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

NCT02595684 | Completed Phase 4 Results

• 1 other identifier: TADALAFIL-OB
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Obesity; Tadalfil; Insulin secretion; Insulin sensitivity

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (10)

• Body Weight

  Body Weight at Day 28

• Body Mass Index

  Body Mass Index at Day 28

• Waist Circumference

  Waist circumference at Day 28

• Triglycerides

  Triglycerides levels at Day 28

• Total Cholesterol

  Total cholesterol levels at Day 28

Study Arms (2)

Tadalafil

EXPERIMENTAL

Tadalafil capsules

Drug: Tadalafil

Placebo

PLACEBO COMPARATOR

Calcined magnesia capsules

Drug: Placebo

Interventions

Tadalafil DRUG

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

Also known as: Tadalafilo

Tadalafil

Placebo DRUG

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

Also known as: Calcined magnesia

Placebo

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead

Study Sites (1)

Instituto de Terapéutica Experimental y Clínica

Guadalajara, Jalisco, 44140, Mexico

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: DR. MANUEL GONZALEZ ORTIZ
• Organization: INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA

uiec@prodigy.net.mx

+52 3310585200

Study Officials

• Manuel González-Ortíz, PhD

  University of Guadalajara

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: November 3, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Locations

ME (1)