Is Fructose Linked to Adiposity in Babies?

NCT01262781 | Completed

• 1 other identifier: SFGH 6281
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The obesity epidemic has reached down into the infant and toddler age group. Dietary indiscretion during pregnancy, particularly in our current food environment, is a major risk factor for both gestational diabetes and neonatal macrosomia (\>4kg newborns), which is itself a risk factor for obesity and metabolic syndrome in the offspring, possibly even during childhood. Temporal increases in fructose consumption in the last two decades coincide with temporal increases weight gain during pregnancy and with increased birth weight, including a higher prevalence of macrosomic newborns. Our central hypothesis is that higher fructose consumption during pregnancy is a risk factor for infant obesity and metabolic syndrome.

Conditions

Obesity; Metabolic Syndrome

Keywords

neonatal adiposity; metabolic syndrome; fructose; maternal diet

Outcome Measures

Primary Outcomes (1)

• % adiposity (DEXA)

  After delivery, neonatal adiposity will be measured using DEXA.

  After delivery, neonatal adiposity will be measured using DEXA. This part of the protocol takes place 4-5 months after recruitment.

Secondary Outcomes (6)

• cord blood insulin (corrected by cord blood glucose)

  At delivery (in the OR): 4-5 months after recruitment

• cord blood triglycerides

  At delivery (in the OR): 4-5 months after recruitment

• cord blood leptin

  At delivery (in the OR): 4-5 months after recruitment

• anthropometric measurements on the newborn

  After delivery (4-5 months after recruitement)

• fetal fractional thigh volume obtained by fetal ultrasound

  At 32 weeks gestation (4 months after recruitment)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women between 18 to 40 years of age are eligible for this study

You may qualify if:

• Agreement to participate in all measurements
• Plans to remain in the area through delivery
• Ability to understand and give informed consent in either English or Spanish.

You may not qualify if:

• Presence of diabetes prior to the index pregnancy
• Presence of gestational diabetes during a previous pregnancy
• Presence of diabetes or of other chronic metabolic disease such as cardiovascular disease, active thyroid disease, liver disease, pulmonary or psychiatric disorders, HIV
• Any disorder requiring diet therapy (i.e., renal insufficiency)
• Multiple gestation
• Prior history of intrauterine growth retardation
• Use of substances known to cause intrauterine growth retardation (e.g., smoking or drug use). -

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco General Hospital: collaborator

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Robert Lustig, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Anjali Jain, MD

  University of California, San Francisco

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2010
• First Posted: December 17, 2010
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

US (1)