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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT03044860
Eligibility Criteria:
Inclusion criteria:
Type 2 diabetes patients
* Diagnosis of type 2 diabetes (at least 3 months prior to study inclusion)
* Treatment with diet counseling alone or combined with an glucose-lowering drugs: metformin or sulphonylurea
* Caucasian ethnicity
* Age \>25 and \<70 years
* Normal hemoglobin
* Negative for autoantibodies to glutamic acid decarboxylase (GAD-65) and islet cell autoantibodies (ICA).
Healthy individuals
* Fasting plasma glucose \<6.0 mM
* Plasma glucose 2 hours after a 75 g-oral glucose tolerance test \<7.8 mM
* Negative for GAD-65 antibodies and ICA
* Caucasian ethnicity
* Age \>25 and \<70 years
* Normal hemoglobin
Exclusion criteria:
Type 2 diabetes patients
* Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
* Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
* Previous hysterectomy, appendectomy, cholecystectomy or caesarean
* Sleep apnea
* American Society of Anesthesiologists class \>3
* Allergy to soy protein or eggs
* BMI \>35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy.
Healthy individuals
* Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
* Liver disease (evaluated by alanine aminotransferase and/or aspartate aminotransferase \>2 times normal value)
* Treatment with dipeptidyl peptidase 4 inhibitors or medicine that could not be paused for 12 hours
* Previous hysterectomy, appendectomy, cholecystectomy or caesarean
* Sleep apnea
* American Society of Anesthesiologists class \>3
* Allergy to soy protein or eggs
* BMI \>35 kg/m2 or any other condition that would contraindicate propofol sedation or enteroscopy
* First-degree relative(s) with type 1 or type 2 diabetes.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03044860
Study Brief:
Protocol Section:
NCT03044860