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Long-term Lifestyle Change and Testosterone Replacement (LITE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03256292
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : March 10, 2021
Sponsor:
Information provided by (Responsible Party):
Dennis T. Villareal, Baylor College of Medicine

Study Description
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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.

Condition or disease Intervention/treatment
Hypogonadism Aging Overweight and Obesity Drug: Testosterone replacement Behavioral: lifestyle

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.

Study Design
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Study Type : Observational
Actual Enrollment : 38 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Long-term Lifestyle Change in Obese Older Veterans
Actual Study Start Date : August 21, 2017
Actual Primary Completion Date : August 31, 2020
Actual Study Completion Date : August 31, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
testosterone, diet, and increased physical activity
Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy
 Drug: Testosterone replacement
Testosterone replacement therapy

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03256292


Locations
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United States, Texas
Michael E DeBakey VA Medical Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Dennis T Villareal, MD Baylor College of Medicine
More Information
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Responsible Party: Dennis T. Villareal, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03256292    
Other Study ID Numbers: H-40598
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A De-identified, Anonymized Dataset will be created and shared. NOTE: ORO recommends that such sharing take place under a written agreement that adheres to any applicable Informed Consent provisions and prohibits the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.
Supporting Materials: Study Protocol
Time Frame: Controlled access requests will be provided to the greatest extent possible under specific DUAs or other written agreements and open access will be provided to the final datasets underlying peer-reviewed publications in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.
Access Criteria: Controlled access requests will be provided to the greatest extent possible under specific DUAs or other written agreements and open access will be provided to the final datasets underlying peer-reviewed publications in accordance with the research disposition policy which states that research records will be destroyed 6 years after cutoff (at the end of the fiscal year) after completion of the research project, but may be retained longer if required by other federal regulations or sponsor archive requirements.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Overweight
Hypogonadism
Overnutrition
Nutrition Disorders
Body Weight
Gonadal Disorders
 Endocrine System Diseases
Testosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs