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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04186767
Eligibility Criteria:
Inclusion Criteria:
Obesity in male patients
* Metabolic Syndrome (NCEP-ATP III)
* Alteration of some of the seminal parameters evaluated in conventional seminal analysis
Exclusion Criteria:
* Other causes of hypogonadotrophic hypogonadism
* Hypergonadotrophic hypogonadism
* Contraindications for performance of ketogenic diet:
* Type 1 or type 2 diabetes mellitus in insulin use
* Food drive
* Alcoholism or drug addiction
* Severe psychiatric illness
* Use of coumarin anticoagulants
* Hepatic insufficiency
* Severe renal impairment
* Hematologic diseases
* Cancer in activity,
* Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke)
* Gout
* Renal or biliary lithiasis
* Major depression or other serious psychiatric illness.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04186767
Study Brief:
Protocol Section:
NCT04186767