Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention

Nemours Children's Health

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Establishment of exercise protocol; Behavioral: Dietary modification with caloric restriction; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00139477

04-032

Details and patient eligibility

About

In Protocol #2, we will select 30 obese pubertal and 30 obese prepubertal subjects with an abnormal cytokine profile (i.e. fibrinogen and/or hsCRP concentration greater than or equal to 2 Standard Deviations (SD) above the mean established in our lab for lean controls in Protocol #1). They will be randomly assigned to either lifestyle intervention (diet/exercise) or diet/exercise plus metformin for 6 months. After the 6 month evaluation the subjects will cross over the treatment arms, i.e., those that were doing diet/exercise intervention only will add metformin, those that were doing the diet/exercise plus metformin will discontinue the metformin and continue with diet/exercise changes only. 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.

Enrollment: 66 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Ages 7-18 years.
• Greater than the 95th 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.
• Must pass the screening test done in Protocol #1.
• Must have higher values than normal for certain blood tests related to heart disease that were measured in Protocol #1.

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.
• Impaired fasting glucose.
• Dyslipidemia.
• Actively in puberty.
• Weight greater than 300 pounds.
• Metal in the abdomen.
• History of being overweight greater than 5 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

Diet/Exercise only, then Diet/Exercise plus Metformin

Experimental group

Description:

Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).

Treatment:

Behavioral: Establishment of exercise protocol

Drug: Metformin

Behavioral: Dietary modification with caloric restriction

Diet/Exercise plus Metformin, then Diet/Exercise only

Active Comparator group

Description:

Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).

Treatment:

Behavioral: Establishment of exercise protocol

Drug: Metformin

Behavioral: Dietary modification with caloric restriction