute 120 at Week 12. | The glucose at minute 120 is going to be evaluated at week 12 during a minuted oral glucose tolerance curve | Posted | Mean | Standard Deviation | mmol/L | Week 12 |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Placebo | Placebo capsules, 10 mg, one per day before breakfast during 90 days. Placebo: Placebo capsules, 10 mg, one per day before breakfast during 90 days. | 0 | 12 | 0 | 12 | 0 | 12 |
Not provided
Not provided
Not provided
| Wilcoxon (Mann-Whitney) |
| 0.248 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.079 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.918 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.454 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| 0.407 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.826 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.413 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.432 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.835 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.778 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.309 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.563 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.206 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.950 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.454 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.055 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.787 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.365 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.175 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.123 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.268 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.462 |
The threshold for statistical significance was p=0.05 |
| Superiority |
| Wilcoxon (Mann-Whitney) |
| 0.002 |
The threshold for statistical significance was p=0.05 |
| Superiority |