Multicenter, Double Blind, Randomized, Controlled With Placebo, to Evaluate the Effect of the Treatment With Plantago Ovata Husk in the Incidence of the Remission of Metabolic Syndrome in Children and Adolescents Between 10 to 16 Years Old.
Overview
- Phase
- Phase 2
- Intervention
- Ispaghula husk
- Conditions
- Metabolic Syndrome
- Sponsor
- Rottapharm Spain
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
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 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.
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
1
Intervention: Ispaghula husk
2
Intervention: Placebo
Outcomes
Primary Outcomes
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.
Time Frame: 16 weeks
Secondary Outcomes
- Change in the body weight(16 weeks)
- Change in the lipid profile(16 weeks)
- Change in the insulin resistance measured by HOMA index(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)