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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number. 2007-005019-25 |
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It was very difficult to fulfill the inclusion criteria, therefore the expected time of inclusion was delayed so much time.
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The metabolic syndrome represents a constellation of risk factors associated to the abdominal obesity that includes insulin resistance, lipids alterations, high blood pressure etc. Several studies support the hypothesis that the intake of soluble fiber might have a positive effect in the improvement of such of these risk factors.
So that, the aim of this study is to evaluate the efficacy of Ispaghula husk in the remission of metabolic syndrome in children between 10 to 16 years old.
The prevalence of the metabolic syndrome is increasing in the last decade as well in adult people as in children and adolescents. The early diagnosis and treatment measures could be very important in order to reduce the cardiovascular risk in such populations.
Ispaghula husk could be efficacious to reach the remission of the syndrome due to its effects in several important lipidic parameters.
The study will consist in the treatment with Ispaghula husk during 4 months in patients with metabolic syndrome. The main variable is the remission of the metabolic syndrome following the IDF(International Diabetes Federation) criteria specifics for children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ispaghula husk | Drug | 1 sachet of effervescent powder containing 5 gr of product (3.5 g of Ispaghula husk), b.i.d. during 16 weeks. Oral route. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission of the metabolic syndrome following the IDF criteria for children, it means, waist circumference lower than 90 percentile of the population according to the age. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the body weight | 16 weeks | |
| Change in the lipid profile | 16 weeks | |
| Change in the insulin resistance measured by HOMA index |
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Inclusion Criteria:
Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jordi Salas, MD, PhD | Hospital Universitari San Joan de Reus (Tarragona) | Study Chair |
| Luis Peña, MD, PhD | Hospital Univer. Materno-Infantil de Canarias ( Las Palmas de Gran Canaria) | Principal Investigator |
| Margarita Alonso, MD, PhD | Hospital Universitario de Valladolid | Principal Investigator |
| Sergio Pinillos, MD | Hospital Univ. Sant Joan de Déu ( Esplugues de Llobregat, Barcelona) | Principal Investigator |
| Joan Bel, MD, PhD | Hospital Universitari Germans Trias i Pujol ( Badalona) | Principal Investigator |
| Gloria Bueno, MD, PhD | Hosp. ClÃnico Universitario de Zaragoza | Principal Investigator |
| Rosaura Leis, MD, PhD | Hospital ClÃnico Univ. de Santiago de Compostela | Principal Investigator |
| Teresa Muñoz, MD, PhD | Hospital Univ. del Niño Jesús (Madrid) | Principal Investigator |
| Albert Feliu, MD PhD | Hospital Univ. San Joan de Reus (Tarragona) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari San Joan de Reus | Reus | Tarragona | 43201 | Spain |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C000713628 | ispaghula seed |
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| Placebo | Drug | 1 sachet of effervescent powder b.i.d. during 16 weeks, oral route. |
|
| 16 weeks |
| Change in inflammatory parameters as PCR, IL-6, IL-10, adiponectin | 16 weeks |
| Changes in blood pressure | 16 weeks |
| Tolerability of the treatment | 16 weeks |
| Principal Investigator |
| D009750 |
| Nutritional and Metabolic Diseases |