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 @ 3:48 AM
Ignite Modification Date:
2025-12-25 @ 3:48 AM
NCT ID:
NCT02854202
Eligibility Criteria:
Inclusion Criteria:
1. Participants: from 30 to 72 years of age
2. BMI: 26 to 34 kg/m2)
3. Diabetes criteria
4. HbA1C: 7-9 % or
5. Habitually eat breakfast
6. Only naïve or treated with metformin.
7. Not dieting and no change in body weight \>10 lb = 4.5 kg within the last 3 months
8. Normal liver, kidney and thyroid function.
Exclusion Criteria:
1. Type 1 Diabetes
2. Anemia (Hg \> 10 g/dL)
3. Serum creatinine level \< 1.5 mg/dl
4. Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
5. Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
6. Infectious disease
7. Pregnant women or lactating
8. Known hypersensitivity to milk components
9. Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
72 Years
Study:
NCT02854202
Study Brief:
Protocol Section:
NCT02854202