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 @ 1:06 PM
Ignite Modification Date:
2025-12-24 @ 1:06 PM
NCT ID:
NCT00835861
Eligibility Criteria:
Inclusion Criteria:
* Receiving prenatal care at University of North Carolina (UNC), Chapel Hill Obstetric clinics and planning delivery at UNC Women's Hospital
* Diagnosis of Diabetes prior to pregnancy with use of an oral hypoglycemic agent or dietary control
* Diagnosis of early gestational diabetes prior to 20 weeks gestation via abnormal 3 hour glucose challenge testing using the national diabetes data group (NDDG)criteria
* Less than 24 weeks at study enrollment
* Singleton or twin pregnancy
* English or Spanish speaking
* Able to give informed consent
Exclusion Criteria:
* End organ complications of diabetes (retinopathy, renal insufficiency, etc.)
* Prior need for insulin for glycemic control
* History of diabetic ketoacidosis (DKA) or hyperosmolar state
* Prior adverse reaction (ie. lactic acidosis) or allergy to Metformin
* Kidney or liver disease
* Significant medical co-morbidities (lupus, cystic fibrosis, etc.) Hypertension controlled on one medication, well controlled asthma, and well controlled thyroid disease are not excluded.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00835861
Study Brief:
Protocol Section:
NCT00835861