Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT01131117
  4. Details
NCT01131117 Clinical Trial

Fetal Programming of Obesity

Healthy Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01131117
Other study ID # 110889
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2, 2010
Est. completion date August 2024

Study information
Verified date December 2023
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The overall goal of this project is to understand how a mother's health at conception may influence her child's growth and development.

Description:

The purpose of this study is to determine how the mother's health prior to or at the beginning of pregnancy may influence her child's growth and development. We plan to: 1) longitudinally and simultaneously assess a true measure of body composition (lean and fat mass) of the offspring, assess body composition of both parents, and obtain dietary intake data of the mother and offspring; 2) determine endocrine and metabolic profiles of the mother at baseline (pre-conception), during pregnancy and at birth (such as insulin, glucose, leptin); 3) determine the energy expenditure and physical activity of the mother and the child; 4) determine gene expression of the placenta and umbilical cord via gene microarray and real time PCR; and 5) focused on appropriate-for-gestational age (AGA) infants (the majority of infants born from normal and overweight mothers).Accordingly, this study will provide much needed comprehensive information on the possible effect of fetal programming on the development of pediatric obesity.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 320
Est. completion date August 2024
Est. primary completion date August 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 21 Years and older
Eligibility Inclusion Criteria: - healthy - 21 years of age or older - second pregnancy, singleton - conceived without fertility treatments Exclusion Criteria: - Preexisting medical conditions - Sexually transmitted diseases - Medical complications during pregnancy - Medications during pregnancy known to influence fetal growth - Smoking, alcohol drinking - Excessive physical activity level which could affect the outcome of interest.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Arkansas Children's Nutrition Center Little Rock Arkansas

Sponsors (1)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Child body composition lean and fat mass of the child 24 months
Secondary Child metabolism monitor with a metabolic cart 24 months
Secondary Child development Monitored from 2wks up to 24 months 24 months
Secondary Child dietary intake Food records for each visit will be obtained 24 months
Secondary Placenta gene expression via gene microarray and real time PCR 9 months
Secondary Placenta protein content via gene microarray and real time PCR 9 months
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1