Muscle Anabolic Interventions to Accelerate Recovery From Hospitalization in Geriatric Patients

NCT02990533 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 16-0146
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot study is to collect preliminary data on the feasibility and effect size of interventions to modify the physiological recovery trajectory from hospitalization in community dwelling older adults.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• Physical Performance

  Short Physical Performance Battery (SPPB) scale, 0-12 points. 0=disabled; 12=high performance

  Change from Baseline to 30-day Followup

Secondary Outcomes (3)

• Handgrip Strength

  Change from Baseline to 30-day Followup

• Physical Activity Level

  Change from Baseline to 30-day Followup

• 30 day re-admission

  30 days post-discharge

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Placebo Supplement Placebo Injection

Other: Placebo Injection; Other: Placebo supplement

Testosterone

EXPERIMENTAL

Placebo Supplement Testosterone Injection

Drug: Testosterone; Other: Placebo supplement

Protein Supplement

EXPERIMENTAL

Protein Supplement Placebo Injection

Dietary Supplement: Protein Supplement; Other: Placebo Injection

Protein Supplement + Testosterone

EXPERIMENTAL

Protein Supplement Testosterone Injection

Drug: Testosterone; Dietary Supplement: Protein Supplement

Interventions

Testosterone DRUG

Also known as: testosterone enanthate

Protein Supplement + Testosterone; Testosterone

Protein Supplement DIETARY_SUPPLEMENT

Also known as: whey protein

Protein Supplement; Protein Supplement + Testosterone

Placebo Injection OTHER

Also known as: saline

Placebo; Protein Supplement

Placebo supplement OTHER

Also known as: maltodextrin

Placebo; Testosterone

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Admitted to the UTMB hospital
• Aged 65 years or older
• Self-reported ability (with or without the aid of an assistive device) to walk across a small room two weeks prior to hospitalization
• Alert and oriented x3 by a physician on H\&P.
• Discharged "to home" at hospital discharge. Participation in the study will be terminated in those subjects not discharged to home after hospital stay.

You may not qualify if:

• A Nursing home resident or hospice care patient
• Uncontrolled blood pressure (systolic \>170, or diastolic \> 100)
• New onset motor disability that prevents walking at the time of baseline testing (stroke with motor disability, lower limb orthopedic dx)
• End stage renal disease
• AST/ALT 2.5 times above the normal limit
• Recent (within 3 months) or current treatment with anabolic steroids.
• History of breast or prostate cancer
• Palpable prostate nodule or induration or prostate specific antigen (PSA) ≥ 4 ng/ml (PSA ≥ 3 ng/ml in men at high risk of prostate cancer)
• Hematocrit ≥ 50%

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

Jennie Sealy Hospital

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Arentson-Lantz EJ, Boyle JT, Deer RR, Kokonda M, Bennetsen D, Carreon SA, Meers JM, Taffet G, Vahidy FS, Agarwal KS, Volpi E, Nowakowski S. Association of Sleep Disturbance and Physical Functioning Following Acute Hospitalisation in Older Adults. J Sleep Res. 2025 Nov 29:e70252. doi: 10.1111/jsr.70252. Online ahead of print.

  PMID: 41316872 DERIVED

MeSH Terms

Interventions

Testosterone; testosterone enanthate; Whey Proteins; Sodium Chloride; maltodextrin

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Elena Volpi, MD, PhD

  UTMB

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2016
• First Posted: December 13, 2016
• Study Start: September 1, 2016
• Primary Completion: November 8, 2020
• Study Completion: November 8, 2020
• Last Updated: December 17, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)