Long-term Lifestyle Change and Testosterone Replacement (LITE)

Long-term Lifestyle Change in Obese Older Veterans

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.

Study Overview

• Status: Completed
• Conditions: Aging; Hypogonadism; Overweight and Obesity
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Michael E DeBakey VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 85 years (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in body weight	Measured after an overnight fast using calibrated scales	18 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Baylor College of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 21, 2017
• Primary Completion (ACTUAL): August 31, 2020
• Study Completion (ACTUAL): August 31, 2020

Study Registration Dates

• First Submitted: August 16, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (ACTUAL): August 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Body Weight; Overweight; Hypogonadism; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Androgens; Testosterone
• Other Study ID Numbers: H-40598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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