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Completed

NCT Number: NCT03256292

Long-term Lifestyle Change and Testosterone Replacement

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.

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Key information

Conditions

Hypogonadism Aging Body Weight Endocrine System Diseases Gonadal Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year–85 year

Sex eligibility

Male

Study type

Observational

Primary location

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Testosterone replacement

Drug

Testosterone replacement therapy

Lifestyle

Behavioral

lifestyle intervention consisting of diet and increased physical activity

Primary outcomes

  1. Change in Physical Performance Test score

    Time frame: 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.

  2. Change in body weight

    Time frame: 18 month

    Measured after an overnight fast using calibrated scales

Secondary outcomes

  1. Change in body composition (lean mass, fat mass and bone mineral density)

    Time frame: 18 month

    Assessed by using dual-energy x-ray absorptiometry

  2. Volumetric BMD

    Time frame: 18 month

    Assessed by using peripheral quantitative computed tomography (pQCT)

  3. Biochemical Markers of Bone Turnover (Serum C-terminal telopeptide (CTX)

    Time frame: 18 month

    measured by ELISA

  4. Change in prostate specific antigen

    Time frame: 18 month

    measured in the blood

  5. Prostate Symptom Assessment

    Time frame: 18 month

    Using the International Prostate Symptom Scoring

  6. Mood

    Time frame: 18 month

    Using the Geriatric Depression Scale

  7. Quality of Life

    Time frame: 18 month

    Using SF-36 and impact of weight on quality of life short form (IWQOL-lite)

  8. Sexual function

    Time frame: 18 month

    Using the International Index of Erectile Function

  9. Change in trabecular bone score

    Time frame: 18 month

    Using DXA

  10. Change in muscle strength and quality

    Time frame: 18 month

    Using biodex dynamometry

  11. Change in balance

    Time frame: 18 month

    as measured by leg stance and obstacle course

  12. Change in Functional Status

    Time frame: 18 month

    Using functional status questionnaire

  13. Change in gait

    Time frame: 18 month

    as measured by completing the time to walk a certain distance

  14. Change in bone quality

    Time frame: 18 month

    Using HrpQCT

  15. Change in testosterone level

    Time frame: 18 month

    as measured in the blood

  16. Change in sex hormone globulin

    Time frame: 18 month

    as measured in the blood

  17. Change in metabolic hormones

    Time frame: 18 month

    Leptin, adiponectin, and similar metabolic hormones as measured in the blood

  18. Change in Composite cognitive z-score

    Time frame: 18 month

    using cognitive instrument testing

  19. Change in Modified mini-mental exam

    Time frame: 18 month

    using cognitive instrument testing

  20. Change in Stroop color naming

    Time frame: 18 month

    using cognitive instrument testing

  21. Change in Word list fluency

    Time frame: 18 month

    using cognitive instrument testing

  22. Change in Ray auditory verbal learning test

    Time frame: 18 month

    using cognitive instrument testing

  23. Change in Trail A/B

    Time frame: 18 month

    using cognitive instrument testing

  24. Change in waist circumference

    Time frame: 18 month

    as measured

  25. Change in serum PTH

    Time frame: 18 month

    as measured in the blood

  26. Change in lipid profile

    Time frame: 18 month

    as measured in the blood

  27. Change in blood pressure

    Time frame: 18 month

    as measured by sphygmomanometry

  28. Change in metabolic syndrome

    Time frame: 18 month

    using harmonized metabolic syndrome criteria

  29. bone strength index

    Time frame: 18 months

    assessed by pQCT

  30. Cortical to total area

    Time frame: 18 months

    assessed by pQCT

  31. Change in density weighted polar section modulus

    Time frame: 18 months

    assessed by pQCT

  32. Change in cortical density

    Time frame: 18 months

    assessed by pQCT

  33. Change in cortical area

    Time frame: 18 months

    assessed by pQCT

  34. Change in Biochemical Markers of Bone Turnover (PINP)

    Time frame: 18 months

    measured by RIA

  35. Change in lipid profile

    Time frame: 18 months

    measured in the blood

  36. Change in vitamin D level

    Time frame: 18 months

    measured in the blood

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Registry information

Official study title

Long-term Lifestyle Change in Obese Older Veterans

Acronym: LITE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2017
Registry last updated
Mar 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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