Trial Outcomes & Findings for Effect of Tadalafil on Insulin Secretion and Insulin Sensitivity in Obese Men. (NCT NCT02595684)

NCT ID: NCT02595684

Last Updated: 2020-10-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 18 participants
• Primary outcome timeframe: Fasting glucose at Day 28
• Results posted on: 2020-10-09

Participant Flow

Participant milestones

Measure	Tadalafil Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Overall Study STARTED	9	9
Overall Study COMPLETED	9	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	40.2 years STANDARD_DEVIATION 7.9 • n=5 Participants	38.4 years STANDARD_DEVIATION 6.4 • n=7 Participants	39.3 years STANDARD_DEVIATION 7.2 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Region of Enrollment Mexico	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants
Fasting Glucose	4.9 mmol/L STANDARD_DEVIATION 0.4 • n=5 Participants	4.8 mmol/L STANDARD_DEVIATION 0.7 • n=7 Participants	4.85 mmol/L STANDARD_DEVIATION 0.55 • n=5 Participants
Postprandial Glucose	6.6 mmol/L STANDARD_DEVIATION 1.9 • n=5 Participants	5.4 mmol/L STANDARD_DEVIATION 1.3 • n=7 Participants	6 mmol/L STANDARD_DEVIATION 1.6 • n=5 Participants
First Phase of Insulin	1332 index STANDARD_DEVIATION 487 • n=5 Participants	1135 index STANDARD_DEVIATION 598 • n=7 Participants	1233.5 index STANDARD_DEVIATION 542.5 • n=5 Participants
Total Insulin Secretion	0.82 index STANDARD_DEVIATION 0.45 • n=5 Participants	0.45 index STANDARD_DEVIATION 0.21 • n=7 Participants	0.64 index STANDARD_DEVIATION 0.33 • n=5 Participants
Insulin Sensitivity	4.6 index STANDARD_DEVIATION 1.2 • n=5 Participants	5.0 index STANDARD_DEVIATION 2.9 • n=7 Participants	4.8 index STANDARD_DEVIATION 2.05 • n=5 Participants
Body Weight	98.2 kg STANDARD_DEVIATION 14.4 • n=5 Participants	98.9 kg STANDARD_DEVIATION 10.4 • n=7 Participants	98.55 kg STANDARD_DEVIATION 12.4 • n=5 Participants
Body Mass Index	33.4 kg/m^2 STANDARD_DEVIATION 3.3 • n=5 Participants	33.3 kg/m^2 STANDARD_DEVIATION 3.7 • n=7 Participants	33.35 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants
Waist Circumference	111 cm STANDARD_DEVIATION 9 • n=5 Participants	110 cm STANDARD_DEVIATION 13 • n=7 Participants	110.5 cm STANDARD_DEVIATION 11 • n=5 Participants
Triglycerides	1.9 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants	1.9 mmol/L STANDARD_DEVIATION 0.9 • n=7 Participants	1.9 mmol/L STANDARD_DEVIATION 0.95 • n=5 Participants
Total Cholesterol	4.6 mmol/L STANDARD_DEVIATION 1.2 • n=5 Participants	4.5 mmol/L STANDARD_DEVIATION 0.8 • n=7 Participants	4.55 mmol/L STANDARD_DEVIATION 1.0 • n=5 Participants
High Density LIpoprotein cholesterol (HDL-c)	1.1 mmol/L STANDARD_DEVIATION 0.3 • n=5 Participants	1.0 mmol/L STANDARD_DEVIATION 0.2 • n=7 Participants	1.05 mmol/L STANDARD_DEVIATION 0.25 • n=5 Participants
Low density lipoprotein cholesterol (LDL-c)	2.7 mmol/L STANDARD_DEVIATION 0.7 • n=5 Participants	2.6 mmol/L STANDARD_DEVIATION 0.5 • n=7 Participants	2.65 mmol/L STANDARD_DEVIATION 0.6 • n=5 Participants
Systolic Blood Pressure	120 mmHg STANDARD_DEVIATION 8 • n=5 Participants	120 mmHg STANDARD_DEVIATION 10 • n=7 Participants	120 mmHg STANDARD_DEVIATION 9 • n=5 Participants
Diastolic Blood Pressure	81 mmHg STANDARD_DEVIATION 7 • n=5 Participants	76 mmHg STANDARD_DEVIATION 8 • n=7 Participants	78.5 mmHg STANDARD_DEVIATION 7.5 • n=5 Participants
Body Fat	33.3 % STANDARD_DEVIATION 6.6 • n=5 Participants	31.0 % STANDARD_DEVIATION 2.8 • n=7 Participants	32.1 % STANDARD_DEVIATION 4.8 • n=5 Participants
Area under the curve (AUC) glucose	508 mmol*h/L STANDARD_DEVIATION 87 • n=5 Participants	513 mmol*h/L STANDARD_DEVIATION 146 • n=7 Participants	511 mmol*h/L STANDARD_DEVIATION 117 • n=5 Participants
Area under the curve (AUC) insulin	285 pmol*h/L STANDARD_DEVIATION 114 • n=5 Participants	326 pmol*h/L STANDARD_DEVIATION 181 • n=7 Participants	307 pmol*h/L STANDARD_DEVIATION 146 • n=5 Participants

PRIMARY outcome

Timeframe: Fasting glucose at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Fasting Glucose	4.8 mmol/L Standard Deviation 0.6	5.0 mmol/L Standard Deviation 0.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Postprandial Glucose	6.3 mmol/L Standard Deviation 2.1	6.5 mmol/L Standard Deviation 2.3

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
First Phase of Insulin Secretion	1602 index Standard Deviation 800	1194 index Standard Deviation 490

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Total Insulin Secretion	0.52 index Standard Deviation 0.29	0.61 index Standard Deviation 0.27

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Insulin Sensitivity	4.8 index Standard Deviation 3.1	4.9 index Standard Deviation 2.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Area Under the Curve (AUC) Glucose	503 mmol*h/L Standard Deviation 137	522 mmol*h/L Standard Deviation 135

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Area Under the Curve (AUC) Insulin	291 pmol*h/L Standard Deviation 160	262 pmol*h/L Standard Deviation 110

SECONDARY outcome

Timeframe: Body Weight at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Body Weight	99.1 kg Standard Deviation 14.4	98.2 kg Standard Deviation 9.0

SECONDARY outcome

Timeframe: Body Mass Index at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Body Mass Index	33.7 kg/m^2 Standard Deviation 3.3	33.1 kg/m^2 Standard Deviation 3.2

SECONDARY outcome

Timeframe: Waist circumference at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Waist Circumference	112 cm Standard Deviation 9	112 cm Standard Deviation 13

SECONDARY outcome

Timeframe: Triglycerides levels at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Triglycerides	2.3 mmol/L Standard Deviation 1.9	2.4 mmol/L Standard Deviation 2.0

SECONDARY outcome

Timeframe: Total cholesterol levels at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Total Cholesterol	4.4 mmol/L Standard Deviation 0.9	4.3 mmol/L Standard Deviation 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
High Density Lipoprotein Cholesterol (HDL-c)	1.1 mmol/L Standard Deviation 0.2	1.1 mmol/L Standard Deviation 0.2

SECONDARY outcome

Timeframe: LDL-c levels at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Low Density Lipoprotein Cholesterol (LDL-c)	2.3 mmol/L Standard Deviation 0.5	2.2 mmol/L Standard Deviation 0.8

SECONDARY outcome

Timeframe: Systolic Blood Pressure at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Systolic Blood Pressure	120 mmHg Standard Deviation 6	115 mmHg Standard Deviation 8

SECONDARY outcome

Timeframe: Diastolic Blood Pressure at Day 28

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Diastolic Blood Pressure	77 mmHg Standard Deviation 6	73 mmHg Standard Deviation 7

SECONDARY outcome

Timeframe: Body fat at Day 28

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

Outcome measures

Measure	Tadalafil n=9 Participants Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 Participants Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Body Fat	33.7 percentage of fat Standard Deviation 3.3	33.1 percentage of fat Standard Deviation 3.7

Adverse Events

Tadalafil

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tadalafil n=9 participants at risk Tadalafil capsules Tadalafil: Tadalafil capsules: 5 mg, one per day, at night, during 28 days.	Placebo n=9 participants at risk Calcined magnesia capsules Placebo: Calcined magnesia capsules: one per day, at night, during 28 days.
Nervous system disorders Headache	11.1% 1/9 • Number of events 1 • Throughout the study, an average of 28 days	22.2% 2/9 • Number of events 2 • Throughout the study, an average of 28 days
Infections and infestations Chills	11.1% 1/9 • Number of events 1 • Throughout the study, an average of 28 days	0.00% 0/9 • Throughout the study, an average of 28 days
Musculoskeletal and connective tissue disorders Muscle pain	11.1% 1/9 • Number of events 1 • Throughout the study, an average of 28 days	0.00% 0/9 • Throughout the study, an average of 28 days
Renal and urinary disorders Edema	11.1% 1/9 • Number of events 1 • Throughout the study, an average of 28 days	0.00% 0/9 • Throughout the study, an average of 28 days
Nervous system disorders Insomnia	0.00% 0/9 • Throughout the study, an average of 28 days	11.1% 1/9 • Number of events 1 • Throughout the study, an average of 28 days
Gastrointestinal disorders Dyspepsia	0.00% 0/9 • Throughout the study, an average of 28 days	11.1% 1/9 • Number of events 1 • Throughout the study, an average of 28 days

Additional Information

DR. MANUEL GONZALEZ ORTIZ

INSTITUTO DE TERAPEUTICA EXPERIMENTAL Y CLINICA, UNIVERSITY OF GUADALAJARA

Phone: +52 3310585200

Email: uiec@prodigy.net.mx

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place