Lifestyle Intervention and Testosterone Replacement in Obese Seniors

NCT02367105, Phase 3, Completed, VA Office of Research and Development; results first posted 2020-08-31

Trial 11

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

Field	Value	Source
Title	Lifestyle Intervention and Testosterone Replacement in Obese Seniors	ClinicalTrials.gov
NCT number	NCT02367105	ClinicalTrials.gov
Status	Completed	ClinicalTrials.gov
Phases	Phase 3	ClinicalTrials.gov
Enrollment	83 participants, actual	ClinicalTrials.gov
Lead sponsor	VA Office of Research and Development	ClinicalTrials.gov
Conditions	Obesity and Hypogonadism	ClinicalTrials.gov
Interventions	Testosterone, Lifestyle Therapy, Placebo	ClinicalTrials.gov
First posted	2015-02-20	ClinicalTrials.gov
Last updated	2022-07-26	ClinicalTrials.gov
Results first posted	2020-08-31	ClinicalTrials.gov

Registered outcomes 45

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

List	Outcome	Time frame	Description	Source
Primary	Change in the Physical Performance Test	Baseline and 6 months	The primary functional outcome is the modified physical performance test, which includes seven standardized tasks (walking 50 ft, putting on and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and performing a progressive Romberg tests) plus two additional tasks (climbing up and down four flights of stairs and performing a 360-degree turn). The score for each task ranges form 0 to 4; a perfect score is 36. Higher scores indicate better physical function.	ClinicalTrials.gov
Secondary	Change in Endurance Capacity	Baseline and 6 months	Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test	ClinicalTrials.gov
Secondary	Change in Functional Status	Baseline and 6 months	Assessed by the Functional Status Questionnaire. Score range: 0 to 36 with higher scores indicating better functional status Provides information of the participants ability to perform activities of daily living.	ClinicalTrials.gov
Secondary	Change in Body Weight	Baseline and 6 months	Measured after an overnight fast using calibrated scales	ClinicalTrials.gov
Secondary	Change in Lean Body Mass	Baseline and 6 months	Assessed by using dual-energy x-ray absorptiometry	ClinicalTrials.gov
Secondary	Change in Fat Mass	Baseline and 6 months	Assessed by using dual-energy x-ray absorptiometry	ClinicalTrials.gov
Secondary	Change in Thigh Muscle Volume	Baseline and 6 months	Assessed by using magnetic resonance imaging	ClinicalTrials.gov
Secondary	Thigh Fat Volume	6 months	Volume of fat in the thigh by measured by magnetic resonance imaging	ClinicalTrials.gov
Secondary	Change in Total Hip Bone Mineral Density	Baseline and 6 months	Assessed by using dual-energy x-ray absorptiometry	ClinicalTrials.gov
Secondary	Change in Lumbar Spine Bone Mineral Density	Baseline and 6 months	As measured by Dual energy x-ray absorptiometry	ClinicalTrials.gov
Secondary	Change in Muscle Strength	Baseline and 6 months	assessed by total1-repetition maximum (the maximal weight lifted at one time; the totals are the sum of the maximal weights lifted in the biceps curl, bench press, 387 seated row, knee extension, knee flexion, and leg press exercises).	ClinicalTrials.gov
Secondary	Change in Static Balance	Baseline and 6 months	assessed by one leg limb stance	ClinicalTrials.gov
Secondary	Change in Dynamic Balance	Baseline and 6 months	Assessed by using the obstacle course	ClinicalTrials.gov
Secondary	Change in Gait Speed	Baseline and 6 months	Determined by measuring the time needed to walk 25 ft.	ClinicalTrials.gov
Secondary	Change in Composite Cognitive Z-score	Baseline and 6 months	Test of overall cognitive performance formed by averaging the standardized scores for several domains of cognitive function (attention, memory, executive, language, global). Higher scores indicate better cognitive status. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean of the baseline scores (units on a scale). Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population	ClinicalTrials.gov
Secondary	Change in Modified Mini-mental Exam	Baseline and 6 months	Test of global cognition with components for orientation, registration, attention, language, praxis, and immediate and delayed memory. Score ranges from 0 to 100 with higher scores indicate better cognition.	ClinicalTrials.gov
Secondary	Stroop Interference	Baseline and 6 months	Assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus feature impedes the simultaneous processing of a second stimulus attribute, well-known as the Stroop Effect. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.	ClinicalTrials.gov
Secondary	Change in Word List Fluency	Baseline and 6 months	Measure of verbal production, semantic memory, and language. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.	ClinicalTrials.gov
Secondary	Change in Ray Auditory Verbal Learning Test	Baseline and 6 months	The Rey Auditory Verbal Learning Test (RAVLT) evaluates a wide diversity of functions: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.	ClinicalTrials.gov
Secondary	Change in Trail A	Baseline and 6 months	Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a greater focus on attention). Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.	ClinicalTrials.gov

Outcomes 45

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

Type	Outcome	Time frame	Units	Measured as	Source
PRIMARY	Change in the Physical Performance Test	Baseline and 6 months	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Endurance Capacity	Baseline and 6 months	ml/kg/min	MEAN	ClinicalTrials.gov
SECONDARY	Change in Functional Status	Baseline and 6 months	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Body Weight	Baseline and 6 months	kilograms	MEAN	ClinicalTrials.gov
SECONDARY	Change in Lean Body Mass	Baseline and 6 months	kg	MEAN	ClinicalTrials.gov
SECONDARY	Change in Fat Mass	Baseline and 6 months	kg	MEAN	ClinicalTrials.gov
SECONDARY	Change in Thigh Muscle Volume	Baseline and 6 months	cm^3	MEAN	ClinicalTrials.gov
SECONDARY	Thigh Fat Volume	6 months	cm^3	MEAN	ClinicalTrials.gov
SECONDARY	Change in Total Hip Bone Mineral Density	Baseline and 6 months	gm/cm^2	MEAN	ClinicalTrials.gov
SECONDARY	Change in Lumbar Spine Bone Mineral Density	Baseline and 6 months	gm/cm^2	MEAN	ClinicalTrials.gov
SECONDARY	Change in Muscle Strength	Baseline and 6 months	kg	MEAN	ClinicalTrials.gov
SECONDARY	Change in Static Balance	Baseline and 6 months	seconds	MEAN	ClinicalTrials.gov
SECONDARY	Change in Dynamic Balance	Baseline and 6 months	seconds	MEAN	ClinicalTrials.gov
SECONDARY	Change in Gait Speed	Baseline and 6 months	m/min	MEAN	ClinicalTrials.gov
SECONDARY	Change in Composite Cognitive Z-score	Baseline and 6 months	z-score	MEAN	ClinicalTrials.gov
SECONDARY	Change in Modified Mini-mental Exam	Baseline and 6 months	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Stroop Interference	Baseline and 6 months	score on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Word List Fluency	Baseline and 6 months	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Ray Auditory Verbal Learning Test	Baseline and 6 months	units on a scale	MEAN	ClinicalTrials.gov
SECONDARY	Change in Trail A	Baseline and 6 months	units on a scale	MEAN	ClinicalTrials.gov

Results by group 92

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

Outcome	Group	Value	Spread	Units	Source
Change in the Physical Performance Test	Placebo + Lifestyle Therapy	4.6	Standard Error 0.3	units on a scale	ClinicalTrials.gov
Change in the Physical Performance Test	Testosterone + Lifestyle Therapy	4.9	Standard Error 0.3	units on a scale	ClinicalTrials.gov
Change in Endurance Capacity	Placebo Plus Lifestyle Therapy	2.8	Standard Error 0.3	ml/kg/min	ClinicalTrials.gov
Change in Endurance Capacity	Testosterone Plus Lifestyle Therapy	4.0	Standard Error 0.3	ml/kg/min	ClinicalTrials.gov
Change in Functional Status	Placebo Plus Lifestyle Therapy	2.9	Standard Error 0.4	units on a scale	ClinicalTrials.gov
Change in Functional Status	Testosterone Plus Lifestyle Therapy	3.1	Standard Error 0.4	units on a scale	ClinicalTrials.gov
Change in Body Weight	Placebo Plus Lifestyle Therapy	-10.6	Standard Error 0.6	kilograms	ClinicalTrials.gov
Change in Body Weight	Testosterone Plus Lifestyle Therapy	-9.8	Standard Error 0.6	kilograms	ClinicalTrials.gov
Change in Lean Body Mass	Placebo Plus Lifestyle Therapy	-2.4	Standard Error 0.2	kg	ClinicalTrials.gov
Change in Lean Body Mass	Testosterone Plus Lifestyle Therapy	-1.2	Standard Error 0.2	kg	ClinicalTrials.gov
Change in Fat Mass	Placebo Plus Lifestyle Therapy	-8.2	Standard Error 0.4	kg	ClinicalTrials.gov
Change in Fat Mass	Testosterone Plus Lifestyle Therapy	-8.0	Standard Error 0.5	kg	ClinicalTrials.gov
Change in Thigh Muscle Volume	Placebo Plus Lifestyle Therapy	-68	Standard Error 10	cm^3	ClinicalTrials.gov
Change in Thigh Muscle Volume	Testosterone Plus Lifestyle Therapy	-25	Standard Error 10	cm^3	ClinicalTrials.gov
Thigh Fat Volume	Placebo Plus Lifestyle Therapy	-292	Standard Error 31	cm^3	ClinicalTrials.gov
Thigh Fat Volume	Testosterone Plus Lifestyle Therapy	-262	Standard Error 32	cm^3	ClinicalTrials.gov
Change in Total Hip Bone Mineral Density	Placebo Plus Lifestyle Therapy	-0.013	Standard Error 0.002	gm/cm^2	ClinicalTrials.gov
Change in Total Hip Bone Mineral Density	Testosterone Plus Lifestyle Therapy	0.007	Standard Error 0.002	gm/cm^2	ClinicalTrials.gov
Change in Lumbar Spine Bone Mineral Density	Placebo Plus Lifestyle Therapy	0.004	Standard Error 0.004	gm/cm^2	ClinicalTrials.gov
Change in Lumbar Spine Bone Mineral Density	Testosterone Plus Lifestyle Therapy	0.007	Standard Error 0.004	gm/cm^2	ClinicalTrials.gov

Participant flow 6

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

Period	Milestone	Group	Participants	Source
Overall Study	STARTED	Placebo + Lifestyle Therapy	41	ClinicalTrials.gov
Overall Study	STARTED	Testosterone + Lifestyle Therapy	42	ClinicalTrials.gov
Overall Study	COMPLETED	Placebo + Lifestyle Therapy	36	ClinicalTrials.gov
Overall Study	COMPLETED	Testosterone + Lifestyle Therapy	34	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Placebo + Lifestyle Therapy	5	ClinicalTrials.gov
Overall Study	NOT COMPLETED	Testosterone + Lifestyle Therapy	8	ClinicalTrials.gov

Adverse events 28

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	Source
other	hypoglycemia, asymptomatic and symptomatic	Metabolism and nutrition disorders	Placebo + Lifestyle Therapy	4	41	4	ClinicalTrials.gov
other	hypoglycemia, asymptomatic and symptomatic	Metabolism and nutrition disorders	Testosterone + Lifestyle Therapy	4	42	4	ClinicalTrials.gov
other	Elevated PSA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Placebo + Lifestyle Therapy	4	41	4	ClinicalTrials.gov
other	Elevated PSA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Testosterone + Lifestyle Therapy	1	42	1	ClinicalTrials.gov
other	Dizziness/orthostasis	Vascular disorders	Placebo + Lifestyle Therapy	4	41	4	ClinicalTrials.gov
other	Dizziness/orthostasis	Vascular disorders	Testosterone + Lifestyle Therapy	1	42	1	ClinicalTrials.gov
serious	Congestive heart failure	Cardiac disorders	Placebo + Lifestyle Therapy	1	41	1	ClinicalTrials.gov
serious	Congestive heart failure	Cardiac disorders	Testosterone + Lifestyle Therapy	1	42	1	ClinicalTrials.gov
serious	Cardiac arrest	Cardiac disorders	Placebo + Lifestyle Therapy	1	41	1	ClinicalTrials.gov
serious	Cardiac arrest	Cardiac disorders	Testosterone + Lifestyle Therapy	0	42	0	ClinicalTrials.gov
serious	Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Placebo + Lifestyle Therapy	0	41	0	ClinicalTrials.gov
serious	Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Testosterone + Lifestyle Therapy	1	42	1	ClinicalTrials.gov
serious	Bleeding peptic ulcer	Gastrointestinal disorders	Placebo + Lifestyle Therapy	1	41	1	ClinicalTrials.gov
serious	Bleeding peptic ulcer	Gastrointestinal disorders	Testosterone + Lifestyle Therapy	0	42	0	ClinicalTrials.gov
serious	Duodenitis	Gastrointestinal disorders	Placebo + Lifestyle Therapy	0	41	0	ClinicalTrials.gov
serious	Duodenitis	Gastrointestinal disorders	Testosterone + Lifestyle Therapy	1	42	1	ClinicalTrials.gov
serious	Cellulitis	Skin and subcutaneous tissue disorders	Placebo + Lifestyle Therapy	1	41	1	ClinicalTrials.gov
serious	Cellulitis	Skin and subcutaneous tissue disorders	Testosterone + Lifestyle Therapy	1	42	1	ClinicalTrials.gov
serious	Acute kidney injury	Renal and urinary disorders	Placebo + Lifestyle Therapy	1	41	1	ClinicalTrials.gov
serious	Acute kidney injury	Renal and urinary disorders	Testosterone + Lifestyle Therapy	0	42	0	ClinicalTrials.gov

Adverse event totals 6

The totals the trial posted for each group.

Total	Group	Affected	At risk	Source
Total, all-cause mortality	Placebo + Lifestyle Therapy	0	41	ClinicalTrials.gov
Total, all-cause mortality	Testosterone + Lifestyle Therapy	0	42	ClinicalTrials.gov
Total, other adverse events	Placebo + Lifestyle Therapy	12	41	ClinicalTrials.gov
Total, other adverse events	Testosterone + Lifestyle Therapy	6	42	ClinicalTrials.gov
Total, serious adverse events	Placebo + Lifestyle Therapy	1	41	ClinicalTrials.gov
Total, serious adverse events	Testosterone + Lifestyle Therapy	1	42	ClinicalTrials.gov

Papers 1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34375393	DERIVED	PubMed

Grants 0

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years	Source

Trial comparisons 2

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

Comparison	Source
Placebo + Lifestyle Therapy vs Testosterone + Lifestyle Therapy: deaths from any cause	Trial comparisons
Placebo + Lifestyle Therapy vs Testosterone + Lifestyle Therapy: serious adverse events	Trial comparisons

Tests 2

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

Test	Named as	Source
Stroop Color-Word Test	Secondary outcome	ConductCognition
Verbal Learning	Secondary outcome	ConductCognition

Source 5

Field	Value	Source
Release	trials-2026-11-12-0.4.0	ClinicalTrials.gov
Release manifest SHA-256	0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4	ClinicalTrials.gov
Registry capture	2026-11-12	ClinicalTrials.gov
Results copy, AACT	2026-03-23	ClinicalTrials.gov
NIH clinical studies file	2026-11-13	ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)