Reversal of epigenetic aging and immunosenescent trends in humans.
Gregory M Fahy, Robert T Brooke, James P Watson...
https://pubmed.ncbi.nlm.nih.gov/31496122Actively Recruiting
Phase 2
Age: 40Years - 80Years
All Genders
Healthy Volunteers
ID04375657
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
Led by Intervene Immune, Inc. · Updated on 2025-05-07
85
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized combination treatment to regenerate the thymus, an immune system organ that declines with age, in this expanded pilot clinical study called the TRIIM-X trial. The goal is to potentially prevent or reverse aspects of immune aging and other aging processes by studying biomarkers of epigenetic aging and immunosenescence. The study also monitors clinical measures and risk factors related to frailty, cancer, cardiovascular disease, diabetes, dementia, and infections like flu and COVID-19. The treatment involves personalized doses of recombinant human growth hormone (somatropin) combined with metformin and DHEA, similar to an earlier TRIIM trial that showed promising effects. Participants are assigned either to this combination treatment or an active control group receiving metformin and DHEA. The treatment lasts for 12 months, during which researchers evaluate the effects on thymus regeneration and aging biomarkers. Participants will be involved in a 12-month study with regular monitoring to assess epigenetic age, thymus regeneration, safety, tolerability, and immunosenescence. The study uses randomized assignment and single masking. Researchers will collect data on biomarkers and clinical outcomes, ensuring adherence and safety throughout. The trial aims to gather information to develop an effective personalized treatment for a broader population.
CONDITIONS
Brief Title
Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial
Who Can Participate
Age: 40Years - 80Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Male or female volunteers
- Aged 40 to 80 years, inclusive
- All ethnicities
- Able to participate in 12-month study
- Able to provide informed consent
You will not qualify if you...
- Malignancies or high risk of malignancy based on family or personal history
- Premenopausal women
- Postmenopausal women on hormone replacement therapy
- IGF-1 levels below 90 ng/ml or above 300 ng/ml
- Diagnosed or suspected growth hormone resistance
- Known growth hormone deficiency from testing
- Pre-existing carpal tunnel syndrome
- Significant arthritis, joint pain, or joint swelling
- Bradycardia (heart rate below 55 bpm)
- Significant hypertension despite treatment (systolic over 160 mmHg or diastolic over 90 mmHg)
- Serious angina or serious cardiovascular disease or risk factors
- Excessive skin growths without treatment options
- Body mass index of 35 or greater
- PSA level above age-adjusted normal except confirmed prostatitis
- Testosterone levels above normal limits
- Elevated C-reactive protein levels
- Type 1 or pre-existing Type 2 diabetes
- Uncorrected hypothyroidism
- HIV infection
- Allergy or sensitivity to study medications
- Other unstable medical conditions
- Use of growth hormone within last 5 years
- Participation in another clinical trial within 30 days
- Use of chronic glucocorticoid therapy
- Unwillingness to stop androgen supplements if testosterone is high
- Ongoing treatment with carbonic anhydrase inhibitors
- Following ketogenic, calorie-restricted diets, or prolonged fasting without willingness to stop or modify
- Alcoholism or drug addiction
- Smoking or unwillingness to quit smoking
- Cognitive impairment, illiteracy, or inability/unwillingness to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive personalized combinations of medications including somatropin, metformin, and DHEA, or metformin and DHEA as active control, to support thymus regeneration and immunorestoration.
Visits scheduled throughout the 12-month treatment period
Trial Site Locations
Total: 1 location
1
Intervene Immune
Torrance, California, United States, 90502
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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