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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT06739993
Eligibility Criteria:
Inclusion Criteria:
* Presence of prediabetes Fasting glucose: 100-125 mg/dl (5.6-6.9 mmol/L) and/or HbA1c in %: 5.7-6.4 (39-47 mmol/mol Hb) and/or 2-hour value of the 75 g OGTT: 140-199 mg/dl (7.8-11.0 mmol/L)
* This is checked using a 75 g OGTT in a screening visit.
* Age between 18 and 65 years
* BMI between 20 and 40 kg/m²
Exclusion Criteria:
* Diabetes mellitus
* Malignant diseases within the last 5 years before randomization
* History of gastrointestinal surgery
* Pancreatic diseases other than pancreatic lipomatosis
* Acute diseases or infections
* Regular intake of cardiac drugs that affect heart rate within the last 4 weeks before the first measurement (e.g. beta-receptor blockers, antiarrhythmics, etc.)
* Intake of centrally acting drugs
* Medical contraindications to a meaningful interpretation of the heart rate analysis (e.g. patients with pacemakers, atrial fibrillation or other arrhythmias)
* Chronic diseases (particularly metabolic diseases, heart diseases, blood diseases)
* Endocrinological disease other than substituted hypothyroidism
* Mental illnesses
* Intake of drugs that can affect blood sugar metabolism (e.g. steroids)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06739993
Study Brief:
Protocol Section:
NCT06739993