Obesity — The Study Aims to Investigate the Effects of Oral Inositols on Insulin-resistance in Children With Obesity.
Citation(s)
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.
Fernandez I, Canet O, Gine-Garriga M Assessment of physical activity levels, fitness and perceived barriers to physical activity practice in adolescents: cross-sectional study. Eur J Pediatr. 2017 Jan;176(1):57-65. doi: 10.1007/s00431-016-2809-4. Epub 2016 Nov 17.
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.
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.
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.
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.
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.
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.
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.
World Medical Association World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053. No abstract available.
Effects of Inositols on Insulin Resistance in Children With Obesity (ONIRICO Trial)
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.