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 @ 9:23 PM
Ignite Modification Date:
2025-12-24 @ 9:23 PM
NCT ID:
NCT05263232
Eligibility Criteria:
Inclusion Criteria:
* Participants are able to provide signed and dates written consent prior to any study specific procedures
* Male + females (postmenopausal defined as at least 1 year post cessation of menses)
* T2DM duration at least 1 year
* BMI: ≥ 25 kg/m²
* Age: 40-75
* Well-controlled diabetes with respect to glycemic control and on stable anti-diabetes medication regimes
* Habitual bedtime of 23:00 ± 2h
* Regular sleep duration (7-9 h/night)
* Stable dietary habits: no weight gain or loss \> 5 kg in the last three months
Exclusion Criteria:
* Insulin treatment
* Uncontrolled hypertension
* Signs of active diabetes-related co-morbidities like active cardiovascular diseases, active diabetic foot, polyneuropathy or retinopathy
* Signs of active liver or kidney malfunction
* Use of SGLT2 inhibitors
* Using \> 400mg caffeine daily (more than 4 coffee or energy drink)
* Extreme early bird or extreme night person (score ≤30 or ≥70 on MEQ-SA questionnaire)
* shift work or travel across more than one time zone in the 3 months before the study
* Heavily varying sleep-wake rhythm
* Frequent engagement in programmed exercise as judged by the investigator
* Any medication that will interfere with the study outcomes or hamper the safety of the participant
* Alcohol consumption of \>2 servings per day for men and \>1 serving per day for woman
* Significant food allergies/intolerance (seriously hampering study meals)
* Subjects who do not want to be informed about unexpected medical findings during the screening /study, or do not wish that their physician is informed
* Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the Investigator
* Smoking in the past 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT05263232
Study Brief:
Protocol Section:
NCT05263232