Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention
Overview[ - collapse ][ - ]
Purpose | 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. |
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Condition | Obesity |
Intervention | Drug: Metformin Behavioral: Dietary modification with caloric restriction Behavioral: Establishment of exercise protocol |
Phase | N/A |
Sponsor | Nemours Children's Clinic |
Responsible Party | Nemours Children's Clinic |
ClinicalTrials.gov Identifier | NCT00139477 |
First Received | August 29, 2005 |
Last Updated | October 21, 2012 |
Last verified | October 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | August 29, 2005 |
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Last Updated Date | October 21, 2012 |
Start Date | November 2003 |
Estimated Primary Completion Date | September 2011 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Study of Serum Markers for Cardiovascular Risk in Obese Youth and Impact of Lifestyle and Medication Intervention |
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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. |
Brief Summary | 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. |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Obesity |
Intervention | Drug: Metformin Metformin, 250mg by mouth twice a day with meals will be started and if tolerated increased to 500mg twice a day in 3 days in those less than 12 years old and titrated further to 1000mg twice a day if tolerated. Behavioral: Dietary modification with caloric restriction The life style intervention changes will include a hypocaloric diet representing at least a 500 kcal/day reduction based on their dietary histories and Resting Energy Expenditure (REE) determined by the initial calorimetry. Behavioral: Establishment of exercise protocol Participants will attend the Fitness Center 3 times per week and supervised by an exercise technician or exercise specialist. Exercise will be individually prescribed for each participant based on their functional abilities. Exercise will consist of 5-10 minutes for warm up and stretching, followed by 15-30 minutes of cardiovascular exercise (i.e. treadmill, bicycle ergometer, rower, nustep, etc), 10-20 minutes of strength training (supervised using weight stack equipment), and 5-10 minutes of cool down and stretching. As children typically do not need an exercise prescription based on heart rate, we will familiarize them with perceived exertion scales and monitor that they are exercising in the moderate to hard range of perception of effort. Participants will be started at 15 minutes of cardiovascular exercise and 10 minutes of strength training exercise, progressing by 2-3 minutes every week until 30 and 20 minutes is achieved for each respectively. |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 66 |
Estimated Completion Date | September 2011 |
Estimated Primary Completion Date | May 2009 |
Eligibility Criteria | 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. |
Gender | Both |
Ages | 7 Years |
Accepts Healthy Volunteers | Accepts Healthy Volunteers |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00139477 |
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Other Study ID Numbers | 04-032 |
Has Data Monitoring Committee | Yes |
Information Provided By | Nemours Children's Clinic |
Study Sponsor | Nemours Children's Clinic |
Collaborators | Thrasher Research Fund |
Investigators | Principal Investigator: Nelly Mauras, MD Nemours Children's Clinic |
Verification Date | October 2012 |
Locations[ + expand ][ + ]
Nemours Children's Clinic | Jacksonville, Florida, United States, 32207 |
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