Long-term Lifestyle Change and Testosterone Replacement

Aging Clinical Trial

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Official title:

Long-term Lifestyle Change in Obese Older Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256292
• Other study ID #: H-40598
• Status: Completed
• Start date: August 21, 2017
• Est. completion date: August 31, 2020

Study information

• Verified date: March 2021
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 (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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Aging
• Hypogonadism
• Overweight
• Overweight and Obesity

Intervention

Drug:
• Testosterone replacement
Testosterone replacement therapy

Behavioral:
• lifestyle
lifestyle intervention consisting of diet and increased physical activity

Locations

Country	Name	City	State
United States	Michael E DeBakey VA Medical Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 month
Primary	Change in body weight	Measured after an overnight fast using calibrated scales	18 month
Secondary	Change in body composition (lean mass, fat mass and bone mineral density)	Assessed by using dual-energy x-ray absorptiometry	18 month
Secondary	Volumetric BMD	Assessed by using peripheral quantitative computed tomography (pQCT)	18 month
Secondary	Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)	measured by ELISA	18 month
Secondary	Change in prostate specific antigen	measured in the blood	18 month
Secondary	Prostate Symptom Assessment	Using the International Prostate Symptom Scoring	18 month
Secondary	Mood	Using the Geriatric Depression Scale	18 month
Secondary	Quality of Life	Using SF-36 and impact of weight on quality of life short form (IWQOL-lite)	18 month
Secondary	Sexual function	Using the International Index of Erectile Function	18 month
Secondary	Change in trabecular bone score	Using DXA	18 month
Secondary	Change in muscle strength and quality	Using biodex dynamometry	18 month
Secondary	Change in balance	as measured by leg stance and obstacle course	18 month
Secondary	Change in Functional Status	Using functional status questionnaire	18 month
Secondary	Change in gait	as measured by completing the time to walk a certain distance	18 month
Secondary	Change in bone quality	Using HrpQCT	18 month
Secondary	Change in testosterone level	as measured in the blood	18 month
Secondary	Change in sex hormone globulin	as measured in the blood	18 month
Secondary	Change in metabolic hormones	Leptin, adiponectin, and similar metabolic hormones as measured in the blood	18 month
Secondary	Change in Composite cognitive z-score	using cognitive instrument testing	18 month
Secondary	Change in Modified mini-mental exam	using cognitive instrument testing	18 month
Secondary	Change in Stroop color naming	using cognitive instrument testing	18 month
Secondary	Change in Word list fluency	using cognitive instrument testing	18 month
Secondary	Change in Ray auditory verbal learning test	using cognitive instrument testing	18 month
Secondary	Change in Trail A/B	using cognitive instrument testing	18 month
Secondary	Change in waist circumference	as measured	18 month
Secondary	Change in serum PTH	as measured in the blood	18 month
Secondary	Change in lipid profile	as measured in the blood	18 month
Secondary	Change in blood pressure	as measured by sphygmomanometry	18 month
Secondary	Change in metabolic syndrome	using harmonized metabolic syndrome criteria	18 month
Secondary	bone strength index	assessed by pQCT	18 months
Secondary	Cortical to total area	assessed by pQCT	18 months
Secondary	Change in density weighted polar section modulus	assessed by pQCT	18 months
Secondary	Change in cortical density	assessed by pQCT	18 months
Secondary	Change in cortical area	assessed by pQCT	18 months
Secondary	Change in Biochemical Markers of Bone Turnover (PINP)	measured by RIA	18 months
Secondary	Change in lipid profile	measured in the blood	18 months
Secondary	Change in vitamin D level	measured in the blood	18 months