HypogonadismLITENCT03256292
Long-term Lifestyle Change and Testosterone Replacement
An observational study of Hypogonadism and Aging, run by Baylor College of Medicine at 1 site in United States.
Trial summary
Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling… Read more about this study
- Who is it for?
- Ages 65 to 85 years, men only
- Conditions the study is for
- Hypogonadism, Aging, Overweight and Obesity
- What is being tested?
- Testosterone replacement and lifestyle
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2017to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Older adults with hypogonadism following lifestyle change (diet and exercise on their own for at least one year) with testosterone replacement therapy.
Who may be able to join
- Overweight/obese (BMI = or > 27 kg/m2)
- Older (65-85 yr)
- Male veteran patients being seen at the PI's endocrine clinic and receiving standard of care consisting of diet and regular exercise counseling
- Diagnosed with hypogonadism on current or previous testosterone replacement at the PI's endocrine clinic
- Willing to provide informed consent
Who cannot join
- Failure to provide informed consent
- Unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable disease (Class III or IV congestive heart failure).
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
About this study
Official title: Long-term Lifestyle Change in Obese Older Veterans
Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy. This study will determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults.
Read the detailed description
Background: There are studies on long-term testosterone replacement in older adults with hypogonadism showing benefits on body composition, sexual function and mood but not on testosterone replacement therapy in combination with lifestyle change (diet-induced weight loss and exercise) in the specific population of older adults with both obesity and hypogonadism.
Purpose: To determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults .
Design: Overweight/obese older veteran patients with obesity and hypogonadism who are being followed at the endocrine clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body composition testing.
- Conditions
- Hypogonadism, Aging, Overweight and Obesity
- Being tested
- Testosterone replacement, lifestyle
- Medical subject headings
- Hypogonadism, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone replacementDrug
Testosterone replacement therapy
lifestyleBehavioural
lifestyle intervention consisting of diet and increased physical activity
| Study group | Role | What they receive |
|---|---|---|
| testosterone, diet, and increased physical activity | Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy Receives: Drug: Testosterone replacement; Behavioral: lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physical Performance Test score
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.
Measured: 18 month
Change in body weight
Measured after an overnight fast using calibrated scales
Measured: 18 month
Secondary outcomes (36)
Change in body composition (lean mass, fat mass and bone mineral density)
Assessed by using dual-energy x-ray absorptiometry
Measured: 18 month
Volumetric BMD
Assessed by using peripheral quantitative computed tomography (pQCT)
Measured: 18 month
Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)
measured by ELISA
Measured: 18 month
Change in prostate specific antigen
measured in the blood
Measured: 18 month
Prostate Symptom Assessment
Using the International Prostate Symptom Scoring
Measured: 18 month
Mood
Using the Geriatric Depression Scale
Measured: 18 month
Quality of Life
Using SF-36 and impact of weight on quality of life short form (IWQOL-lite)
Measured: 18 month
Sexual function
Using the International Index of Erectile Function
Measured: 18 month
Change in trabecular bone score
Using DXA
Measured: 18 month
Change in muscle strength and quality
Using biodex dynamometry
Measured: 18 month
Change in balance
as measured by leg stance and obstacle course
Measured: 18 month
Change in Functional Status
Using functional status questionnaire
Measured: 18 month
Change in gait
as measured by completing the time to walk a certain distance
Measured: 18 month
Change in bone quality
Using HrpQCT
Measured: 18 month
Change in testosterone level
as measured in the blood
Measured: 18 month
Change in sex hormone globulin
as measured in the blood
Measured: 18 month
Change in metabolic hormones
Leptin, adiponectin, and similar metabolic hormones as measured in the blood
Measured: 18 month
Change in Composite cognitive z-score
using cognitive instrument testing
Measured: 18 month
Change in Modified mini-mental exam
using cognitive instrument testing
Measured: 18 month
Change in Stroop color naming
using cognitive instrument testing
Measured: 18 month
Change in Word list fluency
using cognitive instrument testing
Measured: 18 month
Change in Ray auditory verbal learning test
using cognitive instrument testing
Measured: 18 month
Change in Trail A/B
using cognitive instrument testing
Measured: 18 month
Change in waist circumference
as measured
Measured: 18 month
Change in serum PTH
as measured in the blood
Measured: 18 month
Change in lipid profile
as measured in the blood
Measured: 18 month
Change in blood pressure
as measured by sphygmomanometry
Measured: 18 month
Change in metabolic syndrome
using harmonized metabolic syndrome criteria
Measured: 18 month
bone strength index
assessed by pQCT
Measured: 18 months
Cortical to total area
assessed by pQCT
Measured: 18 months
Change in density weighted polar section modulus
assessed by pQCT
Measured: 18 months
Change in cortical density
assessed by pQCT
Measured: 18 months
Change in cortical area
assessed by pQCT
Measured: 18 months
Change in Biochemical Markers of Bone Turnover (PINP)
measured by RIA
Measured: 18 months
Change in lipid profile
measured in the blood
Measured: 18 months
Change in vitamin D level
measured in the blood
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start21 Aug 2017
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypogonadismStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dennis T. Villareal, Baylor College of Medicine
- Investigators
- Dennis T Villareal, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256292
- Sponsor's protocol ID
- H-40598
- Acronym
- LITE
- Status last verified
- Mar 2021
- First submitted
- 16 Aug 2017
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: A De-identified, Anonymized Dataset will be created and shared. NOTE: ORO recommends that such sharing take place under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Lifestyle Change in Obese Older Veterans
- ClinicalTrials.gov ID
- NCT03256292
- Acronym / sponsor ID
- LITE / H-40598
- Conditions
- Hypogonadism, Aging, Overweight and Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older hypogonadal obese veterans previously participated in a 6 month lifestyle change (diet-induced weight loss and exercise) study with or without testosterone replacement therapy before being followed for the following year at the clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy. This study will determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults.
Detailed description
Background: There are studies on long-term testosterone replacement in older adults with hypogonadism showing benefits on body composition, sexual function and mood but not on testosterone replacement therapy in combination with lifestyle change (diet-induced weight loss and exercise) in the specific population of older adults with both obesity and hypogonadism.
Purpose: To determine if long-term lifestyle change and testosterone replacement therapy with associated improvement in physical and metabolic health can be maintained in obese older adults .
Design: Overweight/obese older veteran patients with obesity and hypogonadism who are being followed at the endocrine clinic while receiving standard of care consisting of diet and exercise counseling (for healthy lifestyle change) and testosterone replacement therapy will be recruited for testing of physical, metabolic, cognitive/mood, quality of life, and body composition testing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| testosterone, diet, and increased physical activity | – | Drug: Testosterone replacement, Behavioral: lifestyleGroup receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older adults with hypogonadism following lifestyle change (diet and exercise on their own for at least one year) with testosterone replacement therapy.
Key inclusion criteria (5 listed)
- Overweight/obese (BMI = or > 27 kg/m2)
- Older (65-85 yr)
- Male veteran patients being seen at the PI's endocrine clinic and receiving standard of care consisting of diet and regular exercise counseling
- Diagnosed with hypogonadism on current or previous testosterone replacement at the PI's endocrine clinic
- Willing to provide informed consent
Key exclusion criteria (2 listed)
- Failure to provide informed consent
- Unstable cardiopulmonary disease (e.g. recent MI, unstable angina, stroke) or unstable disease (Class III or IV congestive heart failure).
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 |
|---|---|---|
| Testosterone replacementTestosterone replacement therapy | Drug | testosterone, diet, and increased physical activity |
| lifestylelifestyle intervention consisting of diet and increased physical activity | Behavioural | testosterone, diet, and increased physical activity |
Primary outcome
Change in Physical Performance Test score
Time frame: 18 month
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.
Change in body weight
Time frame: 18 month
Measured after an overnight fast using calibrated scales
36 secondary outcomes
Change in body composition (lean mass, fat mass and bone mineral density)
Time frame: 18 month
Volumetric BMD
Time frame: 18 month
Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)
Time frame: 18 month
Change in prostate specific antigen
Time frame: 18 month
Prostate Symptom Assessment
Time frame: 18 month
Mood
Time frame: 18 month
Quality of Life
Time frame: 18 month
Sexual function
Time frame: 18 month
Change in trabecular bone score
Time frame: 18 month
Change in muscle strength and quality
Time frame: 18 month
Change in balance
Time frame: 18 month
Change in Functional Status
Time frame: 18 month
Change in gait
Time frame: 18 month
Change in bone quality
Time frame: 18 month
Change in testosterone level
Time frame: 18 month
Change in sex hormone globulin
Time frame: 18 month
Change in metabolic hormones
Time frame: 18 month
Change in Composite cognitive z-score
Time frame: 18 month
Change in Modified mini-mental exam
Time frame: 18 month
Change in Stroop color naming
Time frame: 18 month
Change in Word list fluency
Time frame: 18 month
Change in Ray auditory verbal learning test
Time frame: 18 month
Change in Trail A/B
Time frame: 18 month
Change in waist circumference
Time frame: 18 month
Change in serum PTH
Time frame: 18 month
Change in lipid profile
Time frame: 18 month
Change in blood pressure
Time frame: 18 month
Change in metabolic syndrome
Time frame: 18 month
bone strength index
Time frame: 18 months
Cortical to total area
Time frame: 18 months
Change in density weighted polar section modulus
Time frame: 18 months
Change in cortical density
Time frame: 18 months
Change in cortical area
Time frame: 18 months
Change in Biochemical Markers of Bone Turnover (PINP)
Time frame: 18 months
Change in lipid profile
Time frame: 18 months
Change in vitamin D level
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Individual participant dataSharing planned: Yes. A De-identified, Anonymized Dataset will be created and shared. NOTE: ORO recommends that such sharing take place under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.
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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
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypogonadism and Aging, run by Baylor College of Medicine 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 5 inclusion and 2 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 10 Mar 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Physical Performance Test score (time frame: 18 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2021.