Lifestyle Intervention and Testosterone Replacement in Obese Seniors
LITROS
Testosterone Replacement to Augment Lifestyle Therapy in Obese Older Veterans
2 other identifiers
interventional
83
1 country
1
Brief Summary
The prevalence of obesity in Veterans is greater than in the general population, and even more so among users of the VA Health Care System. In addition, the population of obese older Veterans is rapidly increasing as more baby boomers become senior citizens. In older Veterans, obesity exacerbates the age- related decline in physical function and causes frailty which predisposes to admission to a VA chronic care facility. However, the optimal clinical approach to obesity in older adults is controversial because of the concern that weight loss therapy could be harmful by aggravating the age-related loss of muscle mass and bone mass. In fact, the MOVE (Managing Overweight/Obese Veterans) program does not have any guidelines for eligible Veterans if they are 70 or older. It is possible that the addition of testosterone replacement to lifestyle therapy will preserve muscle mass and bone mass and reverse frailty in obese older Veterans and thus prevent their loss of independence and decrease demand for VA health care services.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Feb 2015
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2015
CompletedStudy Start
First participant enrolled
February 1, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedResults Posted
Study results publicly available
August 31, 2020
CompletedJuly 26, 2022
January 1, 2022
4.5 years
January 21, 2015
July 22, 2020
July 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the Physical Performance Test
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. Higher scores indicate better physical function.
Baseline and 6 months
Secondary Outcomes (30)
Change in Endurance Capacity
Baseline and 6 months
Change in Functional Status
Baseline and 6 months
Change in Body Weight
Baseline and 6 months
Change in Lean Body Mass
Baseline and 6 months
Change in Fat Mass
Baseline and 6 months
- +25 more secondary outcomes
Other Outcomes (14)
Change in Total Testosterone Levels
Baseline and 6 months
Change in Estradiol
Baseline and 6 months
Change in Hematocrit
Baseline and 6 months
- +11 more other outcomes
Study Arms (2)
Testosterone plus Lifestyle Therapy
ACTIVE COMPARATORTestosterone replacement in combination with behavioral diet to induce \~10% weight loss + supervised aerobic and exercise training
Placebo plus Lifestyle Therapy
PLACEBO COMPARATORPlacebo in combination with behavioral diet to induce \~10% weight loss and supervised aerobic and exercise training
Interventions
Daily testosterone gel applied once daily in the morning to intact skin
Weekly behavioral diet to induce \~10% weight loss in combination with supervised aerobic and exercise training three times a week
Eligibility Criteria
You may qualify if:
- Subjects will be
- older (65-85 yr)
- obese (BMI 30 kg/m2 or greater) Veteran men with low testosterone (less than 300 mg/dL) as defined by the Endocrine Society
- mild to moderately frail
- must have stable weight (\~not less than or more than 2 kg) during the last 6 months
- sedentary (regular exercise less than 1 h/week or less than 2x/week for the last 6 months)
You may not qualify if:
- Any major chronic diseases, or any condition that would interfere with exercise or dietary restriction, in which exercise or dietary restriction are contraindicated, or that would interfere with interpretation of results.
- Examples include, but are not limited to:
- cardiopulmonary disease (e.g. recent myocardial infarction (MI), unstable angina, stroke etc) or unstable disease (e.g. CHF)
- severe orthopedic/musculoskeletal or neuromuscular impairments
- visual or hearing impairments
- cognitive impairment (Mini Mental State Exam Score less than 24)
- current use of bone active drugs
- uncontrolled diabetes (i.e. fasting blood glucose more than 140 mg/dl and/or HbA1c greater than 9.5%).
- Any contraindications to testosterone supplementation
- history of prostate or breast cancer
- history of testicular disease
- untreated sleep apnea
- hematocrit more than 50%
- prostate-related findings of palpable nodule on exam, a serum PSA of 4.0 ng/ml or greater
- International Prostate Symptom Sore more than 19
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VA Office of Research and Developmentlead
- Michael E. DeBakey VA Medical Centercollaborator
- Baylor College of Medicinecollaborator
- Biomedical Research Institute of New Mexicocollaborator
Study Sites (1)
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030, United States
Related Publications (1)
Gregori G, Celli A, Barnouin Y, Paudyal A, Armamento-Villareal R, Napoli N, Qualls C, Villareal DT. Cognitive response to testosterone replacement added to intensive lifestyle intervention in older men with obesity and hypogonadism: prespecified secondary analyses of a randomized clinical trial. Am J Clin Nutr. 2021 Nov 8;114(5):1590-1599. doi: 10.1093/ajcn/nqab253.
PMID: 34375393DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dennis T Villareal, MD
- Organization
- Michael E DeBakey VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Dennis T Villareal, MD
Michael E. DeBakey VA Medical Center, Houston, TX
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
February 20, 2015
Study Start
February 1, 2015
Primary Completion
July 31, 2019
Study Completion
December 31, 2019
Last Updated
July 26, 2022
Results First Posted
August 31, 2020
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share
Publications from this research will be made available to the public through the National Library of Medicine PubMed Central website within one year after the date of publication (guidance is provided on the ORD website). MEDVAMC will not provide unrestricted, open public access to large scale health related datasets because of re-identification concerns and the obligation to protect Veterans' private information. However, controlled public access 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 (aggregated data that can be released with privacy and confidentiality risks).