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

University of Michigan

Status: Completed

Conditions: Obesity; Familial; Pregnancy Related

Treatments: Other: Standard of care (SOC); Dietary Supplement: Very-low energy Diet (VLED)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03244722

1R01DK124862 (U.S. NIH Grant/Contract)

HUM00124673

Details and patient eligibility

About

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.

Full 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 compared to standard practice nutrition counseling and support (SOC) group and approach the profiles found in normal weight (LEAN) individuals. We will relate these changes to the changes in the offspring clinical profiles. With these data in hand, we will develop a model to understand the potential molecular markers associated with offspring size and adiposity at birth, risk factors for later onset non-communicable diseases. We will use these insights to define, adopt and implement future interventions that mitigate the downstream risk of adiposity and cardiometabolic diseases.

Enrollment: 147 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 3 patient groups

Obese - Very low energy diet (VLED)

Other group

Description:

Participants will adopt a very-low energy diet

Treatment:

Dietary Supplement: Very-low energy Diet (VLED)

Obese - Standard of care (SOC)

Other group

Description:

Participants will receive the standard of care for obese women looking to become pregnant.

Treatment:

Other: Standard of care (SOC)

Lean - Standard of care (SOC)

Other group

Description:

Participants will receive the standard of care for lean women looking to become pregnant.

Treatment:

Other: Standard of care (SOC)