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 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT07075133
Eligibility Criteria:
Inclusion Criteria:
* Post-menopausal women (amenorrhea for at least 12 months, confirmed by gonadotrophins measures)
* Age range 45-70 years
* T2DM diagnosed for more than 1 year
* Subjects with T2DM treated with lifestyle control alone or associated with metformine ± DPP4 inhibitors
* Ability to sign written informed consent before any study-specific procedure
* Subject considered as reliable and capable of adhering to protocol
* Subjects with Body Mass Index (BMI)≥ 30 kg/m²
* Baseline eating period ≥ 14 h per day (as estimated by 95% eating interval)
Exclusion Criteria:
* Subjects on T2DM injectable medication or drugs able to induce hypoglycemia (glinides, sulfonylurea)
* Subjects with HbA1c \> 8%
* Subjects with any of the following medical conditions:
* Congestive cardiac failure
* Stage 4 chronic kidney disease (i.e. eGFR \< 30 ml/min/1.73 m2)
* Liver cirrhosis or chronic liver disease
* Any medical condition that in the opinion of the investigator could jeopardize or compromise the subject's ability to participate in the study
* Subjects with previous or present history of serious eating disorder
* Subjects not able to understand the informed consent form or fasting diary instructions
* Subjects currently participating or has participated in another study of an investigational medication or an investigational medical device within the last 30 days
* Women with menopause hormone replacement therapy
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT07075133
Study Brief:
Protocol Section:
NCT07075133