Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2008-10-31
2012-10-31
Brief Summary
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Detailed Description
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Aim 1. Identify and enroll pediatric cohort with obesity or obesity/NAFLD to study the role of the intestinal microbiome on the development of NAFLD.
1. Enroll participants through the NEW Kids program for treatment of pediatric obesity at Children's Hospital of Wisconsin (CHW). Identify and classify participants through initial clinical evaluation, collect clinical metadata, and obtain and process blood and stool samples for analysis. Demonstrate feasibility by showing that participants can be recruited and participate in the specific study protocol.
2. Follow study population through nutritional/exercise intervention, with follow up collection of clinical data, stool, and blood samples.
Aim 2. Characterize the intestinal microbiome through quantitative PCR and high throughput sequencing analysis of stool specimens in participants with obesity and obesity/NAFLD.
1. Demonstrate feasibility by showing that sampling aliquots from patient fecal samples can be successfully analyzed by proposed methods and yield consistent results for duplicate samples.
2. Compare sequencing results and metagenomic analysis for study groups with particular attention to bacterial composition and metabolic capacity associated with energy harvest, lipid and carbohydrate transport, enhancement of epithelial barrier integrity, and choline metabolism.
3. Investigate whether intervention (nutritional/exercise) results in longitudinal alterations in the intestinal microbiome.
Aim 3. Characterize evidence of systemic inflammation by C-reactive protein (CRP), Tumor necrosis factor alpha (TNF-alpha)Transforming growth factor beta 1 (TGF-beta and LPS Binding Protein (LBP) levels, and analyze results in relationship to the intestinal microbiome and the presence of NAFLD.
1. Compare levels of systemic inflammatory markers of participants with obesity vs. obesity/NAFLD
2. Investigate whether intervention (nutritional/exercise) results in longitudinal alterations in systemic inflammation.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Controls
Obese (BMI\>30) and normal AST and ALT. Between the ages of 5 and 18 years old.
Blood Draw
2 tablespoons of blood will be drawn from participants at study entry, 3 months after study entry, and 6 months after study entry.
Stool collection
Stool will be collected from participants 3 times during the study -- at study entry, 3 months from study entry, and 6 months after study entry.
BodPod Measurement
Body composition will be measured using a BodPod at study entry, 3 months after study entry, and 6 months after study entry.
Liver Ultrasound
A liver ultrasound will be performed at study entry and 6 months after study entry.
Liver Disease
Obese (BMI\>30) and elevated AST and/or ALT (evidence of NAFLD). Between the ages of 5 and 18 years old.
Blood Draw
2 tablespoons of blood will be drawn from participants at study entry, 3 months after study entry, and 6 months after study entry.
Stool collection
Stool will be collected from participants 3 times during the study -- at study entry, 3 months from study entry, and 6 months after study entry.
BodPod Measurement
Body composition will be measured using a BodPod at study entry, 3 months after study entry, and 6 months after study entry.
Liver Ultrasound
A liver ultrasound will be performed at study entry and 6 months after study entry.
Interventions
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Blood Draw
2 tablespoons of blood will be drawn from participants at study entry, 3 months after study entry, and 6 months after study entry.
Stool collection
Stool will be collected from participants 3 times during the study -- at study entry, 3 months from study entry, and 6 months after study entry.
BodPod Measurement
Body composition will be measured using a BodPod at study entry, 3 months after study entry, and 6 months after study entry.
Liver Ultrasound
A liver ultrasound will be performed at study entry and 6 months after study entry.
Eligibility Criteria
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Inclusion Criteria
* Willing to consent/undergo necessary procedures
* Obese (BMI\>30)
* Speak English or Spanish
Exclusion Criteria
* any chronic illnesses or life threatening conditions
5 Years
18 Years
ALL
No
Sponsors
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Medical College of Wisconsin
OTHER
Responsible Party
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Medical College of Wisconsin
Principal Investigators
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Vincent Biank, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital and Health System Foundation, Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Angulo P, Keach JC, Batts KP, Lindor KD. Independent predictors of liver fibrosis in patients with nonalcoholic steatohepatitis. Hepatology. 1999 Dec;30(6):1356-62. doi: 10.1002/hep.510300604.
Iacobellis A, Marcellini M, Andriulli A, Perri F, Leandro G, Devito R, Nobili V. Non invasive evaluation of liver fibrosis in paediatric patients with nonalcoholic steatohepatitis. World J Gastroenterol. 2006 Dec 28;12(48):7821-5. doi: 10.3748/wjg.v12.i48.7821.
Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006 Dec 21;444(7122):1027-31. doi: 10.1038/nature05414.
Li Z, Soloski MJ, Diehl AM. Dietary factors alter hepatic innate immune system in mice with nonalcoholic fatty liver disease. Hepatology. 2005 Oct;42(4):880-5. doi: 10.1002/hep.20826.
Brun P, Castagliuolo I, Di Leo V, Buda A, Pinzani M, Palu G, Martines D. Increased intestinal permeability in obese mice: new evidence in the pathogenesis of nonalcoholic steatohepatitis. Am J Physiol Gastrointest Liver Physiol. 2007 Feb;292(2):G518-25. doi: 10.1152/ajpgi.00024.2006. Epub 2006 Oct 5.
Fields DA, Goran MI, McCrory MA. Body-composition assessment via air-displacement plethysmography in adults and children: a review. Am J Clin Nutr. 2002 Mar;75(3):453-67. doi: 10.1093/ajcn/75.3.453.
Nicholson JC, McDuffie JR, Bonat SH, Russell DL, Boyce KA, McCann S, Michael M, Sebring NG, Reynolds JC, Yanovski JA. Estimation of body fatness by air displacement plethysmography in African American and white children. Pediatr Res. 2001 Oct;50(4):467-73. doi: 10.1203/00006450-200110000-00008.
Other Identifiers
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GC 727
Identifier Type: -
Identifier Source: secondary_id
CHW 08/159
Identifier Type: -
Identifier Source: org_study_id
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