Long-term Lifestyle Change and Testosterone Replacement

NCT03256292 | Completed DMC FDA Drug

• 1 other identifier: H-40598
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypogonadism; Aging; Overweight and Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (36)

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

  18 month

• Volumetric BMD

  18 month

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

  18 month

• Change in prostate specific antigen

  18 month

• Prostate Symptom Assessment

  18 month

Study Arms (1)

testosterone, diet, and increased physical activity

Group receiving standard of care consisting of diet and regular exercise counseling + testosterone replacement therapy

Drug: Testosterone replacement; Behavioral: lifestyle

Interventions

Testosterone replacement DRUG

Testosterone replacement therapy

testosterone, diet, and increased physical activity

lifestyle BEHAVIORAL

lifestyle intervention consisting of diet and increased physical activity

testosterone, diet, and increased physical activity

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Michael E DeBakey VA Medical Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Hypogonadism; Overweight; Obesity

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis T Villareal, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 22, 2017
• Study Start: August 21, 2017
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)