Trial Outcomes & Findings for Lifestyle Intervention and Testosterone Replacement in Obese Seniors (NCT NCT02367105)

Participants were recruited through advertisements and review of medical records at the Michael E DeBakey VA Medical Center.

After obtaining written informed consent, potential participants underwent a comprehensive medical screening procedure, including an exercise stress test. If they were found eligible based on the inclusion/exclusion criteria, they were randomized into one of the two treatment groups.

Lifestyle Intervention and Testosterone Replacement in Obese Seniors

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.

Assessed by measuring peak oxygen consumption using indirect calorimetry during a treadmill exercise stress test

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 after an overnight fast using calibrated scales

Assessed by using dual-energy x-ray absorptiometry

Assessed by using dual-energy x-ray absorptiometry

Assessed by using magnetic resonance imaging

Volume of fat in the thigh by measured by magnetic resonance imaging

Assessed by using dual-energy x-ray absorptiometry

As measured by Dual energy x-ray absorptiometry

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).

assessed by one leg limb stance

Assessed by using the obstacle course

Determined by measuring the time needed to walk 25 ft.

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

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.

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.

Measure of verbal production, semantic memory, and language. Minimum score is 0, there is no maximum value. Higher scores indicate better outcome.

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.

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.

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.

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.

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.

biochemical marker of bone turnover (bone resorption) as measured by immunoassay technique

Biochemical marker of bone turnover (bone formation) as measured by radioimmunoassay technique

Measured by immunoassay methodology

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.

assessed by using immunoassay methodology

Measured by immunoassay methodology as marker of bone metabolism

measured in the peripheral blood using immunoassay technique methodology

Measured from fasting serum using immunoassay technique as marker of inflammation

as measured in the peripheral blood by liquid chromatography/mass spectrometry

As measured by LC-MS/MS

the ratio of the volume of red blood cells to the total volume of blood.

blood test to screen for prostate cancer

Using Short Form-36 of Life Questionnaire Physical Component subscale. Minimum score is 0, Maximum score is 100. Higher scores indicate better outcome.

Using the International Prostate Symptom Scoring (IPS); Minimum score is 0, Maximum score is 35. Higher scores mean worse outcome.

Blood samples obtained in the fasting state as part of measurements of lipid profile

Blood samples obtained in the fasting state as part of measurements of lipid profile

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.

Measured in the blood after overnight fast

Using Yesavage Depression Scale Lower scores indicate better mood (range 0 to 30).

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.

Assessed by using RNA-seq quantification of gene expression in skeletal muscles obtained during muscle biopsies.

assessed by quantitative computed tomography at 4% distal tibia using the following thresholds: 180 mg/cm3 and 45% of the area