ObesityPhase 4NCT02595684

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

A Phase 4 study testing Tadalafil in people with Obesity, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 30 to 50 years, men only
Conditions the study is for: Obesity
What is being tested?: Tadalafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 1 siteMexico
Study dates: Aug 2015to Nov 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 50 years
Men only
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

Cholesterol: ≥ 240 mg / dl
Triglycerides: ≥ 400 mg / dl
Fasting glucose: ≥ 126 mg / dl
Diabetes mellitus.
Hypertension
Patients with renal, liver and / or thyroid disease

Show all 9Show fewer

Consumption of drugs with known effects on glucose or insulin metabolism.
Use of cigar and / or drugs
Hypersensitivity to tadalafil

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto de Terapéutica Experimental y Clínica
Guadalajara, Jalisco, 44140

Other trials in Mexico

About this study

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.

Read the detailed description

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.

Conditions: Obesity
Being tested: Tadalafil, Placebo
Keywords: Obesity, Tadalfil, Insulin secretion, Insulin sensitivity
Medical subject headings: Obesity, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TadalafilDrug
Also called Tadalafilo
Tadalafil capsules: 5 mg, one per day, at night, during 28 days.
PlaceboDrug
Also called Calcined magnesia
Calcined magnesia capsules: one per day, at night, during 28 days.

Study groups in NCT02595684
Study group	Role	What they receive
Tadalafil	Experimental	Tadalafil capsules Receives: Drug: Tadalafil
Placebo	Placebo comparator	Calcined magnesia capsules Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Glucose
Fasting glucose will be evaluated at baseline and Day 28 with enzymatic-colorimetric.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: AUC at Day 28

Secondary outcomes (10)

Body Weight
The body weight will be measured at baseline and Day 28 by Electrical bioimpedance.
Measured: Body Weight at Day 28
Body Mass Index
The Body Mass Index will be measured at baseline and Day 28 by Quetelet Index Formula.
Measured: Body Mass Index at Day 28
Waist Circumference
Waist circumference was evaluated at baseline and at Day 28 with a flexible tape.
Measured: Waist circumference at Day 28
Triglycerides
Triglycerides levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.
Measured: Triglycerides levels at Day 28
Total Cholesterol
Total cholesterol levels will be evaluated at baseline and Day 28 with enzymatic-colorimetric techniques.
Measured: 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.
Measured: 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.
Measured: LDL-c levels at Day 28
Systolic Blood Pressure
The systolic blood pressure was evaluated at baseline and Day 28 with a digital sphygmomanometer.
Measured: Systolic Blood Pressure at Day 28
Diastolic Blood Pressure
Measured: Diastolic Blood Pressure at Day 28
Body Fat
The body fat will be measured at baseline and Day 28 by Electrical bioimpedance in %
Measured: Body fat at Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2015Nov 2015

First posted3 Nov 2015 (estimated)
Study startAug 2015
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02595684
Sponsor's protocol ID: TADALAFIL-OB
Status last verified: Sep 2020
First submitted: 9 Sep 2015
Last updated: 9 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men.
ClinicalTrials.gov ID: NCT02595684
Acronym / sponsor ID: TADALAFIL-OB
Conditions: Obesity
Keywords: Obesity, Tadalfil, Insulin secretion, Insulin sensitivity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Aug 2015 (actual)
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 3 Nov 2015 (estimated)
Results: Posted 9 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Obesity is a chronic disease of multifactorial etiology that develops from the interaction of the influence of nutritive , metabolic , cellular and molecular psychological factors.

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.

Detailed description

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.

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.

This protocol was approved by a local Ethics Committee and written informed consent will be obtained from all volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Tadalafil	Experimental	Drug: TadalafilTadalafil capsules
Placebo	Placebo comparator	Drug: PlaceboCalcined magnesia capsules

Who may qualify

Ages: 30 to 50 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (9 listed)

Cholesterol: ≥ 240 mg / dl
Triglycerides: ≥ 400 mg / dl
Fasting glucose: ≥ 126 mg / dl
Diabetes mellitus.
Hypertension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TadalafilAlso: TadalafiloTadalafil capsules: 5 mg, one per day, at night, during 28 days.	Drug	Tadalafil
PlaceboAlso: Calcined magnesiaCalcined magnesia capsules: one per day, at night, during 28 days.	Drug	Placebo

Primary outcome

Fasting Glucose
Time frame: Fasting glucose at Day 28
Fasting glucose will be evaluated at baseline and Day 28 with enzymatic-colorimetric.
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.
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
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
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
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.
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.

10 secondary outcomes

Body Weight
Time frame: Body Weight at Day 28
Body Mass Index
Time frame: Body Mass Index at Day 28
Waist Circumference
Time frame: Waist circumference at Day 28
Triglycerides
Time frame: Triglycerides levels at Day 28
Total Cholesterol
Time frame: Total cholesterol levels at Day 28
High Density Lipoprotein Cholesterol (HDL-c)
Time frame: HDL-c levels at Day 28
Low Density Lipoprotein Cholesterol (LDL-c)
Time frame: LDL-c levels at Day 28
Systolic Blood Pressure
Time frame: Systolic Blood Pressure at Day 28
Diastolic Blood Pressure
Time frame: Diastolic Blood Pressure at Day 28
Body Fat
Time frame: Body fat at Day 28

Results and safety

Results posted to the registry on 9 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tadalafil	9	9
Placebo	9	9

Primary outcome: Fasting Glucose

Time frame: Fasting glucose at Day 28. Mean (Standard Deviation). Unit: mmol/L

Measure	Tadalafil n = 9	Placebo n = 9
Value	4.8 (0.6)	5.0 (0.5)

Placebo: p = 0.327, Wilcoxon (Mann-Whitney)
Tadalafil: p = 0.635, Wilcoxon (Mann-Whitney)

Primary outcome: Postprandial Glucose

Time frame: Postprandial glucose at Day 28. Mean (Standard Deviation). Unit: mmol/L

Measure	Tadalafil n = 9	Placebo n = 9
Value	6.3 (2.1)	6.5 (2.3)

Placebo: p = 0.380, Wilcoxon (Mann-Whitney)
Tadalafil: p = 0.441, Wilcoxon (Mann-Whitney)

Primary outcome: First Phase of Insulin Secretion

Time frame: First phase of insulin secretion at Day 28. Mean (Standard Deviation). Unit: index

Measure	Tadalafil n = 9	Placebo n = 9
Value	1602 (800)	1194 (490)

Placebo: p = 0515, Wilcoxon (Mann-Whitney)
Tadalafil: p = 0.953, Wilcoxon (Mann-Whitney)

Primary outcome: Total Insulin Secretion

Time frame: Total insulin secretion at Day 28. Mean (Standard Deviation). Unit: index

Measure	Tadalafil n = 9	Placebo n = 9
Value	0.52 (0.29)	0.61 (0.27)

Placebo: p = 0.314, Wilcoxon (Mann-Whitney)
Tadalafil: p = 0.594, Wilcoxon (Mann-Whitney)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study, an average of 28 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tadalafil	0 of 9 (0%)	3 of 9 (33.3%)	0 of 9
Placebo	0 of 9 (0%)	4 of 9 (44.4%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Obesity

RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Manuel González-Ortíz, PhD principal investigator

University of Guadalajara

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tadalafil in people with Obesity, run by University of Guadalajara at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Glucose (time frame: Fasting glucose at Day 28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02595684.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2020.