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 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT01823367
Eligibility Criteria:
Inclusion Criteria:
* Adult females, age 18 or greater
* Body-mass index of ≥ 25 kg/m2
* Is a biological mother to a child between 8 and 15 years of age (child must live with biological mom)
* Is a biological mother with past diagnosis or history of gestational diabetes, prediabetes or gave birth to a child who weighed 9 pounds or greater at delivery
* Child, ages 8 to 15 years, to biological mother meeting inclusion criteria for Adult Females
Exclusion Criteria:
* Biological mother or biological child with diagnosis of Type 1 or 2 Diabetes Mellitus
* Biological mother or biological child with current A1c \> 6.5%
* Biological mother or biological child current casual capillary blood glucose \> 220mg/dl
* Biological mother or biological child with uncontrolled hypertension (Systolic Blood Pressure (SBP) \>180 mmHg or Diastolic Blood Pressure (DBP) \>105 mmHg)
* Biological mother or biological child with heart attack, stroke, or transient ischemic attack in the past 6 months
* Biological mother or biological child with chest pain, dizziness, or fainting with physical exertion
* Biological mother or biological child with Chronic Obstructive Pulmonary Disease (COPD) or asthma requiring home oxygen
* Biological mother or biological child with cancer treatment in the last 5 years
* Biological mother or biological child with any other known condition that could limit ability to become physically active or limit life span to \<5 years
* Biological mother or biological child with history of anti-diabetic medication use (oral agents or insulin) except during past gestational diabetes
* Biological mother or biological child with self-report of any other condition associated with disordered glucose metabolism (including but not limited to):pregnancy; Cushing's syndrome; acromegaly; pheochromocytoma; chronic pancreatitis
* Biological mother or biological child with conditions or behaviors likely to affect the conduct of the study (including but not limited to): any reported developmental problems, unable or unwilling to provide informed consent/assent, unable or unwilling to communicate with study staff or engage in learning activities
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT01823367
Study Brief:
Protocol Section:
NCT01823367