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 @ 2:19 AM
Ignite Modification Date:
2025-12-25 @ 2:19 AM
NCT ID:
NCT06236334
Eligibility Criteria:
Inclusion Criteria:
1. Healthy as assessed with screening questionnaire
2. HbA1c: 39 - 53 mmol/mol (= 5.7 - 7.0%)
3. Age between 18 - 70 years
4. Stable BMI of 25 - 35 kg/m2
5. Informed consent signed
6. Willing to comply with the study procedures during the study
7. Being able to become more physically active, as assessed by the screening questionnaire (P9885 F02; in Dutch).
8. Being digitally competent
9. Willing to accept the use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
Exclusion Criteria:
1. Being diagnosed with diabetes type 1 or 2
2. Use of insulin, corticosteroids (systemic), or beta-blockers in past month
3. Use of oral diabetes medication in past year
4. (Having a history of a) medical condition that might significantly affect the study outcome as judged by the general practitioner and health and lifestyle questionnaire. This includes gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder
5. Being abroad or on vacation for longer than a week.
6. Alcohol consumption \> 21 (women) - 28 (men) units/week
7. Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
8. Recent blood donation (\<1 month prior to the start of the study)
9. Not willing to give up blood donation during the study
10. Not willing to accept information-transfer concerning participation in the study, or information regarding his health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
11. Pregnant or lactating women
12. Involved in another Combined Lifestyle Intervention or weight loss program
13. On GLP-1 analogues to stimulate weight loss
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06236334
Study Brief:
Protocol Section:
NCT06236334