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Completed

NCT Number: NCT02595684

Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.

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.

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Key information

Conditions

Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, 44140, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men
  • Age: 30-50 years
  • BMI: 30 to 39.9 kg/m²
  • No Pharmacotherapy during the last 3 months
  • Signature Consent under Information

Exclusion criteria

  • Cholesterol: ≥ 240 mg / dl
  • Triglycerides: ≥ 400 mg / dl
  • Fasting glucose: ≥ 126 mg / dl
  • Diabetes mellitus.
  • Hypertension
  • Patients with renal, liver and / or thyroid disease
  • Consumption of drugs with known effects on glucose or insulin metabolism.
  • Use of cigar and / or drugs
  • Hypersensitivity to tadalafil

Treatment and study plan

Tadalafil

Drug

Tadalafil capsules: 5 mg, one per day, at night, during 28 days.

Other names: Tadalafilo

Placebo

Drug

Calcined magnesia capsules: one per day, at night, during 28 days.

Other names: Calcined magnesia

Primary outcomes

  1. Fasting Glucose

    Time frame: Fasting glucose at Day 28

    Fasting glucose will be evaluated at baseline and Day 28 with enzymatic-colorimetric.

  2. Postprandial Glucose

    Time frame: Postprandial glucose at Day 28

    Postprandial glucose will be evaluated at baseline and Day 28 after a oral glucose. tolerance test with enzymatic-colorimetric techniques.

  3. First Phase of Insulin Secretion

    Time frame: First phase of insulin secretion at Day 28

    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

  4. Total Insulin Secretion

    Time frame: Total insulin secretion at Day 28

    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

  5. Insulin Sensitivity

    Time frame: Insulin sensitivity at Day 28

    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

  6. Area Under the Curve (AUC) Glucose

    Time frame: AUC at Day 28

    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.

  7. Area Under the Curve (AUC) Insulin

    Time frame: AUC at Day 28

    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.

Secondary outcomes

  1. Body Weight

    Time frame: Body Weight at Day 28

    The body weight will be measured at baseline and Day 28 by Electrical bioimpedance.

  2. Body Mass Index

    Time frame: Body Mass Index at Day 28

    The Body Mass Index will be measured at baseline and Day 28 by Quetelet Index Formula.

  3. Waist Circumference

    Time frame: Waist circumference at Day 28

    Waist circumference was evaluated at baseline and at Day 28 with a flexible tape.

  4. Triglycerides

    Time frame: Triglycerides levels at Day 28

    Triglycerides levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.

  5. Total Cholesterol

    Time frame: Total cholesterol levels at Day 28

    Total cholesterol levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.

  6. High Density Lipoprotein Cholesterol (HDL-c)

    Time frame: HDL-c levels at Day 28

    High density lipoprotein cholesterol (HDL-c) levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.

  7. Low Density Lipoprotein Cholesterol (LDL-c)

    Time frame: LDL-c levels at Day 28

    Low density lipoprotein cholesterol (LDL-c) levels will be evaluated at baseline and Day 28 with Friedewald formula.

  8. Systolic Blood Pressure

    Time frame: Systolic Blood Pressure at Day 28

    The systolic blood pressure was evaluated at baseline and Day 28 with a digital sphygmomanometer.

  9. Diastolic Blood Pressure

    Time frame: Diastolic Blood Pressure at Day 28

  10. Body Fat

    Time frame: Body fat at Day 28

    The body fat will be measured at baseline and Day 28 by Electrical bioimpedance in %

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 3, 2015
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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