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 @ 12:24 PM
Ignite Modification Date:
2025-12-24 @ 12:24 PM
NCT ID:
NCT04304261
Eligibility Criteria:
Inclusion Criteria:
* Newly onset type 2 diabetes within 3 months
* 7%\<HbA1c\<10%
Exclusion Criteria:
* Type 2 diabetes with acute diabetic complications.
* Type1 diabetes.
* Thyroid dysfuncition.
* Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.
* History of cardio-cerebral vascular events, such as congestive heart failure, myocardial infarction or stroke within 3 months.
* Hepatic insufficiency (AST or AST is twice higher than the upper limit) or history of hepatitis or cirrhosis, hepatic encephalopathy.
* Renal insufficiency (serum creatinine 1.5 times higher than the upper limit) or history of dialysis and nephritic syndrome.
* Acute infections, tumor, severe arrhythmia.
* Alcohol or medicine addiction, psychoactive substance abuse.
* Other diseases affecting cognitive function (congenital dementia, brain trauma, parkinson's diseases, toxicencephacopathy,epilepsy, mental disorders, severe lungdy sfunction, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, etc.)
* Fertile woman without contraceptives.
* Allergic to or have contraindication to the intervention drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04304261
Study Brief:
Protocol Section:
NCT04304261