Status:
TERMINATED
Trial to Evaluate the Effect of Plantago Ovata Husk in the Remission of Metabolic Syndrome in Children and Adolescents
Lead Sponsor:
Rottapharm Spain
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
10-16 years
Phase:
PHASE2
Brief Summary
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 sup...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Children between 10 to 16 years old with diagnostic criteria of metabolic syndrome following the IDF criteria:
- Waist circumference \> or equal to percentile 90 according the age.
- Presence of 2 or more of following factors: systolic blood pressure \> or equal 130 mmHg or diastolic \> or equal to 85 mmHg, or treated hypertension
- Cholesterol HDL \< 1.03 mmol/l or treatment with drugs to increase cHDL
- Glucose blood levels \> 5.6 mmol/l or type II diabetes diagnosed treated or no.
Exclusion
- Loss of body weight \> 3kg in the last 2 months
- Waist circumference 10 cm higher of 90 percentile according to the age
- Intake of fiber, aven supplements or phytosterols in the last 2 months
- Glycosylate haemoglobin \>7% in the time of inclusion
- Systolic blood pressure \> 145 mmHg or Diastolic blood pressure \>95 mmHg.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00748787
Start Date
October 1 2008
End Date
June 1 2010
Last Update
June 8 2011
Active Locations (1)
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1
Hospital Universitari San Joan de Reus
Reus, Tarragona, Spain, 43201