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

CompletedNA

Sponsor: University of Michigan

Conditions: Obesity; Familial, Pregnancy Related

Interventions: Very-low energy Diet (VLED), Standard of care (SOC)

Countries: United States

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 overview

Sex: FEMALE

Age: 18 Years to 40 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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

Locations (1)

Ann Arbor, Michigan, United States