Status:
COMPLETED
Maternal Metabolic and Molecular Changes Induced by Preconception Weight Loss and Their Effects on Birth Outcomes
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Obesity; Familial
Pregnancy Related
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief 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...
Detailed Description
Further, our hypothesis is that the metabolic profiles in the mother and infant cord blood and epigenetic profiles in cord blood leukocytes will be improved in the very-low energy diet (VLED) group co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT03244722
Start Date
April 10 2018
End Date
August 29 2025
Last Update
September 10 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48106