Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention - Full Text View

Sponsors and Collaborators:	Nemours Children's Clinic Thrasher Foundation
Information provided by:	Nemours Children's Clinic
ClinicalTrials.gov Identifier:	NCT00139477

Purpose

The purpose of this study is to evaluate whether serum markers of inflammation and thrombosis, which ultimately increase cardiovascular risk (CRP, fibrinogen and others) are already abnormal in obese children that do not yet have other features of the metabolic syndrome. The investigators will assess the status of these risk factors in pubertal and prepubertal children ages 8-18 years, both lean and obese. The pubertal cohort that has elevations in these markers will participate in a longitudinal interventional study with lifestyle modification (diet and structured exercise) with or without Metformin for 6mo in a cross over design. Intrahepatic fat contents will be measured as well.

The investigators hypothesize that obese children in these age groups will have increased cardiovascular risk related to their obese state before reaching the currently defined criteria of metabolic syndrome.

The investigators hypothesize that these cardiovascular risks can be reduced with lifestyle and drug interventions.

Condition	Intervention
Obesity	Drug: Metformin Behavioral: Dietary modification with caloric restriction Behavioral: Establishment of exercise protocol

MedlinePlus related topics: Exercise and Physical Fitness Obesity Obesity in Children

Drug Information available for: Insulin Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Understanding the Effects of Therapeutic Intervention on Cardiovascular Risk Markers, Insulin Resistance, and Intra-Hepatic Fat Contents in Obese Children at High Risk for the Metabolic Syndrome.

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:

To determine if obese children without other features of the metabolic syndrome have increases in serum markers for cardiovascular risk even before the onset of puberty as compared to lean controls.

Secondary Outcome Measures:

To determine if exercise, diet, and/or drug therapy can improve the pro-thrombotic and pro-inflammatory state of obesity that we postulate exists prior to the metabolic syndrome.

Estimated Enrollment:	160
Study Start Date:	June 2005

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Ages 8-18 years.
Obese children are greater than the 95th percentile body mass index for their age and gender.
Lean children are between the 10th and 50th percentile body mass index for their age and gender.
Children are in Tanner Stage I or IV or V.
Normal Blood Pressure.
Normal fasting glucose.
Normal lipids.
Menstruating girls must have completed their most recent period at least 2 weeks prior to blood draw.
NO recent illness, no chronic illnesses, no routine medications, no smoking or alcohol intake.

Exclusion Criteria:

Chronic active illnesses.
Recent illnesses.
Use of routine medications, vitamins, herbal remedies, oral contraceptive pills, or other over the counter medications within 4 weeks of blood draw.
History of recent or chronic smoking.
Currently pregnant.
For the lean control group, immediate family history of Type 2 Diabetes mellitus or Hypertension or Hyperlipidemia.
Impaired fasting glucose.
Dyslipidemia.
Actively in puberty.
Weight greater than 300 pounds.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139477

Locations

United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207

Sponsors and Collaborators

Nemours Children's Clinic

Thrasher Foundation

Investigators

Principal Investigator:

Nelly Mauras, MD

Nemours Children's Clinic

More Information

A website describing the study and pre-screening children with eligibility questions This link exits the ClinicalTrials.gov site

Study ID Numbers:	04-032
Study First Received:	August 29, 2005
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00139477
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Metformin
Nutrition Disorders

Overweight
Overnutrition
Insulin Resistance
Insulin

ClinicalTrials.gov processed this record on January 16, 2009