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 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT03821220
Eligibility Criteria:
Inclusion Criteria:
Pre-diabetes patients - Impaired fasting glucose at least twice between 100-125 mg/dL in the two years prior to the study; or HbA1C 5.7%-6.4% twice in the two years prior to the study; or one test of fasting glucose of 100-125 mg/dL, and one test of HbA1C between 5.7%-6.4% in the two years prior to the study.
Exclusion Criteria:
1. Diabetes including a doctor's diagnosis based on a medical file or a recurrence of fasting blood glucose values above 126 mg/dL in the year preceding the study or a glucose value greater than 200 mg/dL in the year prior to the study or HbA1C above 6.5%
2. Treatment with diabetes drugs other than metformin, as prescribed in the medical file with regular or chronic medications
3. Artificial lower limbs or inability to walk normally (eg: stroke with plegia)
4. Chronic obstructive pulmonary disease
5. Known heart disease (with impaired exercise tolerance)
6. Pregnancy
7. Medical conditions:
* a cardiac event/ Transient ischemic attack in the last year
* Cerebrovascular attack with residual impairment
* Surgery that required hospitalization in the last year
* Injury to lower limbs that prevents regular walking
* Malignancy excluding skin cancer small cell carcinoma or basal cell carcinoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT03821220
Study Brief:
Protocol Section:
NCT03821220