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 @ 2:40 AM
Ignite Modification Date:
2025-12-25 @ 2:40 AM
NCT ID:
NCT01977833
Eligibility Criteria:
Inclusion Criteria:
1. Type 2 diabetes patients
2. HbA1C \> 7%
3. Duration of diabetes: 0.5 to 10 years
4. Subjects ≥ 30 and ≤70 years of age
5. BMI: 22 to 35 kg/m2
6. Diet controlled diabetic. Only treatment with metformin will be allowed
7. Normal liver and kidney function
8. Normal thyroid function
9. Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
10. Stable physical activity pattern during the three months immediately preceding study
11. Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
12. No shift work within 5 years of the study
13. Did not cross time zones within 1 month of the study
14. Read and understood the informed consent form and signed it voluntarily
Exclusion Criteria:
1. Type 1 diabetes
2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
3. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
4. Pregnancy or lactation
5. Illicit drug abuse or alcoholism
6. Treatment with antidiabetic drugs, insulin or GLP-1 analogs
7. Subjects taking anoretic drugs during the month immediately prior to study
8. Subjects on steroid treatment
9. Those with eating disorders
10. Subjects after bariatric surgery, will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
70 Years
Study:
NCT01977833
Study Brief:
Protocol Section:
NCT01977833