Clinical trial · Observational
Insulin Resistance Before and During Pregnancy in Women With Polycystic Ovary Syndrome
Insulin Resistance Before and During Pregnancy in Women With PCOS
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Only 2 participants were enrolled
Summary
Brief summary (as posted)
The polycystic ovary syndrome (PCOS) affects about 10% of reproductive-age women. Women with PCOS are at a higher risk of gestational diabetes, which may lead to more pregnancy complications. It is unknown if there are factors that may predict which women are more at risk. The goal of this study is to evaluate the risk factors of gestational diabetes, such as dietary and physical activity factors, race, and how the body handles its own hormones during pregnancy. Our long term goal is to contribute in finding ways to successfully prevent gestational diabetes.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Insulin Resistance | — | UNRESOLVED | — |
| Insulin Sensitivity | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
| Pregnancy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- African-American women
- description
- Observational study--no intervention
- label
- Caucasian women
- description
- Observational study--no intervention
Primary outcomes (2)
- measure
- Change from Gestation Week 12-14 in Estrogen Metabolites at Gestation Week 32-34
- timeFrame
- Gestation weeks 12-14, 24-26, and 32-34
- measure
- Change from Gestation Week 12-14 in Insulin Sensitivity at Gestation Week 32-34
- timeFrame
- Gestation weeks 12-14, 24-26, and 32-34
Secondary outcomes (10)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of PCOS prior to pregnancy * 18-40 years of age * Documented BMI 30-40 kg/m2 (within 3 months prior to pregnancy or within 8 weeks of gestation) * Either of Caucasian or African-American decent by self report. * Pregnant or attempting pregnancy Exclusion Criteria: * Preexisting Diabetes (impaired glucose tolerance will not be an exclusion criterion because of the high prevalence of impaired glucose tolerance in the PCOS population). * Hemoglobin \< 8 or hemoglobin \<10 with symptoms of anemia. * Use of tobacco, alcohol or illicit substances.
References
Publications (0)
Data not yet available