- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02367105
Lifestyle Intervention and Testosterone Replacement in Obese Seniors (LITROS)
Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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)
Exclusion Criteria:
- 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)
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Testosterone plus Lifestyle Therapy
Testosterone replacement in combination with behavioral diet to induce ~10% weight loss + supervised aerobic and exercise training
|
Daily testosterone gel applied once daily in the morning to intact skin
Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week
|
Placebo Comparator: Placebo plus Lifestyle Therapy
Placebo in combination with behavioral diet to induce ~10% weight loss and supervised aerobic and exercise training
|
Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week
Placebo gel for testosterone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Endurance Capacity
Time Frame: Baseline and 6 months
|
Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test
|
Baseline and 6 months
|
Change in Functional Status
Time Frame: 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. |
Baseline and 6 months
|
Change in Body Weight
Time Frame: Baseline and 6 months
|
Measured after an overnight fast using calibrated scales
|
Baseline and 6 months
|
Change in Lean Body Mass
Time Frame: Baseline and 6 months
|
Assessed by using dual-energy x-ray absorptiometry
|
Baseline and 6 months
|
Change in Fat Mass
Time Frame: Baseline and 6 months
|
Assessed by using dual-energy x-ray absorptiometry
|
Baseline and 6 months
|
Change in Thigh Muscle Volume
Time Frame: Baseline and 6 months
|
Assessed by using magnetic resonance imaging
|
Baseline and 6 months
|
Thigh Fat Volume
Time Frame: 6 months
|
Volume of fat in the thigh by measured by magnetic resonance imaging
|
6 months
|
Change in Total Hip Bone Mineral Density
Time Frame: Baseline and 6 months
|
Assessed by using dual-energy x-ray absorptiometry
|
Baseline and 6 months
|
Change in Lumbar Spine Bone Mineral Density
Time Frame: Baseline and 6 months
|
As measured by Dual energy x-ray absorptiometry
|
Baseline and 6 months
|
Change in Muscle Strength
Time Frame: 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).
|
Baseline and 6 months
|
Change in Static Balance
Time Frame: Baseline and 6 months
|
assessed by one leg limb stance
|
Baseline and 6 months
|
Change in Dynamic Balance
Time Frame: Baseline and 6 months
|
Assessed by using the obstacle course
|
Baseline and 6 months
|
Change in Gait Speed
Time Frame: Baseline and 6 months
|
Determined by measuring the time needed to walk 25 ft.
|
Baseline and 6 months
|
Change in Composite Cognitive Z-score
Time Frame: 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 |
Baseline and 6 months
|
Change in Modified Mini-mental Exam
Time Frame: 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.
|
Baseline and 6 months
|
Stroop Interference
Time Frame: 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. |
Baseline and 6 months
|
Change in Word List Fluency
Time Frame: 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.
|
Baseline and 6 months
|
Change in Ray Auditory Verbal Learning Test
Time Frame: 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. |
Baseline and 6 months
|
Change in Trail A
Time Frame: 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. |
Baseline and 6 months
|
Change in Trail B
Time Frame: Baseline and 6 months
|
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. |
Baseline and 6 months
|
Change in Symbol Digital Modalities Test
Time Frame: Baseline and 6 months
|
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. |
Baseline and 6 months
|
Change in Trabecular Bone Score
Time Frame: Baseline and 6 months
|
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. |
Baseline and 6 months
|
Change in C-terminal Telopeptide
Time Frame: Baseline and 6 months
|
biochemical marker of bone turnover (bone resorption) as measured by immunoassay technique
|
Baseline and 6 months
|
Change in N-terminal Propeptide of Type I Procollagen
Time Frame: Baseline and 6 months
|
Biochemical marker of bone turnover (bone formation) as measured by radioimmunoassay technique
|
Baseline and 6 months
|
Change in Insulin Growth Factor-1
Time Frame: Baseline and 6 months
|
Measured by immunoassay methodology
|
Baseline and 6 months
|
Change in Trabecular Bone Score (Trabecular Bone Quality)
Time Frame: Baseline and 6 months
|
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. |
Baseline and 6 months
|
Change in Levels of 25-hydroxyvitamin D
Time Frame: Baseline and 6 months
|
assessed by using immunoassay methodology
|
Baseline and 6 months
|
Change in Parathyroid Hormone Level
Time Frame: Baseline and 6 months
|
Measured by immunoassay methodology as marker of bone metabolism
|
Baseline and 6 months
|
Change in High-sensitivity C-reactive Protein (Inflammatory Marker)
Time Frame: Baseline and 6 months
|
measured in the peripheral blood using immunoassay technique methodology
|
Baseline and 6 months
|
Change in Interleukin-6
Time Frame: Baseline and 6 months
|
Measured from fasting serum using immunoassay technique as marker of inflammation
|
Baseline and 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Total Testosterone Levels
Time Frame: Baseline and 6 months
|
as measured in the peripheral blood by liquid chromatography/mass spectrometry
|
Baseline and 6 months
|
Change in Estradiol
Time Frame: Baseline and 6 months
|
As measured by LC-MS/MS
|
Baseline and 6 months
|
Change in Hematocrit
Time Frame: Baseline and 6 months
|
the ratio of the volume of red blood cells to the total volume of blood.
|
Baseline and 6 months
|
Change in Prostate Specific Antigen
Time Frame: Baseline and 6 months
|
blood test to screen for prostate cancer
|
Baseline and 6 months
|
Change in Short Form Health Survey (SF-36) Quality of Life Physical Component
Time Frame: Baseline and 6 months
|
Using Short Form-36 of Life Questionnaire Physical Component subscale.
Minimum score is 0, Maximum score is 100.
Higher scores indicate better outcome.
|
Baseline and 6 months
|
Change in International Prostate Symptom Score
Time Frame: Baseline and 6 months
|
Using the International Prostate Symptom Scoring (IPS); Minimum score is 0, Maximum score is 35.
Higher scores mean worse outcome.
|
Baseline and 6 months
|
Change in Triglyceride Levels
Time Frame: Baseline and 6 months
|
Blood samples obtained in the fasting state as part of measurements of lipid profile
|
Baseline and 6 months
|
Change in HDL-cholesterol
Time Frame: Baseline and 6 months
|
Blood samples obtained in the fasting state as part of measurements of lipid profile
|
Baseline and 6 months
|
Change in Waist Circumference
Time Frame: Baseline and 6 months
|
Waist circumference as measured horizontally at the midpoint between the highest point of the iliac crest and the lowest portion of the 12th rib in the standing position.
|
Baseline and 6 months
|
Change in Glucose
Time Frame: Baseline and 6 months
|
Measured in the blood after overnight fast
|
Baseline and 6 months
|
Change in Mood
Time Frame: Baseline and 6 months
|
Using Yesavage Depression Scale Lower scores indicate better mood (range 0 to 30).
|
Baseline and 6 months
|
Number of Participants With Significant Changes in Functional Connectivity in the Default Mode Network
Time Frame: Baseline and 6 months
|
Functional connectivity was measured with seeds of the DMN (medial prefrontal cortex [MPFC] and posterior cingulate cortex [PCC]).
Correlation coefficients representing the degree of connectivity between hypothesized regions were Fisher transformed.
An a priori threshold of p<.001 at the voxel level and p<.05, FDR corrected for multiple comparisons across the whole brain, at the cluster level were used to determine significant connectivity.
|
Baseline and 6 months
|
Change in Skeletal Muscle Growth Factor (MYOD1)
Time Frame: Baseline and 6 months
|
Assessed by using RNA-seq quantification of gene expression in skeletal muscles obtained during muscle biopsies.
|
Baseline and 6 months
|
Change in Peripheral Quantitative Computed Tomography Measures (Volumetric Bone Density)
Time Frame: Baseline and 6 months
|
assessed by quantitative computed tomography at 4% distal tibia using the following thresholds: 180 mg/cm3 and 45% of the area
|
Baseline and 6 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDA-034-12F
- CX000906 (Other Grant/Funding Number: VA CSRD)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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