Phase 4
Completed N=18
Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
Source: ClinicalTrials.gov NCT02595684 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Fasting Glucose — 4.8; 5.0 mmol/L — p=0.327
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fasting Glucose |
4.8; 5.0 | 0.327 |
| PRIMARY Postprandial Glucose |
6.3; 6.5 | 0.380 |
| PRIMARY First Phase of Insulin Secretion |
1602; 1194 | 0515 |
| PRIMARY Total Insulin Secretion |
0.52; 0.61 | 0.314 |
| PRIMARY Insulin Sensitivity |
4.8; 4.9 | 0.767 |
| PRIMARY Area Under the Curve (AUC) Glucose |
503; 522 | 0.859 |
| PRIMARY Area Under the Curve (AUC) Insulin |
291; 262 | 0.374 |
| SECONDARY Body Weight |
99.1; 98.2 | 0.594 |
| SECONDARY Body Mass Index |
33.7; 33.1 | 0.594 |
| SECONDARY Waist Circumference |
112; 112 | 0.285 |
| SECONDARY Triglycerides |
2.3; 2.4 | 0.374 |
| SECONDARY Total Cholesterol |
4.4; 4.3 | 0.859 |
| SECONDARY High Density Lipoprotein Cholesterol (HDL-c) |
1.1; 1.1 | 0.722 |
| SECONDARY Low Density Lipoprotein Cholesterol (LDL-c) |
2.3; 2.2 | 0.260 |
| SECONDARY Systolic Blood Pressure |
120; 115 | 0.058 |
| SECONDARY Diastolic Blood Pressure |
77; 73 | 0.128 |
| SECONDARY Body Fat |
33.7; 33.1 | 0.092 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02595684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.