Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

Inclusion criteria

• Male or female volunteers
• Aged 40 to 80 years, inclusive
• All ethnicities
• Able to participate in 12-month study
• Able to provide informed consent

Exclusion criteria

• Malignancies or high risk of malignancy, as suggested by familial risk or personal medical history
• Premenopausal women
• Postmenopausal women on HRT
• IGF-1 levels < 90 ng/ml or >300 ng/ml
• Diagnosed or suspected growth hormone resistance
• Known growth hormone deficiency based on stimulation testing
• Pre-existing carpal tunnel syndrome
• Significant arthritis/arthralgia/joint swelling
• Bradycardia (<55 bpm), significant hypertension (systolic >160 mmHg, or diastolic >90 mmHg) despite treatment, serious angina, or other serious cardiovascular disease or cardiovascular disease risk factors
• Excessive skin growths (e.g., flat warts) without cryosurgical options
• BMI of 35 or greater
• PSA level above the age-adjusted normal range for reasons other than confirmed prostatitis
• Testosterone levels above the upper limit of normal
• Levels of C-reactive protein (CRP) above the upper limit of normal
• Type 1 or pre-existing Type 2 diabetes
• Uncorrected hypothyroidism
• HIV infection
• Allergy or other sensitivity to study medications
• Other unstable medical conditions
• Use of GH within the last 5 years
• Participation in a clinical research trial within 30 days prior to enrollment
• Use of chronic glucocorticoid therapy
• Unwilling to discontinue androgen supplementation if testosterone levels are above the upper limit of normal
• Ongoing treatment with carbonic anhydrase inhibitors
• Ketogenic diet, calorie-restricted diet, or prolonged fasting, without willingness to discontinue these diets or adhere to an alternative diet during the study
• Alcoholism or drug addiction
• Smoking or unwillingness to quit smoking
• Cognitive impairment, illiteracy, inability or unwillingness to give voluntary informed consent