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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT02196350
Eligibility Criteria:
Inclusion Criteria:
1. Healthy as assessed by the
* health and lifestyle questionnaire, (P9607 F02; in Dutch)
* physical examination
* results of the pre-study laboratory tests
2. Age 30-80 years
3. Stable BMI 25-35 kg/m2
4. Diagnosis diabetes type 2 based upon:
Fasting glucose \>6.9 mmol/l on two different days or one measurement of non-fasting glucose \>11.0 mmol/l in combination with symptoms of hyperglycemia
5. Duration of diabetes maximally 1 year
6. Informed consent signed;
7. Willing to comply with the study procedures during the study;
8. Appropriate veins for blood sampling/ cannula insertion according to the general practitioner assistant (GPA);
9. Voluntary participation
10. Physically able to perform training activities
11. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.
Exclusion Criteria:
1. Use of insulin, corticosteroids (systemic), or beta-blockers in past month
2. Diabetes occurring after several attacks of pancreatitis known as pancreatic diabetes
3. Slow onset type 1 diabetes
4. Use of oral diabetes medication in past year
5. (Having a history of a) medical condition that might significantly affect the study outcome as judged by the medical investigator and health and life style questionnaire. This includes diabetes type 1, gastrointestinal dysfunction, diseases related to inflammation or allergy, or a psychiatric disorder.
6. Hypertension: systolic blood pressure \>160 mmHg, diastolic blood pressure \>90 mmHg
7. Kidney problems based upon proteinuria and creatinine \>150 mmol/l
8. Insufficient beta cell function based on Disposition index \< 1.5 as determined during the OGTT in study on day 01\*
9. Physical activity higher than according to the Diabetes guidelines (moderate intensity one hour a day, seven days a week (overweight adults))
10. Alcohol consumption \> 21 (women) - 28 (men) units/week
11. Reported unexplained weight loss or gain of \> 2 kg in the month prior to the pre-study screening
12. Recent blood donation (\<1 month prior to the start of the study)
13. Not willing to give up blood donation during the study
14. Personnel of TNO and their partner
15. Not having a general practitioner
16. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT02196350
Study Brief:
Protocol Section:
NCT02196350