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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04093856
Eligibility Criteria:
Inclusion Criteria:
A) Diabetic group
* BMI \>=35 kg/m2
* Clinical diagnosis of type 2 diabetes
* Use of oral hypoglycemic agents or insulin or 2 of the following tests confirming type 2 diabetes: HbA1c \>=6.5%; fasting glucose \>=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) \>=11.1 mM)
B) Non-diabetic group:
* BMI \>=35 kg/m2
* Normoglycemia (HgbA1c \<5.7% and Fasting glucose \<5.6 nM)
Exclusion Criteria:
* BMI \>60 kg/m2
* Clinical diagnosis of type 1 diabetes
* Disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \<60 ml/min)
* Medication (e.g. gluccocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism
* Pregnancy
* History of oesophageal, gastric, digestive or bariatric surgery
* Prosthesis that could interfere with interpretation of imaging data
* Chronic severe condition or illness precluding from participation in the project.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04093856
Study Brief:
Protocol Section:
NCT04093856