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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT05303857
Eligibility Criteria:
Inclusion Criteria:
* Age of 18 - 75 years
* Diagnosis of type 2 diabetes mellitus: defined by fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6,5 % or on oral single or dual blood glucose lowering medication (held constant for the last 3 months)
* HbA1c ≥ 7.0%
* Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
* Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
* Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form
Exclusion Criteria:
* Any other form of diabetes mellitus than type 2 diabetes mellitus
* Use of insulin, sulfonylurea or GLP-1 analogue within the past 3 months
* Patients with more than two oral blood glucose lowering medication
* HbA1c ≥ 10.5%
* Body mass index \> 40 kg/m²
* Fasting plasma glucose \> 240 mg/dl
* Any form of diabetic retinopathy, macular oedema
* Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m²
* Acute or chronic pancreatitis
* Uncontrolled arterial hypertension (BP ≥ 180/110 mmHg)
* Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 3 months prior to study inclusion
* Congestive heart failure (CHF) NYHA stage III and IV
* Drug or alcohol abuses
* Pregnant or breast-feeding patients
Subset of patients receiving ASL-MRI, exclusion criteria-
Patients with contraindications to MRI, including:
* Brain aneurysm clip
* Implanted neural stimulator
* Implanted cardiac pacemaker or defibrillator, or presence of intracardiac wires
* Prosthetic heart valves
* Cochlear implant
* Ocular foreign bodies that might be ferromagnetic (e.g., metal shavings)
* Other implanted medical devices (e.g., insulin pumps)
* Metal shrapnel or bullets still in the body
* Severe claustrophobia
* Tattoos (as determined by the Investigator and Imager)
* Weight in excess of MRI machine capacity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05303857
Study Brief:
Protocol Section:
NCT05303857