NCT01649167

Brief Summary

Background: Obesity in pregnancy is increasing and is a risk factor for metabolic pathology such as preeclampsia. Leptin is an adipokine which has a direct relationship to obesity. Aim: to measure leptin in lean, obese and diabetic pregnant women at three months intervals throughout their pregnancies. Methods: Pregnant women were recruited in the 1st trimester of pregnancy, and three groups were formed: a) with pregestational Body Mass Index (BMI) less than 25 kg/m2, b) BMI higher than 25 kg/m2 and c) with Gestational Diabetes Mellitus (GDM). Serum levels of leptin were measured with radioimmunoassay (RIA) technique.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 25, 2012

Completed
Last Updated

July 25, 2012

Status Verified

July 1, 2012

First QC Date

July 17, 2012

Last Update Submit

July 24, 2012

Conditions

Keywords

body mass indexgestational diabetesleptinobesitypregnancy.

Study Arms (3)

Overweight/obesity

Pregnant women with overweight/obesity

gestational diabetes

Pregnant women with gestational diabetes

normal weight

Pregnant women with normal weight

Eligibility Criteria

Age16 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women who had received medical attention during pregnancy at the HMPMP in Toluca, Mexico.

You may qualify if:

  • Women in the first trimester of pregnancy who sought medical attention at the HMPMP, between 16 and 46 years of age with a singleton gestation.

You may not qualify if:

  • A previously known chronic metabolic disease (diabetes, pregestational dyslipidemia, hypertension, collagen vascular diseases, inflammatory bowel disease and chronic inflammatory conditions, or corticosteroid use).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Diabetes, GestationalObesity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Verónica Jackeline García Solorio, MSc

    Autonomous University of the State of Mexico

    PRINCIPAL INVESTIGATOR
  • Hugo Mendieta Zerón, PhD

    Autonomous University of the State of Mexico

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher of the Medical Research Center (CICMED)

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 25, 2012

Study Start

February 1, 2009

Study Completion

November 1, 2010

Last Updated

July 25, 2012

Record last verified: 2012-07