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 @ 5:48 PM
Ignite Modification Date:
2025-12-24 @ 5:48 PM
NCT ID:
NCT05073068
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Healthy (determined by dependent physician)
* Man or post-menopausal woman
* Age between 50 - 75 years
* BMI ≥ 25 kg/m2
* Pre-diabetes based on meeting at least one of the following criteria: impaired glucose tolerance defined as plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after glucose drink consumption during oral glucose tolerance test in screening, impaired fasting glucose defined as fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l, insulin resistance defined as a glucose clearance rate ≤ 360 mL/kg/min as determined using OGIS120, HbA1c of 5.7-6.4%
* Regular sleeping habits (7 - 9h of daily sleep)
* Stable diet and weight: No weight gain or loss \> 3kg in the last three months
Exclusion Criteria:
* Not meeting all inclusion criteria
* Fasting plasma glucose
* ≥ 7.0 mmol/L
* Hemoglobin \< 7.8 mmol/L
* Previously diagnosed with type 2 diabetes
* Uncontrolled hypertension
* In case of an abnormal electrocardiogram at rest: this will be discussed with the responsible medical doctor
* 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
* Any contra-indication to the Equivital telemetric pill
* Hypomotility disorders of the gastro-intestinal tract
* Extreme early bird or extreme night person (score ≤30 or ≥70 on morning-eveningness questionnaire self assessment)
* Heavily varying sleep-wake rhythm
* Night shift work during last 3 months
* Travel across \> 1 time zone in the last 3 months
* Frequent engagement in programmed exercise as judged by the investigator
* Significant food allergies/intolerance (seriously hampering study meals)
* Participation in another biomedical study within 1 month before the first study visit
* Using \> 400mg caffeine daily (more than 4 cups of coffee or energy drinks)
* Smoking
* Any acute condition, exacerbation of chronic condition, or medical history that would in the investigator's opinion interfere with the study
* Antecubital veins that present tremendous difficulty in obtaining frequent blood draws (e.g. too small)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT05073068
Study Brief:
Protocol Section:
NCT05073068