Long-term Lifestyle Change in Obese Older Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
testosterone, diet, and increased physical activity
Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy
干预措施: Testosterone replacement (Drug)
testosterone, diet, and increased physical activity
Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy
干预措施: lifestyle (Behavioral)
结局指标
主要结局
Change in body weight
时间窗: 18 month
Measured after an overnight fast using calibrated scales
Change in Physical Performance Test score
时间窗: 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.
次要结局
- Change in vitamin D level(18 months)
- Quality of Life(18 month)
- Change in prostate specific antigen(18 month)
- Mood(18 month)
- Change in Modified mini-mental exam(18 month)
- Change in testosterone level(18 month)
- Change in Composite cognitive z-score(18 month)
- Change in waist circumference(18 month)
- Change in blood pressure(18 month)
- Volumetric BMD(18 month)
- Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)(18 month)
- Change in sex hormone globulin(18 month)
- Change in metabolic hormones(18 month)
- Change in Ray auditory verbal learning test(18 month)
- Change in Trail A/B(18 month)
- Change in metabolic syndrome(18 month)
- bone strength index(18 months)
- Change in density weighted polar section modulus(18 months)
- Change in cortical density(18 months)
- Change in cortical area(18 months)
- Prostate Symptom Assessment(18 month)
- Change in body composition (lean mass, fat mass and bone mineral density)(18 month)
- Sexual function(18 month)
- Change in muscle strength and quality(18 month)
- Change in balance(18 month)
- Change in Functional Status(18 month)
- Change in gait(18 month)
- Change in bone quality(18 month)
- Change in Stroop color naming(18 month)
- Change in serum PTH(18 month)
- Change in trabecular bone score(18 month)
- Change in Word list fluency(18 month)
- Change in lipid profile(18 months)
- Cortical to total area(18 months)
- Change in Biochemical Markers of Bone Turnover (PINP)(18 months)
研究者
Dennis T. Villareal
Professor
Baylor College of Medicine