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 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT02338193
Eligibility Criteria:
Inclusion Criteria:
* • Overweight/obese (BMI \>25) females 18 years to 45 years of age, who experienced gestational diabetes (GDM) during recent (within 12 months) pregnancy
* postpartum metabolic abnormalities determined by a 75 g oral glucose tolerance test (Inclusive of prior GDM women with impaired fasting glucose (IFG), impaired glucose tolerance (IGT), or both (IFG/IGT) postpartum)
* Completed lactation
* Using adequate contraception during study period unless sterilized
* Written consent for participation in the study
Exclusion Criteria:
* Cholestasis during the past pregnancy
* Any hepatic diseases in the past (viral hepatitis, toxic hepatic damage, jaundice of unknown etiology), gallstones, abnormal liver function tests or renal impairment (elevated serum creatinine levels or abnormal creatinine clearance
* Presence of significant systemic disease, heart problems including congestive heart failure, history of pancreatitis, or diabetes mellitus (Type 1 or 2)
* Renal impairment (e.g., serum creatinine levels ≥1.4 mg/dL for women, or eGFR \<60)
* Significantly elevated triglyceride levels (fasting triglyceride \> 400 mg %)
* Untreated or poorly controlled hypertension (sitting blood pressure \>160/95mm Hg)
* Prior history of a malignant disease requiring chemotherapy
* Known hypersensitivity or contraindications to use of insulin sensitizers such as metformin or thiazolidinediones
* History of hypersensitivity reaction to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions)
* Current use of metformin, thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT2 inhibitors or weight loss medications (prescription or OTC)
* Uncontrolled thyroid disease (documented normal TSH) or hyperprolactinemia
* Liver enzymes (serum alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] ) levels exceeding more than twice normal lab values
* Use of drugs known to exacerbate glucose tolerance
* History of diabetes or prior use of medications to treat diabetes except GDM
* Currently lactating
* Eating disorders (anorexia, bulimia) or gastrointestinal disorders
* Suspected pregnancy (documented negative serum pregnancy test within 72 hours before first dose of study drug), desiring pregnancy in next 6 months, breastfeeding, or known pregnancy in last 2 months
* Active or prior history of substance abuse (smoke or tobacco use within past 3 years) or significant intake of alcohol or history of alcoholism
* Patient not willing to use adequate contraception during study period and up to 4 weeks after last dose of study drug (unless sterilized).
* Debilitating psychiatric disorder such as psychosis or neurological condition that might confound outcome variables
* Inability or refusal to comply with protocol
* Not currently participating or having participated in an experimental drug study in previous three months
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02338193
Study Brief:
Protocol Section:
NCT02338193