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ZIMBA: Clinical Trial in Paediatric Obesity (ZIMBA)

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ClinicalTrials.gov Identifier: NCT03283813
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Simonetta Bellone, Azienda Ospedaliero Universitaria Maggiore della Carita

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 these molecules are involved in the increasing insulin sensitivity of different tissues to improve metabolic and ovulatory functions. Myoinositol is the predominant form that can be found in nature and food.

Inositol has been mainly used as a supplement in treating several pathologies such as polycystic ovary syndrome (PCOS), metabolic syndrome, type 2 diabetes mellitus (T2DM) and gestational diabetes (GDM). In the case of GDM, a condition defined as a glucose impairment first detected in pregnancy, a preventive role of inositol for GDM onset was recognized. In addition, inositol has been studied as a therapeutic option for the treatment of GDM and T2DM. The main effect of inositol is decreasing the level of insulin resistance. Consequently, a potential role of inositol as a treatment option could be hypothesized for other conditions typically characterized by insulin resistance like metabolic syndrome and obesity.

Zinc also plays an important role in insulin action and carbohydrate metabolism. It may also have a protective role in the prevention of atherogenesis. Several human studies have demonstrated that Zinc supplementation reduces total cholesterol, LDL cholesterol and triglycerides, in addition to increasing the HDL cholesterol levels. Studies have shown that diabetes is accompanied by hypozincemia and high levels of Zinc in urine. In addition Zinc is also an integral part of key anti-oxidant enzymes and Zinc deficiency impairs their synthesis, resulting in increased oxidative stress.

A supplementation with Myo-Inositol and Zinc could represent a valid strategy in paediatric obesity in addiction to a standard approach. The purpose of our study is to evaluate the supplementation of Myo-inositol and Zinc in the treatment of paediatric obesity.


Condition or disease Intervention/treatment Phase
Obesity, Childhood Insulin Resistance Zinc Deficiency Inositol Dietary Supplement: Zinc Drug: Placebos Drug: Myoinositol Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The study is a triple blind study in which the treatment or intervention is unknown to the research participant, the individuals who administer the treatment or intervention, and the researchers who assess the outcomes.
Primary Purpose: Treatment
Official Title: Effects of a Supplementation With Zinc and Myo-inositol in Paediatric Obesity
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active group - Zinc and Myo-inositol
This arm will receive a supplementation with Zinc and Myo-inositol once a day.
Dietary Supplement: Zinc
In this active Group there will be a supplementation with Zinc (5 mg), Myo-inositol (2000 mg) and GOS (Galacto-oligosaccharides) of Pisum sativum (1000 mg)

Drug: Myoinositol
In this active Group there will be a supplementation with Zinc (5 mg), Myo-inositol (2000 mg) and GOS (Galacto-oligosaccharides) of Pisum sativum (1000 mg)

Placebo Comparator: Placebo group
This arm will receive a supplementation with a same product equal to the active product but without Zinc and Myo-inositol inside.
Drug: Placebos
In this placebo Group there will be a supplementation with a product placebo equal to the active product with GOS (Galacto-oligosaccharides) of Pisum sativum(1000 mg) but without Zinc and Myo-inositol.




Primary Outcome Measures :
  1. Change in HOMA-IR index [ Time Frame: Change from baseline HOMA-IR (V0) at 3 months (V1). ]

    Evaluate if after the treatment with Myoinositol and Zinc supplementation there is a variation of HOMA-IR index.

    Evaluate if after the treatment with probiotic there is a variation of HOMA-IR index.



Secondary Outcome Measures :
  1. Change in glucose level during oral glucose tolerance test (OGTT) [ Time Frame: Change from Baseline OGTT (V0) at 3 months (V1) ]
    Evaluate if after the treatment with Myoinositol and Zinc supplementation there is a reduction of glucose values during the OGTT at time 0' e 120' after oral glucose tolerance test.

  2. Metabolic control: Improvement of metabolic risk factors [ Time Frame: Change from baseline lipid profile, insulin, leptin, adiponectin, GLP1 (V0) at 3 months (V1) ]
    Evaluate any variation of serum lipids, leptin, adiponectin, GLP1 and insulin during OGTT.


Other Outcome Measures:
  1. Change in inflammatory cytokines. [ Time Frame: Change from Baseline cytokines and metabolites (V0) at 3 months (V1). ]
    Evaluate new cytokines and metabolites that regulates hormone metabolism.



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283813


Contacts
Contact: Simonetta Bellone, Assoc. Professor 0390321660693 simonetta.bellone@med.uniupo.it

Locations
Italy
AOU Maggiore della Carità - Clinica Pediatrica - Ambulatorio di Auxologia ed Endocrinologia Pediatrica Recruiting
Novara, Italy, 28100
Contact: Simonetta Bellone, Professor    0390321660693    simonetta.bellone@med.uniupo.it   
Sponsors and Collaborators
Azienda Ospedaliero Universitaria Maggiore della Carita

Publications:
Tanner JM. (1961). Growth at adolescence. 2 edn. Oxford: Blackwell Scientific Publications.
Società Italiana di Nutrizione Umana.(2014).Livelli di assunzione raccomandati di energia e nutrienti per la popolazione italiana (LARN). Milan, Italy: S.I.N.U.

Responsible Party: Simonetta Bellone, Assoc. Professor, Azienda Ospedaliero Universitaria Maggiore della Carita
ClinicalTrials.gov Identifier: NCT03283813     History of Changes
Other Study ID Numbers: CE 99/17
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Simonetta Bellone, Azienda Ospedaliero Universitaria Maggiore della Carita:
Paediatric Obesity
Insulin resistance
Zinc
Myo-inositol

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Pediatric Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Zinc
Inositol
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Vitamins