Status:
COMPLETED
ZIMBA: Clinical Trial in Paediatric Obesity
Lead Sponsor:
Azienda Ospedaliero Universitaria Maggiore della Carita
Conditions:
Obesity, Childhood
Insulin Resistance
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief Summary
Myoinositol (MI) and D-chiro inositol (DCI) are isomeric forms of inositol that were found to have insulin-like properties, acting as second messengers in the insulin intracellular pathway; both of th...
Detailed Description
Study design: A single-center pilot open-label randomized control trial. Population: The study will comprise a total of 60 subjects of both sexes, with pubertal stage ≥ 3 according to the Tanner stage...
Eligibility Criteria
Inclusion
- both sexes
- between 6 and 18 years of age
- obese, according to the IOTF criteria (Cole TJ et al., 2000)
- pubertal stage ≥ 3 according to the Tanner stage (Tanner et al., 1961)
- HOMA-IR \> 2,5 or insulin \> 15 µU/ml
- Serum Zinc level in the range of normality or under the normal levels.
Exclusion
- Adverse reactions to the product or component of the product (allergies…)
- Genetic obesity (Prader Willi syndrome, Down syndrome), Metabolic obesity (Laurence-Biedl syndrome…), endocrinological obesity (Cushing syndrome, hypothyroidism)
- Chronic diseases, hepatic or gastroenterological diseases
- Medical treatment for chronic diseases
- Supplementation with inositol-like products or supplements containing Zinc and Inositol.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2024
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03283813
Start Date
February 5 2018
End Date
March 10 2024
Last Update
August 9 2024
Active Locations (1)
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1
AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica
Novara, Italy, 28100