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Obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors.
Tadalafil is Is a drug inhibiting the enzyme phosphodiesterase-5 (PDE-5), responsible for inactivating the vasodilator nitric oxide. USING paragraph was mainly treat erectile dysfunction, and recently approved for the treatment of pulmonary hypertension , it is innovative because of its longer life means, provides efficacy after 36 hours and the highest selectivity.
The aim of this study is to evaluate the effect of tadalafil on insulin sensitivity and insulin secretion in obese men.
The investigators hypothesis is that the administration of tadalafil improve the insulin sensitivity and insulin secretion in obese men.
A randomized, double-blind, placebo-controlled clinical trial in 18 men aged between 30 and 50 years with obesity (BMI 30-39.9) according to the World Health Organization (WHO) criteria without treatment.
They will be assigned randomly in two groups of 9 patients, each to receive 5 mg of tadalafil or placebo every day at night during 28 days.
There will be evaluated Insulin secretion, both first phase of insulin secretion by Stumvoll Inex as well as Total Insulin Secretion by Area Under the Curve of glucose and insulin and Insulinogenic Index, and Insulin sensitivity by Matsuda index.
Waist circumference, glucose and insulin levels, lipid profile and blood pressure are going to be load will be evaluated before and after intervention in both groups.
Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. Will be considered statistical significance p ≤0.05.
This protocol was approved by a local Ethics Committee and written informed consent will be obtained from all volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil | Experimental | Tadalafil capsules |
|
| Placebo | Placebo Comparator | Calcined magnesia capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil | Drug | Tadalafil capsules: 5 mg, one per day, at night, during 28 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Glucose | Fasting glucose will be evaluated at baseline and Day 28 with enzymatic-colorimetric. | Fasting glucose at Day 28 |
| Postprandial Glucose | Postprandial glucose will be evaluated at baseline and Day 28 after a oral glucose. tolerance test with enzymatic-colorimetric techniques. | Postprandial glucose at Day 28 |
| First Phase of Insulin Secretion | First phase of insulin secretion will be calculated at baseline and Day 28 with Stumvoll Index. 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 | First phase of insulin secretion at Day 28 |
| Total Insulin Secretion | Total insulin secretion will be calculated at baseline and Day 28 with Insulinogenic Index. 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 | Total insulin secretion at Day 28 |
| Insulin Sensitivity | Insulin sensitivity will be calculated at baseline and Day 28 with Matsuda Index. 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | The body weight will be measured at baseline and Day 28 by Electrical bioimpedance. | Body Weight at Day 28 |
| Body Mass Index | The Body Mass Index will be measured at baseline and Day 28 by Quetelet Index Formula. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manuel González-OrtÃz, PhD | University of Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Terapéutica Experimental y ClÃnica | Guadalajara | Jalisco | 44140 | Mexico |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tadalafil | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. |
| FG001 | Placebo | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tadalafil | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. |
| BG001 | Placebo | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Fasting Glucose | Fasting glucose will be evaluated at baseline and Day 28 with enzymatic-colorimetric. | Posted | Mean | Standard Deviation | mmol/L | Fasting glucose at Day 28 |
|
|
Throughout the study, an average of 28 days
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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 | Tadalafil | Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | 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 |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Calcined magnesia capsules: one per day, at night, during 28 days. |
|
|
| Insulin sensitivity at Day 28 |
| Area Under the Curve (AUC) Glucose | Area under the curve of glucose measured at baseline and Day 28. The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. | AUC at Day 28 |
| Area Under the Curve (AUC) Insulin | Area under the curve of insulin measured at baseline and Day 28. The Area Under the Curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. | AUC at Day 28 |
| Body Mass Index at Day 28 |
| Waist Circumference | Waist circumference was evaluated at baseline and at Day 28 with a flexible tape. | Waist circumference at Day 28 |
| Triglycerides | Triglycerides levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. | Triglycerides levels at Day 28 |
| Total Cholesterol | Total cholesterol levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. | Total cholesterol levels at Day 28 |
| High Density Lipoprotein Cholesterol (HDL-c) | High density lipoprotein cholesterol (HDL-c) levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. | HDL-c levels at Day 28 |
| Low Density Lipoprotein Cholesterol (LDL-c) | Low density lipoprotein cholesterol (LDL-c) levels will be evaluated at baseline and Day 28 with Friedewald formula. | LDL-c levels at Day 28 |
| Systolic Blood Pressure | The systolic blood pressure was evaluated at baseline and Day 28 with a digital sphygmomanometer. | Systolic Blood Pressure at Day 28 |
| Diastolic Blood Pressure | Diastolic Blood Pressure at Day 28 |
| Body Fat | The body fat will be measured at baseline and Day 28 by Electrical bioimpedance in % | Body fat at Day 28 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fasting Glucose | Mean | Standard Deviation | mmol/L |
|
| Postprandial Glucose | Mean | Standard Deviation | mmol/L |
|
| First Phase of Insulin | 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 |
|
| 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 |
|
| 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 |
|
| Body Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| Total Cholesterol | Mean | Standard Deviation | mmol/L |
|
| High Density LIpoprotein cholesterol (HDL-c) | Mean | Standard Deviation | mmol/L |
|
| Low density lipoprotein cholesterol (LDL-c) | Mean | Standard Deviation | mmol/L |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Body Fat | Mean | Standard Deviation | % |
|
| Area under the curve (AUC) glucose | The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. | Mean | Standard Deviation | mmol*h/L |
|
| Area under the curve (AUC) insulin | The area under the curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. | Mean | Standard Deviation | pmol*h/L |
|
| Participants |
|
|
|
| Primary | Postprandial Glucose | Postprandial glucose will be evaluated at baseline and Day 28 after a oral glucose. tolerance test with enzymatic-colorimetric techniques. | Posted | Mean | Standard Deviation | mmol/L | Postprandial glucose at Day 28 |
|
|
|
|
| Primary | First Phase of Insulin Secretion | First phase of insulin secretion will be calculated at baseline and Day 28 with Stumvoll Index. 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 | Posted | Mean | Standard Deviation | index | First phase of insulin secretion at Day 28 |
|
|
|
|
| Primary | Total Insulin Secretion | Total insulin secretion will be calculated at baseline and Day 28 with Insulinogenic Index. 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 | Posted | Mean | Standard Deviation | index | Total insulin secretion at Day 28 |
|
|
|
|
| Primary | Insulin Sensitivity | Insulin sensitivity will be calculated at baseline and Day 28 with Matsuda Index. 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 | Posted | Mean | Standard Deviation | index | Insulin sensitivity at Day 28 |
|
|
|
|
| Primary | Area Under the Curve (AUC) Glucose | Area under the curve of glucose measured at baseline and Day 28. The area under the curve (AUC) of glucose, (0.5 * glucose (G) 0´ + (G 30´+G 60´ + G 90´) + 0.5 * G 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperglycemia. | Posted | Mean | Standard Deviation | mmol*h/L | AUC at Day 28 |
|
|
|
|
| Primary | Area Under the Curve (AUC) Insulin | Area under the curve of insulin measured at baseline and Day 28. The Area Under the Curve (AUC) of insulin, (0.5 * Insulin (I) 0´ + (I 30´+I 60´ + I 90´) + 0.5 * I 120´) * 30; has been widely used for calculating the glycemic index and for evaluating the efficacy of medications for postprandial hyperinsulinemia. | Posted | Mean | Standard Deviation | pmol*h/L | AUC at Day 28 |
|
|
|
|
| Secondary | Body Weight | The body weight will be measured at baseline and Day 28 by Electrical bioimpedance. | Posted | Mean | Standard Deviation | kg | Body Weight at Day 28 |
|
|
|
|
| Secondary | Body Mass Index | The Body Mass Index will be measured at baseline and Day 28 by Quetelet Index Formula. | Posted | Mean | Standard Deviation | kg/m^2 | Body Mass Index at Day 28 |
|
|
|
|
| Secondary | Waist Circumference | Waist circumference was evaluated at baseline and at Day 28 with a flexible tape. | Posted | Mean | Standard Deviation | cm | Waist circumference at Day 28 |
|
|
|
|
| Secondary | Triglycerides | Triglycerides levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. | Posted | Mean | Standard Deviation | mmol/L | Triglycerides levels at Day 28 |
|
|
|
|
| Secondary | Total Cholesterol | Total cholesterol levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. | Posted | Mean | Standard Deviation | mmol/L | Total cholesterol levels at Day 28 |
|
|
|
|
| Secondary | High Density Lipoprotein Cholesterol (HDL-c) | High density lipoprotein cholesterol (HDL-c) levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques. | Posted | Mean | Standard Deviation | mmol/L | HDL-c levels at Day 28 |
|
|
|
|
| Secondary | Low Density Lipoprotein Cholesterol (LDL-c) | Low density lipoprotein cholesterol (LDL-c) levels will be evaluated at baseline and Day 28 with Friedewald formula. | Posted | Mean | Standard Deviation | mmol/L | LDL-c levels at Day 28 |
|
|
|
|
| Secondary | Systolic Blood Pressure | The systolic blood pressure was evaluated at baseline and Day 28 with a digital sphygmomanometer. | Posted | Mean | Standard Deviation | mmHg | Systolic Blood Pressure at Day 28 |
|
|
|
|
| Secondary | Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Diastolic Blood Pressure at Day 28 |
|
|
|
|
| Secondary | Body Fat | The body fat will be measured at baseline and Day 28 by Electrical bioimpedance in % | Posted | Mean | Standard Deviation | percentage of fat | Body fat at Day 28 |
|
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 3 |
| 9 |
| EG001 | Placebo | Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days. | 0 | 9 | 0 | 9 | 4 | 9 |
| Chills | Infections and infestations | Systematic Assessment |
|
| Muscle pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Edema | Renal and urinary disorders | Systematic Assessment |
|
| Insomnia | Nervous system disorders | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
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