Thymus Regeneration, Immunorestoration, and Insulin Mitigation Extension Trial

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