Trial · NCT02766478

Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer

NCT02766478, Phase 2, Terminated, Emory University; results first posted 2022-09-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer. Trials, record NCT02766478. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02766478

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Trial

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

Title: Genistein Supplementation to Mitigate Cardiometabolic Dysfunction in Patients Undergoing Androgen Deprivation Therapy for Prostate Cancer
NCT number: NCT02766478
Status: Terminated
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Emory University
Conditions: Prostate Cancer
Interventions: Genistein, Placebo
First posted: 2016-05-09
Last updated: 2022-09-27
Results first posted: 2022-09-27

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline	Baseline, Week 8 post-baseline	The Matsuda index is a measurement of insulin sensitivity from plasma glucose and insulin concentrations during the oral glucose tolerance test (OGTT). Insulin sensitivity was calculated at baseline and after 8 weeks with Matsuda index \[10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)\]. Higher values are reflective of better insulin sensitivity. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin sensitivity or insulin resistance based on this index.
Primary	β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline	Baseline, Week 8 post-baseline	β-cell insulin secretion was determined from the OGTT. It is calculated as the ratio of the change in insulin values over the first 30 minutes of the OGTT and the change in glucose values over the first 30 minutes. Higher values are reflective of higher insulin secretion. This test is not used to clinically diagnose disease, and there is no accepted, standard cutoff to define impaired insulin secretion based on this index.
Secondary	Arterial Stiffness	Baseline, Week 8	Arterial stiffness will be assessed by applanation tonometry. Results will be reported in m/s (meters/seconds). A higher value indicates a worse outcome.
Secondary	Vascular Endothelial Function at Baseline and Week 8 Post-baseline	Baseline, Week 8 post-baseline	Vascular endothelial function was measured with flow-mediated dilation (FMD in %) via ultrasound. A lower FMD indicates a worse outcome.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline	Baseline, Week 8 post-baseline	Number of patients included only subjects that were able to complete the outcome assessment in each visit.	index	MEDIAN
PRIMARY	β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline	Baseline, Week 8 post-baseline	Number of patients included only subjects that were able to complete the outcome assessment in each visit.	index	MEDIAN
SECONDARY	Arterial Stiffness	Baseline, Week 8	Number of patients included only subjects that were able to complete the outcome assessment in each visit.	m/s	MEDIAN
SECONDARY	Vascular Endothelial Function at Baseline and Week 8 Post-baseline	Baseline, Week 8 post-baseline	Number of patients included only subjects that were able to complete the outcome assessment in each visit.	percentage of FMD	MEDIAN

Source ClinicalTrials.gov

Results by group16

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

Outcome	Group	Category	Value	Spread	Units
Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline	Genistein	Baseline	4.4	Inter-Quartile Range 2.4 to 5.5	index
Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline	Placebo	Baseline	6.1	Inter-Quartile Range 3.9 to 13.5	index
Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline	Genistein	8 weeks post-baseline	4.1	Inter-Quartile Range 2.1 to 4.4	index
Matsuda Index of Whole-Body Insulin Sensitivity at Baseline and Week 8 Post-baseline	Placebo	8 weeks post-baseline	7.7	Inter-Quartile Range 5.0 to 10.3	index
β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline	Genistein	Baseline	1.1	Inter-Quartile Range 0.5 to 3.3	index
β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline	Placebo	Baseline	0.7	Inter-Quartile Range 0.5 to 1.3	index
β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline	Genistein	Week 8 post-baseline	2.1	Inter-Quartile Range 0.7 to 2.5	index
β-cell Insulin Secretion Capacity Assessed by the Insulinogenic Index at Baseline and Week 8 Post-baseline	Placebo	Week 8 post-baseline	1.4	Inter-Quartile Range 1.4 to 1.4	index
Arterial Stiffness	Genistein	Baseline	7.4	Inter-Quartile Range 6.1 to 9.2	m/s
Arterial Stiffness	Placebo	Baseline	7.2	Inter-Quartile Range 7.1 to 8.5	m/s

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	Genistein	6
Overall Study	STARTED	Placebo	4
Overall Study	COMPLETED	Genistein	5
Overall Study	COMPLETED	Placebo	3
Overall Study	NOT COMPLETED	Genistein	1
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events46

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	Events
other	Flu	Infections and infestations	Genistein	1	6	1
other	Flu	Infections and infestations	Placebo	0	4	0
other	Fall	Injury, poisoning and procedural complications	Genistein	1	6	1
other	Fall	Injury, poisoning and procedural complications	Placebo	0	4	0
other	Localized edema in feet and ankles	General disorders	Genistein	1	6	1
other	Localized edema in feet and ankles	General disorders	Placebo	0	4	0
other	Sinus congestion	Respiratory, thoracic and mediastinal disorders	Genistein	1	6	1
other	Sinus congestion	Respiratory, thoracic and mediastinal disorders	Placebo	0	4	0
other	Hot flashes	Vascular disorders	Genistein	1	6	1
other	Hot flashes	Vascular disorders	Placebo	0	4	0

1 to 10 of 46Source ClinicalTrials.gov

See all 46 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Genistein	0	6
Total, all-cause mortality	Placebo	0	4
Total, other adverse events	Genistein	5	6
Total, other adverse events	Placebo	4	4
Total, serious adverse events	Genistein	0	6
Total, serious adverse events	Placebo	0	4

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
Genistein vs Placebo: deaths from any cause	Trial comparisons
Genistein 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/NCT02766478

GET https://conductscience.org/api/trials/v1/NCT02766478/events?page=2

API reference For AI assistants