Obesity and HypogonadismPhase 3LITROSNCT02367105
Lifestyle Intervention and Testosterone Replacement in Obese Seniors
A Phase 3 study testing Testosterone and Lifestyle Therapy in people with Obesity and Hypogonadism, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. Read more about this study
- Who is it for?
- Ages 65 to 85 years, men only
- Conditions the study is for
- Obesity and Hypogonadism
- What is being tested?
- Testosterone and Lifestyle Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 31 Dec 2019
- Phase
- Phase 3
- 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 65 to 85 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects will be
- older (65-85 yr)
- obese (BMI 30 kg/m2 or greater) Veteran men with low testosterone (less than 300 mg/dL) as defined by the Endocrine Society
- mild to moderately frail
- must have stable weight (~not less than or more than 2 kg) during the last 6 months
- sedentary (regular exercise less than 1 h/week or less than 2x/week for the last 6 months)
Who cannot join
- Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
- Examples include, but are not limited to:
- cardiopulmonary disease (e.g. recent myocardial infarction (MI), unstable angina, stroke etc) or unstable disease (e.g. CHF)
- severe orthopedic/musculoskeletal or neuromuscular impairments
- visual or hearing impairments
- cognitive impairment (Mini Mental State Exam Score less than 24)
Show all 17Show fewer
- current use of bone active drugs
- uncontrolled diabetes (i.e. fasting blood glucose more than 140 mg/dl and/or HbA1c greater than 9.5%).
- Any contraindications to testosterone supplementation
- history of prostate or breast cancer
- history of testicular disease
- untreated sleep apnea
- hematocrit more than 50%
- prostate-related findings of palpable nodule on exam, a serum PSA of 4.0 ng/ml or greater
- International Prostate Symptom Sore more than 19
- history of venous thromboembolism
- Osteoporosis or a BMD T-score of -2.5 in the lumbar spine or total hip as well as those patients with a history of osteoporosis-related fracture (spine, hip, or wrist)
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030
About this study
Official title: Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans
The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates the age- related decline in physical function and causes frailty which predisposes to admission to a VA chronic care facility. However, the optimal clinical approach to obesity in older adults is controversial because of the concern that weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and reverse frailty in obese older Veterans and thus prevent their loss of independence and decrease demand for VA health care services.
Read the detailed description
Obesity is not only highly prevalent among Americans, but even more so among Veterans using VA medical facilities. Failure to assist Veterans in managing weight and sedentary lifestyle affects current treatment and increases future demand for VA health care services. Decreased muscle mass with aging and the need to carry extra mass due to obesity make it particularly difficult for obese older Veterans to function independently and results in frailty leading to increased nursing home admissions and increased morbidity and mortality. Data from preliminary studies showed that lifestyle therapy resulting in weight loss in this understudied population improves physical function and ameliorates frailty. However, this improvement in physical function is modest at best and most obese older adults remain physically frail. More importantly, there are concerns that lifestyle therapy may exacerbate underlying sarcopenia and osteopenia from weight loss- induced loss of lean body mass and bone mineral density (BMD). As a result, most geriatricians are reluctant to recommend lifestyle therapy that includes weight loss in obese frail elderly patients although the combination of weight loss and exercise is recommended as part of standard care for obese patients in general. Thus, it is not surprising that among Veterans, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. In addition to overeating and lack of exercise, age-related decline in anabolic hormone (i.e. testosterone) may contribute to sarcopenia and osteopenia, which in turn is exacerbated by obesity. Indeed, preliminary studies discovered that obese older men had markedly low levels of serum testosterone at baseline which remained low throughout the duration of lifestyle therapy. Because testosterone replacement therapy has been shown to increase muscle mass and BMD, it is therefore likely that concomitant testosterone replacement during lifestyle therapy in obese older adults would preserve lean body mass and BMD, and reverse frailty. Accordingly, the optimal management to the problem of sarcopenic obesity and frailty might require a comprehensive approach of a combination of lifestyle intervention and the correction of anabolic hormone deficiency. Therefore, the primary goal of this proposal is to conduct a randomized, comparative efficacy, double-blind, placebo-controlled (for testosterone) trial of the effects of 1) lifestyle therapy (1% diet-induced weight loss and exercise training) + testosterone replacement therapy versus 2) lifestyle therapy without testosterone replacement (testosterone placebo) in obese (BMI e 30 kg/m2) older (age e 65 yrs) male Veterans. The investigators hypothesize that 1) lifestyle therapy + testosterone replacement will cause a greater improvement in physical function than lifestyle therapy without concomitant testosterone replacement; 2) lifestyle therapy + testosterone replacement will cause a greater preservation of fat-free mass and thigh muscle volume than lifestyle therapy without testosterone replacement, 3) lifestyle therapy + testosterone replacement will cause a greater preservation in BMD and bone quality than lifestyle therapy without testosterone replacement, and 4) lifestyle therapy + testosterone replacement will cause a greater reduction in intramuscular proinflammatory cytokines than lifestyle therapy without testosterone replacement. The overarching hypothesis across aims is that a multifactorial intervention by means of lifestyle therapy plus testosterone replacement will be the most effective approach for reversing sarcopenic obesity and frailty in obese older male adults, as mediated by their additive effects in suppressing chronic inflammation, and stimulating muscle and bone anabolism. Obesity in older adults, including many aging Veterans, is a major public health problem. In fact, the public health success that has occurred in recent years could be in danger if lifestyles of older adults are neglected. The novel health outcomes and mechanistic-based data generated from this proposed randomized clinical trial (RCT) will have important ramifications for the standard of care for this rapidly increasing segment of the aging Veteran population.
- Conditions
- Obesity and Hypogonadism
- Being tested
- Testosterone, Lifestyle Therapy, Placebo
- Keywords
- Obesity, Hypogonadism, Frailty
- Medical subject headings
- Obesity, Hypogonadism, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestosteroneDrug
Daily testosterone gel applied once daily in the morning to intact skin
Lifestyle TherapyOther
Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week
PlaceboDrug
Placebo gel for testosterone
| Study group | Role | What they receive |
|---|---|---|
| Testosterone plus Lifestyle Therapy | Active comparator | Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training Receives: Drug: Testosterone; Other: Lifestyle Therapy |
| Placebo plus Lifestyle Therapy | Placebo comparator | Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training Receives: Other: Lifestyle Therapy; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Physical Performance Test
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.
Measured: Baseline and 6 months
Secondary outcomes (30)
Change in Endurance Capacity
Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test
Measured: Baseline and 6 months
Change in Functional Status
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.
Measured: Baseline and 6 months
Change in Body Weight
Measured after an overnight fast using calibrated scales
Measured: Baseline and 6 months
Change in Lean Body Mass
Assessed by using dual-energy x-ray absorptiometry
Measured: Baseline and 6 months
Change in Fat Mass
Assessed by using dual-energy x-ray absorptiometry
Measured: Baseline and 6 months
Change in Thigh Muscle Volume
Assessed by using magnetic resonance imaging
Measured: Baseline and 6 months
Thigh Fat Volume
Volume of fat in the thigh by measured by magnetic resonance imaging
Measured: 6 months
Change in Total Hip Bone Mineral Density
Assessed by using dual-energy x-ray absorptiometry
Measured: Baseline and 6 months
Change in Lumbar Spine Bone Mineral Density
As measured by Dual energy x-ray absorptiometry
Measured: Baseline and 6 months
Change in Muscle Strength
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).
Measured: Baseline and 6 months
Change in Static Balance
assessed by one leg limb stance
Measured: Baseline and 6 months
Change in Dynamic Balance
Assessed by using the obstacle course
Measured: Baseline and 6 months
Change in Gait Speed
Determined by measuring the time needed to walk 25 ft.
Measured: Baseline and 6 months
Change in Composite Cognitive Z-score
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
Measured: Baseline and 6 months
Change in Modified Mini-mental Exam
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.
Measured: Baseline and 6 months
Stroop Interference
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.
Measured: Baseline and 6 months
Change in Word List Fluency
Measure of verbal production, semantic memory, and language. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.
Measured: Baseline and 6 months
Change in Ray Auditory Verbal Learning Test
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.
Measured: Baseline and 6 months
Change in Trail A
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.
Measured: Baseline and 6 months
Change in Trail B
Test of visuospatial scanning, speed of processing, mental flexibility, and executive function (with a focus on executive function)
Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.
Measured: Baseline and 6 months
Change in Symbol Digital Modalities Test
Assesses key neurocognitive functions that underlie many substitution tasks, including attention, visual scanning, and motor speed.
Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.
Measured: Baseline and 6 months
Change in Trabecular Bone Score
The trabecular bone score is a measure of bone texture correlated with bone microarchitecture and a marker for the risk of osteoporosis.
Minimum score is 0, there is no maximum value. Higher scores indicate better bone microarchitecture.
Measured: Baseline and 6 months
Change in C-terminal Telopeptide
biochemical marker of bone turnover (bone resorption) as measured by immunoassay technique
Measured: Baseline and 6 months
Change in N-terminal Propeptide of Type I Procollagen
Biochemical marker of bone turnover (bone formation) as measured by radioimmunoassay technique
Measured: Baseline and 6 months
Change in Insulin Growth Factor-1
Measured by immunoassay methodology
Measured: Baseline and 6 months
Change in Trabecular Bone Score (Trabecular Bone Quality)
assessed by trabecular bone score (TBS), a newly developed index for assessing trabecular bone quality and fracture risk.
TBS is a bone texture parameter that quantifies cancellous bone microachitecture, which is key in determining bone strength and resistance to fracture, by computing raw data from dual energy x-ray absorptiometry of the lumbar spine.
There are no minimum or maximum values. Higher scores mean better outcome.
Measured: Baseline and 6 months
Change in Levels of 25-hydroxyvitamin D
assessed by using immunoassay methodology
Measured: Baseline and 6 months
Change in Parathyroid Hormone Level
Measured by immunoassay methodology as marker of bone metabolism
Measured: Baseline and 6 months
Change in High-sensitivity C-reactive Protein (Inflammatory Marker)
measured in the peripheral blood using immunoassay technique methodology
Measured: Baseline and 6 months
Change in Interleukin-6
Measured from fasting serum using immunoassay technique as marker of inflammation
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2015 (estimated)
- Study start1 Feb 2015
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and HypogonadismStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center, Baylor College of Medicine, Biomedical Research Institute of New Mexico
- Responsible party
- Sponsor
- Investigators
- Dennis T Villareal, MD, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02367105
- Sponsor's protocol ID
- ENDA-034-12F
- Other IDs
- CX000906
- Acronym
- LITROS
- Status last verified
- Jan 2022
- First submitted
- 21 Jan 2015
- Last updated
- 26 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication (guidance is provided on the ORD website). MEDVAMC will not provide unrestricted, open public access to large scale health related datasets because of re-identification concerns and the obligation to protect Veterans' private information. However, controlled public access will be provided to the greatest extent possible under specific DUAs or other written agreements, and open access will be provided to the final datasets underlying peer-reviewed publications (aggregated data that can be released with privacy and confidentiality risks).
Publications
Gregori G, Celli A, Barnouin Y, Paudyal A, Armamento-Villareal R, Napoli N, Qualls C, Villareal DT. Cognitive response to testosterone replacement added to intensive lifestyle intervention in older men with obesity and hypogonadism: prespecified secondary analyses of a randomized clinical trial. Am J Clin Nutr. 2021 Nov 8;114(5):1590-1599. doi: 10.1093/ajcn/nqab253.
PubMed 34375393
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans
- ClinicalTrials.gov ID
- NCT02367105
- Acronym / sponsor ID
- LITROS / ENDA-034-12F
- Conditions
- Obesity and Hypogonadism
- Keywords
- Obesity, Hypogonadism, Frailty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Michael E. DeBakey VA Medical Center, Baylor College of Medicine, Biomedical Research Institute of New Mexico
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Feb 2015 (estimated)
- Results
- Posted 31 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates the age- related decline in physical function and causes frailty which predisposes to admission to a VA chronic care facility. However, the optimal clinical approach to obesity in older adults is controversial because of the concern that weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and reverse frailty in obese older Veterans and thus prevent their loss of independence and decrease demand for VA health care services.
Detailed description
Obesity is not only highly prevalent among Americans, but even more so among Veterans using VA medical facilities. Failure to assist Veterans in managing weight and sedentary lifestyle affects current treatment and increases future demand for VA health care services. Decreased muscle mass with aging and the need to carry extra mass due to obesity make it particularly difficult for obese older Veterans to function independently and results in frailty leading to increased nursing home admissions and increased morbidity and mortality. Data from preliminary studies showed that lifestyle therapy resulting in weight loss in this understudied population improves physical function and ameliorates frailty. However, this improvement in physical function is modest at best and most obese older adults remain physically frail. More importantly, there are concerns that lifestyle therapy may exacerbate underlying sarcopenia and osteopenia from weight loss- induced loss of lean body mass and bone mineral density (BMD). As a result, most geriatricians are reluctant to recommend lifestyle therapy that includes weight loss in obese frail elderly patients although the combination of weight loss and exercise is recommended as part of standard care for obese patients in general. Thus, it is not surprising that among Veterans, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. In addition to overeating and lack of exercise, age-related decline in anabolic hormone (i.e. testosterone) may contribute to sarcopenia and osteopenia, which in turn is exacerbated by obesity. Indeed, preliminary studies discovered that obese older men had markedly low levels of serum testosterone at baseline which remained low throughout the duration of lifestyle therapy. Because testosterone replacement therapy has been shown to increase muscle mass and BMD, it is therefore likely that concomitant testosterone replacement during lifestyle therapy in obese older adults would preserve lean body mass and BMD, and reverse frailty. Accordingly, the optimal management to the problem of sarcopenic obesity and frailty might require a comprehensive approach of a combination of lifestyle intervention and the correction of anabolic hormone deficiency. Therefore, the primary goal of this proposal is to conduct a randomized, comparative efficacy, double-blind, placebo-controlled (for testosterone) trial of the effects of 1) lifestyle therapy (1% diet-induced weight loss and exercise training) + testosterone replacement therapy versus 2) lifestyle therapy without testosterone replacement (testosterone placebo) in obese (BMI e 30 kg/m2) older (age e 65 yrs) male Veterans. The investigators hypothesize that 1) lifestyle therapy + testosterone replacement will cause a greater improvement in physical function than lifestyle therapy without concomitant testosterone replacement; 2) lifestyle therapy + testosterone replacement will cause a greater preservation of fat-free mass and thigh muscle volume than lifestyle therapy without testosterone replacement, 3) lifestyle therapy + testosterone replacement will cause a greater preservation in BMD and bone quality than lifestyle therapy without testosterone replacement, and 4) lifestyle therapy + testosterone replacement will cause a greater reduction in intramuscular proinflammatory cytokines than lifestyle therapy without testosterone replacement. The overarching hypothesis across aims is that a multifactorial intervention by means of lifestyle therapy plus testosterone replacement will be the most effective approach for reversing sarcopenic obesity and frailty in obese older male adults, as mediated by their additive effects in suppressing chronic inflammation, and stimulating muscle and bone anabolism. Obesity in older adults, including many aging Veterans, is a major public health problem. In fact, the public health success that has occurred in recent years could be in danger if lifestyles of older adults are neglected. The novel health outcomes and mechanistic-based data generated from this proposed randomized clinical trial (RCT) will have important ramifications for the standard of care for this rapidly increasing segment of the aging Veteran population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Testosterone plus Lifestyle Therapy | Active comparator | Drug: Testosterone, Other: Lifestyle TherapyTestosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training |
| Placebo plus Lifestyle Therapy | Placebo comparator | Other: Lifestyle Therapy, Drug: PlaceboPlacebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Subjects will be
- older (65-85 yr)
- obese (BMI 30 kg/m2 or greater) Veteran men with low testosterone (less than 300 mg/dL) as defined by the Endocrine Society
- mild to moderately frail
- must have stable weight (~not less than or more than 2 kg) during the last 6 months
Key exclusion criteria (17 listed)
- Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
- Examples include, but are not limited to:
- Any contraindications to testosterone supplementation
- Osteoporosis or a BMD T-score of -2.5 in the lumbar spine or total hip as well as those patients with a history of osteoporosis-related fracture (spine, hip, or wrist)
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 |
|---|---|---|
| TestosteroneDaily testosterone gel applied once daily in the morning to intact skin | Drug | Testosterone plus Lifestyle Therapy |
| Lifestyle TherapyWeekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week | Other | Placebo plus Lifestyle Therapy, Testosterone plus Lifestyle Therapy |
| PlaceboPlacebo gel for testosterone | Drug | Placebo plus Lifestyle Therapy |
Primary outcome
Change in the Physical Performance Test
Time frame: 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.
30 secondary outcomes
Change in Endurance Capacity
Time frame: Baseline and 6 months
Change in Functional Status
Time frame: Baseline and 6 months
Change in Body Weight
Time frame: Baseline and 6 months
Change in Lean Body Mass
Time frame: Baseline and 6 months
Change in Fat Mass
Time frame: Baseline and 6 months
Change in Thigh Muscle Volume
Time frame: Baseline and 6 months
Thigh Fat Volume
Time frame: 6 months
Change in Total Hip Bone Mineral Density
Time frame: Baseline and 6 months
Change in Lumbar Spine Bone Mineral Density
Time frame: Baseline and 6 months
Change in Muscle Strength
Time frame: Baseline and 6 months
Change in Static Balance
Time frame: Baseline and 6 months
Change in Dynamic Balance
Time frame: Baseline and 6 months
Change in Gait Speed
Time frame: Baseline and 6 months
Change in Composite Cognitive Z-score
Time frame: Baseline and 6 months
Change in Modified Mini-mental Exam
Time frame: Baseline and 6 months
Stroop Interference
Time frame: Baseline and 6 months
Change in Word List Fluency
Time frame: Baseline and 6 months
Change in Ray Auditory Verbal Learning Test
Time frame: Baseline and 6 months
Change in Trail A
Time frame: Baseline and 6 months
Change in Trail B
Time frame: Baseline and 6 months
Change in Symbol Digital Modalities Test
Time frame: Baseline and 6 months
Change in Trabecular Bone Score
Time frame: Baseline and 6 months
Change in C-terminal Telopeptide
Time frame: Baseline and 6 months
Change in N-terminal Propeptide of Type I Procollagen
Time frame: Baseline and 6 months
Change in Insulin Growth Factor-1
Time frame: Baseline and 6 months
Change in Trabecular Bone Score (Trabecular Bone Quality)
Time frame: Baseline and 6 months
Change in Levels of 25-hydroxyvitamin D
Time frame: Baseline and 6 months
Change in Parathyroid Hormone Level
Time frame: Baseline and 6 months
Change in High-sensitivity C-reactive Protein (Inflammatory Marker)
Time frame: Baseline and 6 months
Change in Interleukin-6
Time frame: Baseline and 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34375393Gregori G, Celli A, Barnouin Y, Paudyal A, Armamento-Villareal R, Napoli N, Qualls C, Villareal DT. Cognitive response to testosterone replacement added to intensive lifestyle intervention in older men with obesity and hypogonadism: prespecified secondary analyses of a randomized clinical trial. Am J Clin Nutr. 2021 Nov 8;114(5):1590-1599. doi: 10.1093/ajcn/nqab253.
- Individual participant dataSharing planned: No. Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication (guidance is provided on the ORD website). MEDVAMC will not provide unrestricted, open public access to large scale health related datasets because of re-identification concerns and the obligation to protect Veterans' private information. However, controlled public access will be provided to the greatest extent possible under specific DUAs or other written agreements, and open access will be provided to the final datasets underlying peer-reviewed publications (aggregated data that can be released with privacy and confidentiality risks).
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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.
Dennis T Villareal, MD principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Testosterone and Lifestyle Therapy in people with Obesity and Hypogonadism, run by VA Office of Research and Development at 1 site in United States.
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 6 inclusion and 17 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 26 Jul 2022. 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 United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 31 Aug 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?
Change in the Physical Performance Test (time frame: Baseline and 6 months). 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 NCT02367105, which also lists 1 linked publication.
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 26 Jul 2022.