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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03244722
Other study ID # HUM00124673
Secondary ID 1R01DK124862
Status Recruiting
Phase N/A
First received
Last updated
Start date April 10, 2018
Est. completion date August 31, 2025

Study information

Verified date September 2023
Source University of Michigan
Contact Shannon Considine, MPH, MSW
Phone 734-232-6483
Email sconsidi@umich.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 352
Est. completion date August 31, 2025
Est. primary completion date August 31, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Very-low energy Diet (VLED)
Structured, intensive dietary intervention using liquid meal replacements aimed at providing 800 kcal/day with a weight loss goal of 15% from baseline
Other:
Standard of care (SOC)
Standard consultation with registered dietitian to determine appropriate caloric deficit for a low calorie diet, education and advice to achieve weight loss in obese women. Standard of care for normal weight women

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (2)

Lead Sponsor Collaborator
University of Michigan National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Mode of delivery Categorical as caesarean or vaginal delivery Delivery
Other Fetal growth abnormalities Categorical as miscarriage, intrauterine growth restriction (IUGR), fetal demise, fetal anomalies Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks)
Other Maternal diagnosis Categorical as maternal cardiac dysfunction, maternal proteinuria, maternal sleep apnea, fatty liver disease, gestational diabetes, preeclampsia, indicated preterm birth date, failed trial of labor, endometritis, venous thrombosis, COVD-19, surgical wound complications, postpartum anemia, postpartum depression, early termination of breastfeeding. Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks), delivery
Primary Preconception weight loss Primary pre-specified outcome is BMI change (kg/m2) after dietary intervention. Trained staff will measure height and weight to the nearest .1cm and .1kg using a wall-mounted, precision stadiometer and calibrated digital scale. BMI will be calculated (kg/m2). Baseline to post dietary intervention (16 weeks)
Primary Metabolome and inflammatory markers Multivariate computational models will assess the association of maternal and neonate metabolite and inflammatory markers to fetal growth and newborn weight (g) and adiposity (g). Delivery
Primary Offspring body fat mass Percentage body fat (adiposity) in the offspring of women randomized to Very Low Energy Diet (VLED) compared to those randomized to Standard of Care (SOC). Body composition will be assessed by PeaPod (fat mass in grams). Delivery
Primary Cord blood related to neonate outcomes The maternal metabolome (~metabolites) will be related to neonate adiposity, gestational weight gain, pregnancy complications, and intrauterine fetal growth rate. Before and after dietary intervention (16 weeks), delivery
Primary DNA methylation Differences in site-specific DNA methylation (~450,000 sites) in offspring cord blood mononuclear cells between the Standard of Care (SOC), Very Low Energy Diet (VLED) and lean groups will be assessed. Delivery
Secondary Participant waist circumference in centimeters The change in waist circumference (cm) will be assessed using a retractable, soft nylon measuring tape. Baseline and post dietary intervention (16 weeks), each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks)
Secondary Fetal growth will be assessed by ultrasound Gestational sac dimensions (mm), fundal height (mm), biparietal diameter (mm), head circumference (mm), and waist circumference (mm) will be assessed through ultrasound to determine fetal growth. Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks)
Secondary Infant length and weight Trained staff will measure infant length and weight to the nearest .1cm and .1kg using an infant length board and digital infant scale at delivery, 2-, 4-, 6-, 9-, and 12-months. Ponderal index will be calculated and used to assess change in growth. Delivery to 12 month follow-up
Secondary Metabolite levels Relationships between metabolite levels (~2000 metabolites) in maternal blood at each trimester and cord blood mononuclear cell DNA methylation will be compared Each trimester of pregnancy (between 8-12 weeks, between 18-22 weeks, and between 28-34 weeks), delivery
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