The Study Aims to Investigate the Effects of Oral Inositols on Insulin-resistance in Children With Obesity.

NCT05701813 | Unknown

• 1 other identifier: CESC 65739
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study aims to investigate the effects of oral inositols on insulin-resistance and metabolic variables (triglycerides, total cholesterol, HDL cholesterol) in children aged 8-12 years with obesity and insulin-resistance.

Conditions

Obesity; Prediabetic State; Dyslipidemias; Insulin Resistance

Keywords

INOSITOLS

Outcome Measures

Primary Outcomes (1)

• Efficacy on insulin-resistance, measured with the HOMA-IR index

  Difference in HOMA-IR index change across arms

  90 days

Secondary Outcomes (1)

• Improvements in triglycerides, total cholesterol and HDL cholesterol.

  90 days

Other Outcomes (1)

• Effect on BMI (Body Mass Index)

  90 days

Study Arms (2)

INOSITOLS

EXPERIMENTAL

4000 mg of myo-inositol and 300 mg of D-chiro-inositol. Once a day for 90 days.

Dietary Supplement: INOSITOLS

PLACEBO

PLACEBO COMPARATOR

Cellulose 4.3 grams once a day for 90 days.

Dietary Supplement: CELLULOSE

Interventions

INOSITOLS DIETARY_SUPPLEMENT

4000 mg of myo-inositol and 300 mg of D-chiro-inositol. Once a day for 90 days.

INOSITOLS

CELLULOSE DIETARY_SUPPLEMENT

4.3 grams of cellulose once a day for 90 days.

PLACEBO

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age under 12 and over 8 years
• Presence of obesity defined by BMI \> 95th percentile of BMI based on the growth curves of the Italian Society of Pediatric Endocrinology and Diabetology (Cacciari curves)
• Presence of HOMA-IR value (insulin x glycaemia/22.5: marker of insulin resistance) \> 75th percentile of a reference pediatric population from Verona

You may not qualify if:

• Diabetes mellitus
• Current chronic disease with systemic inflammation
• Use of drugs acting on insulin sensitivity (e.g. steroids)
• Use of food or vitamin supplements up to one month before blood sampling
• Puberty in progress

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Related Publications (17)

• Chatree S, Thongmaen N, Tantivejkul K, Sitticharoon C, Vucenik I. Role of Inositols and Inositol Phosphates in Energy Metabolism. Molecules. 2020 Nov 1;25(21):5079. doi: 10.3390/molecules25215079.

  PMID: 33139672 BACKGROUND

• Shokrpour M, Foroozanfard F, Afshar Ebrahimi F, Vahedpoor Z, Aghadavod E, Ghaderi A, Asemi Z. Comparison of myo-inositol and metformin on glycemic control, lipid profiles, and gene expression related to insulin and lipid metabolism in women with polycystic ovary syndrome: a randomized controlled clinical trial. Gynecol Endocrinol. 2019 May;35(5):406-411. doi: 10.1080/09513590.2018.1540570. Epub 2019 Jan 4.

  PMID: 30608001 BACKGROUND

• Fruzzetti F, Perini D, Russo M, Bucci F, Gadducci A. Comparison of two insulin sensitizers, metformin and myo-inositol, in women with polycystic ovary syndrome (PCOS). Gynecol Endocrinol. 2017 Jan;33(1):39-42. doi: 10.1080/09513590.2016.1236078. Epub 2016 Nov 3.

  PMID: 27808588 BACKGROUND

• Pizzo A, Lagana AS, Barbaro L. Comparison between effects of myo-inositol and D-chiro-inositol on ovarian function and metabolic factors in women with PCOS. Gynecol Endocrinol. 2014 Mar;30(3):205-8. doi: 10.3109/09513590.2013.860120. Epub 2013 Dec 19.

  PMID: 24351072 BACKGROUND

• Kachhawa G, Senthil Kumar KV, Kulshrestha V, Khadgawat R, Mahey R, Bhatla N. Efficacy of myo-inositol and d-chiro-inositol combination on menstrual cycle regulation and improving insulin resistance in young women with polycystic ovary syndrome: A randomized open-label study. Int J Gynaecol Obstet. 2022 Aug;158(2):278-284. doi: 10.1002/ijgo.13971. Epub 2021 Nov 10.

  PMID: 34624138 BACKGROUND

• Bahadur A, Arora H, Ravi AK, Naithani M, Bahurupi Y, Chaturvedi J, Ajmani M, Mundhra R. Comparison of Clinical, Metabolic and Hormonal Effects of Metformin Versus Combined Therapy of Metformin With Myoinositol Plus D-Chiro-Inositol in Women With Polycystic Ovary Syndrome (PCOS): A Randomized Controlled Trial. Cureus. 2021 Jun 7;13(6):e15510. doi: 10.7759/cureus.15510. eCollection 2021 Jun.

  PMID: 34268040 BACKGROUND

• Maffeis C, Morandi A. Body composition and insulin resistance in children. Eur J Clin Nutr. 2018 Sep;72(9):1239-1245. doi: 10.1038/s41430-018-0239-2. Epub 2018 Sep 5.

  PMID: 30185840 BACKGROUND

• Rajjo T, Mohammed K, Alsawas M, Ahmed AT, Farah W, Asi N, Almasri J, Prokop LJ, Murad MH. Treatment of Pediatric Obesity: An Umbrella Systematic Review. J Clin Endocrinol Metab. 2017 Mar 1;102(3):763-775. doi: 10.1210/jc.2016-2574.

  PMID: 28359101 BACKGROUND

• Hayes AJ, Carrello JP, Kelly PJ, Killedar A, Baur LA. Looking backwards and forwards: tracking and persistence of weight status between early childhood and adolescence. Int J Obes (Lond). 2021 Apr;45(4):870-878. doi: 10.1038/s41366-021-00751-3. Epub 2021 Feb 8.

  PMID: 33558641 BACKGROUND

• Elks CE, den Hoed M, Zhao JH, Sharp SJ, Wareham NJ, Loos RJ, Ong KK. Variability in the heritability of body mass index: a systematic review and meta-regression. Front Endocrinol (Lausanne). 2012 Feb 28;3:29. doi: 10.3389/fendo.2012.00029. eCollection 2012.

  PMID: 22645519 BACKGROUND

• Llewellyn C, Wardle J. Behavioral susceptibility to obesity: Gene-environment interplay in the development of weight. Physiol Behav. 2015 Dec 1;152(Pt B):494-501. doi: 10.1016/j.physbeh.2015.07.006. Epub 2015 Jul 10.

  PMID: 26166156 BACKGROUND

• Silventoinen K, Jelenkovic A, Sund R, Yokoyama Y, Hur YM, Cozen W, Hwang AE, Mack TM, Honda C, Inui F, Iwatani Y, Watanabe M, Tomizawa R, Pietilainen KH, Rissanen A, Siribaddana SH, Hotopf M, Sumathipala A, Rijsdijk F, Tan Q, Zhang D, Pang Z, Piirtola M, Aaltonen S, Oncel SY, Aliev F, Rebato E, Hjelmborg JB, Christensen K, Skytthe A, Kyvik KO, Silberg JL, Eaves LJ, Cutler TL, Ordonana JR, Sanchez-Romera JF, Colodro-Conde L, Song YM, Yang S, Lee K, Franz CE, Kremen WS, Lyons MJ, Busjahn A, Nelson TL, Whitfield KE, Kandler C, Jang KL, Gatz M, Butler DA, Stazi MA, Fagnani C, D'Ippolito C, Duncan GE, Buchwald D, Martin NG, Medland SE, Montgomery GW, Jeong HU, Swan GE, Krasnow R, Magnusson PK, Pedersen NL, Dahl Aslan AK, McAdams TA, Eley TC, Gregory AM, Tynelius P, Baker LA, Tuvblad C, Bayasgalan G, Narandalai D, Spector TD, Mangino M, Lachance G, Burt SA, Klump KL, Harris JR, Brandt I, Nilsen TS, Krueger RF, McGue M, Pahlen S, Corley RP, Huibregtse BM, Bartels M, van Beijsterveldt CE, Willemsen G, Goldberg JH, Rasmussen F, Tarnoki AD, Tarnoki DL, Derom CA, Vlietinck RF, Loos RJ, Hopper JL, Sung J, Maes HH, Turkheimer E, Boomsma DI, Sorensen TI, Kaprio J. Differences in genetic and environmental variation in adult BMI by sex, age, time period, and region: an individual-based pooled analysis of 40 twin cohorts. Am J Clin Nutr. 2017 Aug;106(2):457-466. doi: 10.3945/ajcn.117.153643. Epub 2017 Jul 5.

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MeSH Terms

Conditions

Obesity; Prediabetic State; Dyslipidemias; Insulin Resistance

Interventions

Cellulose

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation is performed by the nutraceutical supplier. Neither the participant, nor the investigator, nor the care provider, nor the outcome analyzer knows which arm the patient is assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.ssa

Model Details: The children will be randomized into two arms, receiving either a mixture of inositols or placebo, for a period of 3 months.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: January 27, 2023
• Study Start: February 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share