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 @ 3:03 AM
Ignite Modification Date:
2025-12-25 @ 3:03 AM
NCT ID:
NCT02068833
Eligibility Criteria:
Inclusion Criteria:
* Patient showing preoperative microalbuminuria (albumine/creatinine ratio between 2.0 and 20.0 in men and between 2.8 and 28.0 in women
* Men and Women between 18-60 years old;
* BMI ≥ 40 kg/m2 or between 35 and 40 kg/m2 if they have high-risk comorbidities;
* Subjects capable of understanding and being able to sign a consent form;
* Subjects capable of following the protocol directives, including the proposed visits (timeline);
* Subjects living within a reasonable distance from the hospital and capable of being present at all required visits.
Exclusion Criteria:
* Urinary infection;
* Hematuria (2+ or more) on 2 urinary analyses performed at 1 week interval;
* Hyperglycemia \> 11 mmol/L at the time of the 2 urinary analyses;
* Known renal disease unrelated to hypertension or diabetes, normoalbuminuria, macroalbuminuria or proteinuria;
* Pregnant women or women who plan on becoming pregnant during the study, or women in fertile age range who refuse proper contraceptive methods during the study. (Must have negative pregnancy test at moment of enrolment and use medically acceptable contraception which include; oral contraceptives, injectable or implantable contraceptives, intrauterine devices or double-barrier method ie. condoms and diaphragm);
* Previous oesophagal, gastric or bariatric surgery;
* Irritable bowel syndrome, unexplained intermittent vomiting, severe abdominal pain, diarrhea or chronic constipation;
* History of duodenal or gastric ulcers;
* History of renal disease, hepatic disease (cirrhosis) or severe cardiac or pulmonary disease;
* Corticosteroid intake in the previous month;
* Presence of psychiatric problems or behavioral issues that could limit subject's capacity at understanding the procedure and to conform to medical/surgical recommendations;
* History of drug use or alcoholism in previous 12 months before study;
* History of inflammatory diseases of the gastro-intestinal tract (Esophagitis, varices, gastric or duodenal ulcers, Crohn's disease, congenital or acquired anomalies of the digestive tract).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT02068833
Study Brief:
Protocol Section:
NCT02068833