Clinical trial NCT03256292: Long-term Lifestyle Change and Testosterone Replacement
Official title: Long-term Lifestyle Change in Obese Older Veterans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypogonadism
Aging
Overweight and Obesity
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 38
Sex: MALE
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Older adults with hypogonadism following lifestyle change (diet and exercise on their own for at least one year) with testosterone replacement therapy.

Brief 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 (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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in Physical Performance Test score
timeFrame: 18 month
measure: Change in body weight
timeFrame: 18 month
Secondary outcomes:
measure: Change in body composition (lean mass, fat mass and bone mineral density)
timeFrame: 18 month
measure: Volumetric BMD
timeFrame: 18 month
measure: Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)
timeFrame: 18 month
measure: Change in prostate specific antigen
timeFrame: 18 month
measure: Prostate Symptom Assessment
timeFrame: 18 month
measure: Mood
timeFrame: 18 month
measure: Quality of Life
timeFrame: 18 month
measure: Sexual function
timeFrame: 18 month
measure: Change in trabecular bone score
timeFrame: 18 month
measure: Change in muscle strength and quality
timeFrame: 18 month
measure: Change in balance
timeFrame: 18 month
measure: Change in Functional Status
timeFrame: 18 month
measure: Change in gait
timeFrame: 18 month
measure: Change in bone quality
timeFrame: 18 month
measure: Change in testosterone level
timeFrame: 18 month
measure: Change in sex hormone globulin
timeFrame: 18 month
measure: Change in metabolic hormones
timeFrame: 18 month
measure: Change in Composite cognitive z-score
timeFrame: 18 month
measure: Change in Modified mini-mental exam
timeFrame: 18 month
measure: Change in Stroop color naming
timeFrame: 18 month
measure: Change in Word list fluency
timeFrame: 18 month
measure: Change in Ray auditory verbal learning test
timeFrame: 18 month
measure: Change in Trail A/B
timeFrame: 18 month
measure: Change in waist circumference
timeFrame: 18 month
measure: Change in serum PTH
timeFrame: 18 month
measure: Change in lipid profile
timeFrame: 18 month
measure: Change in blood pressure
timeFrame: 18 month
measure: Change in metabolic syndrome
timeFrame: 18 month
measure: bone strength index
timeFrame: 18 months
measure: Cortical to total area
timeFrame: 18 months
measure: Change in density weighted polar section modulus
timeFrame: 18 months
measure: Change in cortical density
timeFrame: 18 months
measure: Change in cortical area
timeFrame: 18 months
measure: Change in Biochemical Markers of Bone Turnover (PINP)
timeFrame: 18 months
measure: Change in lipid profile
timeFrame: 18 months
measure: Change in vitamin D level
timeFrame: 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E DeBakey VA Medical Center
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Dennis T Villareal, MD
role: PRINCIPAL_INVESTIGATOR
References: