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 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
NCT ID:
NCT05294861
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with T2D \< 20 years
* HbA1c ≥ 6.5 %.
* BMI - 28-45 kg/m2
* Men and women 30 -75 years of age inclusive
* Normal liver, kidney, and thyroid functions, and eGFR \> 45 mL/min/1.73 m2.
* Type 2 diabetes controlled with diet, lifestyle alone, or with antidiabetics other than insulin (i.e. biguanides, sulfonylureas, glinides, SGLT2 inhibitors, DPP4 inhibitors, GLP-1 analogs), with stable doses for at least 3 months before entering the study.
* Stable weight (less than 5% change in body weight in last 3 months before the study - determined by self-reporting or documentation in clinical records).
* Concomitant medication i.e. antihypertensive, anti-lipidemic, anti-thrombotic drugs will be allowed also on a stable dose for at least 3 months before the beginning of the trial.
* Patients that usually wake up between 06:00 and 08:00 and go to sleep between 22:00 and 24:00.
* Should not have shift work within 6 months of the study and should not have crossed time zones within 2 weeks of the study.
* No change in medication or nutrition supplements or physical activity will be made during the study.
Exclusion Criteria:
* Type 1 diabetes or secondary forms of diabetes.
* Patients with latent autoimmune diabetes in adults (LADA).
* Treatment with insulin.
* Serum creatinine level \>2mg/dl. Renal dysfunction: eGFR \< 45 mL/min/1.73 m2).
* Hepatic dysfunction: liver disease or transaminase levels \> 2.5-fold above normal.
* Major illness with life expectancy \< 5 years.
* Malignant neoplasm requiring chemotherapy, surgery, radiation, or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer).
* Those taking psychotropic, anorectic medication, steroid treatment, or illicit drug abuse or alcoholism within one year prior to study onset. Pregnancy or lactation.
* Known hypersensitivity to milk components or lactose intolerance.
* Night or rotating shift workers or those who crossed more than 2 time zones during the 2- week period prior to study onset.
* Not able to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
75 Years
Study:
NCT05294861
Study Brief:
Protocol Section:
NCT05294861