Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT04375657
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04375657
Study Brief:
Protocol Section:
NCT04375657