Trial · NCT02819440

PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction

NCT02819440, Phase 2, Completed, Vanderbilt University Medical Center; results first posted 2022-05-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction. Trials, record NCT02819440. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02819440

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: PDE5 Inhibition for Obesity-Related Cardiometabolic Dysfunction
NCT number: NCT02819440
Status: Completed
Phases: Phase 2
Enrollment: 141 participants, actual
Lead sponsor: Vanderbilt University Medical Center
Conditions: Healthy, Obese
Interventions: Tadalafil, Placebo
First posted: 2016-06-30
Last updated: 2022-05-27
Results first posted: 2022-05-27

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Resting Energy Expenditure After 12 Weeks of Drug Therapy (kcal/Day)	12 weeks	Subjects will undergo a metabolic chamber protocol to measure resting exercise energy expenditure (kcal/min) at 12 weeks adjusted statistically for the baseline measurement.
Primary	Insulin Sensitivity After 12 Weeks of Drug Therapy	12 weeks	Subjects will undergo an insulin modified fasting intravenous glucose tolerance test (FS-IVGTT) protocol at 12 weeks adjusted statistically for the baseline measurement.
Secondary	Physical Activity-induced Energy Expenditure (kcal/Day)	12 weeks	During the metabolic chamber protocol, conducted at baseline and at 12 weeks, the cardiopulmonary exercise test protocol will be conducted. The Energy Expenditure (EE) related to physical activity will be calculated as peak EE above the resting level while performing the exercise test.
Secondary	Dual Energy X-Ray Absorptiometry (DEXA) (g)	12 weeks	fat mass at 12 weeks.
Secondary	Quality of Life Using the Medical Outcomes Study Short-Form Health Survey (SF-36) Physical Component Score	12 weeks	Quality of life will be assessed using the Medical Outcomes Study Short-Form Health Survey (SF-36). The SF-36 is a 36 question survey with a total score range from 0-100; higher scores indicate better quality of life.
Secondary	Change in cGMP/NP Ratio After 12 Weeks of Drug Therapy	12 weeks	Subjects will undergo a fasting blood draw at baseline and 12 weeks to measure the change in ratio of plasma cyclic guanylate monophosphate pathway (cGMP) to plasma natriuretic peptides (NP) in response to the drug intervention (placebo or tadalafil).
Secondary	Maximal Oxygen Consumption	12 weeks	Subjects will undergo a symptom-limited cardiopulmonary exercise test to measure peak oxygen consumption (VO2 max). Maximal oxygen consumption will be measured as 'mL/min'.
Secondary	Sexual Function	12 weeks	The Female Sexual Function Index will be used to measure sexual function in women with a range from 2-36 with higher scores indicating better sexual function.
Secondary	Maximal Exercise Energy Expenditure (kcal/Day)	12 weeks	Subjects will undergo a metabolic chamber protocol to measure maximal exercise energy expenditure (kcal/min) at 12 weeks adjusted statistically for the baseline measurement. Maximal Exercise Energy Expenditure will be measured as "kcal/day"

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Resting Energy Expenditure After 12 Weeks of Drug Therapy (kcal/Day)	12 weeks		kcal/day	MEAN
PRIMARY	Insulin Sensitivity After 12 Weeks of Drug Therapy	12 weeks	Missing data from 2 participants in the Tadalafil arm, 5 participants in the placebo arm caused by inability to obtain intravenous access, which is necessary to make measurements for this endpoint.	ml/kg/min/μIU ml	MEDIAN
SECONDARY	Physical Activity-induced Energy Expenditure (kcal/Day)	12 weeks		kcal/day	MEAN
SECONDARY	Dual Energy X-Ray Absorptiometry (DEXA) (g)	12 weeks		grams	MEAN
SECONDARY	Quality of Life Using the Medical Outcomes Study Short-Form Health Survey (SF-36) Physical Component Score	12 weeks		score on a scale	MEAN
SECONDARY	Change in cGMP/NP Ratio After 12 Weeks of Drug Therapy	12 weeks	Due to lack of funding, the assays required to measure the participant samples were not performed and there is no data to report.
SECONDARY	Maximal Oxygen Consumption	12 weeks		mL/min	MEAN
SECONDARY	Sexual Function	12 weeks	Test only performed in women as designed.	score on a scale	MEAN
SECONDARY	Maximal Exercise Energy Expenditure (kcal/Day)	12 weeks		kcal/day	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Resting Energy Expenditure After 12 Weeks of Drug Therapy (kcal/Day)	Tadalafil	1267	Standard Deviation 133	kcal/day
Resting Energy Expenditure After 12 Weeks of Drug Therapy (kcal/Day)	Placebo	1268	Standard Deviation 164	kcal/day
Insulin Sensitivity After 12 Weeks of Drug Therapy	Tadalafil	1.4	Inter-Quartile Range 1.0 to 2.3	ml/kg/min/μIU ml
Insulin Sensitivity After 12 Weeks of Drug Therapy	Placebo	1.5	Inter-Quartile Range 0.9 to 1.9	ml/kg/min/μIU ml
Physical Activity-induced Energy Expenditure (kcal/Day)	Tadalafil	3320	Standard Deviation 866	kcal/day
Physical Activity-induced Energy Expenditure (kcal/Day)	Placebo	3269	Standard Deviation 714	kcal/day
Dual Energy X-Ray Absorptiometry (DEXA) (g)	Tadalafil	47	Standard Deviation 12	grams
Dual Energy X-Ray Absorptiometry (DEXA) (g)	Placebo	50	Standard Deviation 12	grams
Quality of Life Using the Medical Outcomes Study Short-Form Health Survey (SF-36) Physical Component Score	Tadalafil	52.7	Standard Deviation 5.6	score on a scale
Quality of Life Using the Medical Outcomes Study Short-Form Health Survey (SF-36) Physical Component Score	Placebo	51.0	Standard Deviation 6.9	score on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Tadalafil	61
Overall Study	STARTED	Placebo	64
Overall Study	COMPLETED	Tadalafil	48
Overall Study	COMPLETED	Placebo	52
Overall Study	NOT COMPLETED	Tadalafil	13
Overall Study	NOT COMPLETED	Placebo	12

Source ClinicalTrials.gov

Adverse events44

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Back Pain	Musculoskeletal and connective tissue disorders	Tadalafil	3	61
other	Back Pain	Musculoskeletal and connective tissue disorders	Placebo	1	64
other	Blood in stool	Gastrointestinal disorders	Tadalafil	0	61
other	Blood in stool	Gastrointestinal disorders	Placebo	1	64
other	Vaginal spotting/breakthrough bleeding	Reproductive system and breast disorders	Tadalafil	1	61
other	Vaginal spotting/breakthrough bleeding	Reproductive system and breast disorders	Placebo	1	64
other	Elevated liver enzymes	Hepatobiliary disorders	Tadalafil	0	61
other	Elevated liver enzymes	Hepatobiliary disorders	Placebo	1	64
other	Extremity pain	Musculoskeletal and connective tissue disorders	Tadalafil	4	61
other	Extremity pain	Musculoskeletal and connective tissue disorders	Placebo	2	64

1 to 10 of 44Source ClinicalTrials.gov

See all 44 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Tadalafil	0	61
Total, all-cause mortality	Placebo	0	64
Total, other adverse events	Tadalafil	36	61
Total, other adverse events	Placebo	19	64
Total, serious adverse events	Tadalafil	0	61
Total, serious adverse events	Placebo	0	64

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Tadalafil vs Placebo: deaths from any cause	Trial comparisons
Tadalafil vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02819440

GET https://conductscience.org/api/trials/v1/NCT02819440/events?page=2

API reference For AI assistants