Clinical Trials Logo

Clinical Trial Summary

Randomized, double-blind placebo controlled trial of fish oil to decrease inflammation in pregnancy.


Clinical Trial Description

In addition to the increase in obesity in adult and children, there has been a significant increase in birth weights over the last 2 decades. Based on our preliminary data, maternal pre-gravid obesity is the strongest risk factor for neonatal as well as adolescent obesity. The long-term goals of our research are to examine therapeutic strategies to decrease fetal adiposity. Obesity and pregnancy are both insulin resistant conditions associated with chronic low-grade inflammation. Therefore, we hypothesize that n-3 PUFA dietary supplements during pregnancy will act as insulin sensitizers decreasing peripheral insulin resistance and inflammation. If correct this mechanism should decrease availability of maternal nutrients to the fetus and subsequently reduce adiposity at birth. We plan a prospective randomized double blind control trial of n-3 PUFA supplementation and placebo in overweight/obese women, with a previous cesarean delivery, initiated in early pregnancy and maintained throughout pregnancy. This proposal has two specific aims. Specific aim 1 is to evaluate the effect of n-3 PUFA supplementation on maternal insulin sensitivity. Measures of maternal insulin sensitivity and lipid metabolism will be made using the ISogtt, indirect calorimetry body composition (BODPOD) and plasma lipid profile at baseline and after dietary intervention.

Specific aim 2 will assess the effect of n-3 PUFA on the inflammatory status in overweight/obese pregnant women. We hypothesize that n-3 PUFA supplementation decreases chronic inflammation during pregnancy by preventing monocyte activation and accumulation of macrophages in WAT thus lowering systemic concentration of pro-inflammatory cytokines. We plan to characterize the longitudinal changes in circulating monocytes and plasma adipokines in order to define the inflammatory patterns in both groups over time. We will also determine the abundance and phenotype of macrophages infiltrating WAT using flow cytometry, immunohistochemistry and gene expression profiling. Furthermore, the role of PPARγ as a central target of n-3 PUFA action to regulate insulin sensitivity will be examined by characterizing the expression of PPARγ in WAT of both supplemented and control groups. Additionally, we will investigate the direct affect of n-3 PUFA on the expression of adiponectin and PPARγ regulated genes in primary cultured adipocytes.

In summary, this proposal combines both clinical and molecular methodologies in an overweight/obese subject population in order to assess the effect of n-3 PUFA on inflammation and insulin resistance. Preliminary data will also be obtained on fetal body composition in order to later address the prevention of the long term adverse effects (developmental programming) of maternal obesity in the developing fetus. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT00957476
Study type Interventional
Source MetroHealth Medical Center
Contact
Status Completed
Phase N/A
Start date September 2009
Completion date June 2013

See also
  Status Clinical Trial Phase
Recruiting NCT04101669 - EndoBarrier System Pivotal Trial(Rev E v2) N/A
Recruiting NCT04243317 - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults N/A
Terminated NCT03772886 - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball N/A
Completed NCT03640442 - Modified Ramped Position for Intubation of Obese Females. N/A
Completed NCT04506996 - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2 N/A
Recruiting NCT06019832 - Analysis of Stem and Non-Stem Tibial Component N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Active, not recruiting NCT05275959 - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI) N/A
Recruiting NCT04575194 - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy Phase 4
Completed NCT04513769 - Nutritious Eating With Soul at Rare Variety Cafe N/A
Withdrawn NCT03042897 - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer N/A
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Recruiting NCT05917873 - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation N/A
Active, not recruiting NCT04353258 - Research Intervention to Support Healthy Eating and Exercise N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Completed NCT01870947 - Assisted Exercise in Obese Endometrial Cancer Patients N/A
Recruiting NCT06007404 - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Recruiting NCT05371496 - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction Phase 2