Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes

Sex: Female

Ages: 18 Years – 40 Years

Healthy volunteers: Yes

Phase: NA

Enrollment: 147

Sponsor: University of Michigan

Summary

Our hypothesis is that aggressive preconception weight loss in obese women will improve the metabolic health of the mother and the intrauterine environment. An optimized developmental environment will normalize fetal growth and improve clinical fetal and infant outcomes, and theoretically reduce future susceptibility to obesity and cardiometabolic disease.

Eligibility Criteria

Inclusion Criteria: * BMI \> 30 ≤ 45 for obese participants OR * BMI ≤ 25 for healthy body weight participants * No known infertility * No known risk factors for tubal disease Exclusion Criteria: * Significant medical co-morbidities (e.g. heart, kidney, liver, autoimmune disease) * Significant anemia * Cancer other than minor skin cancers * Conditions that would complicate pregnancy * Recent use of anti-obesity drugs or appetite suppressants * Previous bariatric surgery * Endometriosis AFS (American Fertility Society classification class III or IV) * Progesterone \> 10 IU/ml * Current pregnancy * Use of sperm donor

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03244722). StuddyBuddy aggregates publicly available trial information.