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:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT03860558
Eligibility Criteria:
Inclusion Criteria:
* Male, age 18-65 years
* Willing and able to provide informed consent and follow all study procedures, including providing sperm specimens 3 months apart.
* Type 1 or type 2 diabetes diagnosis confirmed by an endocrinologist (for participants in the diabetes groups)
* HbA1c \> 7% (for participants in the diabetes groups)
* Overweight (BMI \> 25 kg/m2) (for all groups, to ensure groups are similar)
Exclusion Criteria:
* Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
* Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
* Severe diabetic retinopathy;
* Congestive heart failure, New York Heart Association (NYHA) class II, III or IV;
* History of myocardial infarction, unstable angina or revascularization within the past 6 months;
* Active genitourinary infection;
* Testicular volume \<12 mL (assessed using Prader orchidometer);
* Hypogonadism, defined as total testosterone \<250 ng/dl;
* Hyperprolactinemia, defined as prolactin \>18 ng/ml;
* Hyperestrogenism, defined as estradiol \>42 pg/ml;
* Cryptorchidism;
* Cigarette smoking;
* Active alcohol abuse or substance abuse;
* Cancer (except localized non-melanoma skin cancers) or use of chemotherapy agents within 5 years;
* Use of nitrates or guanylate cyclase stimulators;
* Use of steroid hormones (including testosterone), other than inhalers for reactive airway disease
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03860558
Study Brief:
Protocol Section:
NCT03860558