ObesityONIRICONCT05701813
The Study Aims to Investigate the Effects of Oral Inositols on Insulin-resistance in Children With Obesity.
A study testing INOSITOLS and CELLULOSE in people with Obesity and Prediabetic State, run by Azienda Ospedaliera Universitaria Integrata Verona.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Obesity, Prediabetic State, Dyslipidemias
- What is being tested?
- INOSITOLS and CELLULOSE
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effects of Inositols on Insulin Resistance in Children With Obesity (ONIRICO Trial)
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.
Read the detailed description
Insulin-resistance is a condition, frequently related to obesity, that leads to cardio-metabolic complications in both children and adults, such as type 2 diabetes, hypertension, dyslipidemia and NAFLD. The best method to lower insulin-resistance is losing weight and doing physical activity, however changing lifestyle statistically reduces excess weight mildly. Also the genetic predisposition for a positive caloric balance, the difficulty in doing physical activity regularly and the metabolic and neuroendocrine responses aimed at preserving energy make it difficult to lose weight and/or improve one's insulin sensitivity. Infact, 80% of children chronicize their obesity into adulthood. For this reason, treatment should be based on both lifestyle changes and complementary approaches. Nutraceuticals can regulate physiological functions and are ideal candidates for children, since they are highly tolerated.
Myo-inositol and D-chiro-inositol are stereoisomers of sugar which, in combination with diacylglycerol (DAG), produce phosphatidylinositol (PI), precursor in the signalling of insulin and other hormones (growth factors and FSH). The insulin receptors leads to PI phosphorylation in PIP3, which activates kinases, such as Akt, that cause nuclear (cell proliferation) and cytoplasmatic (activation of glycogen synthetase) effetcs. It also activates phospholipase C, which hydrolyses PIP2 into DAG and IP3. IP3 leads to calcium liberation and moves GLUT4 to the surface of the cell membrane.
Inositols are also precursors of inositol-6 phosphate, which is important to promote adipocytes differentiation and fat oxidation.
Level A evidence shows that dietary supplements with one or both inositols used in women with PCOS to improve ovarian function, are highly effective also on insulin-sensitivity.
The aim of this study is to compare the efficacy of inositols versus placebo on insulin-resistance, measured with the HOMA-IR index, in a sample of children with obesity. As a secondary outcome, the study aims to enlight potential improvements in triglycerides, total cholesterol and HDL cholesterol.
This is a randomized, double-blind trial involving 56 children with obesity, aged 8 to 12 years, with insulin-resistance. The children will be randomized into two groups, receiving either a mixture of inositols or placebo, for a period of 3 months (90 days). During these 3 months, the children will be evaluated twice by dietitians (on day 45 and on day 90). Glucose, insulin and lipid profile will be assessed 0 to 30 days before the study beginning and at day 90 of the treatment period. During the visits, dietitians will take the anthropometric measurements, review the lifestyle goals and verify if the treatment is followed correctly (no more than one missed intake per week).
The mixture of inositols used contains 4000 mg of myo-inositol and 300 mg of D-chiro-inositol. The chosen dosages are based on two italian studies on young women with PCOS, where it's shown their effectiveness on matabolic risk factors and their high toerance. No dosage variation is required for the trial, since the weight of the evalueted children is similar to adults weight and there aren't differences in the clearance of the supplement. Side effects are rare (<1/1000) and mild (bloating, nausea and stomach ache).
The difference in the pre-post treatment HOMA-IR and lipids changes between the two arms will be analyzed with the Student t Test for independent samples, presuming a gaussian distribution of the variable changes. The expected change difference between arms considered clinically significant and used to calculate the arm size is at least 1 standard deviation. The supplement will be considered tollerable if the frequency of side effects will be not significantly different between the two arms.
- Conditions
- Obesity, Prediabetic State, Dyslipidemias, Insulin Resistance
- Being tested
- INOSITOLS, CELLULOSE
- Keywords
- INOSITOLS
- Medical subject headings
- Obesity, Prediabetic State, Dyslipidemias, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INOSITOLSDietary supplement
4000 mg of myo-inositol and 300 mg of D-chiro-inositol. Once a day for 90 days.
CELLULOSEDietary supplement
4.3 grams of cellulose once a day for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| INOSITOLS | Experimental | 4000 mg of myo-inositol and 300 mg of D-chiro-inositol. Once a day for 90 days. Receives: Dietary Supplement: INOSITOLS |
| PLACEBO | Placebo comparator | Cellulose 4.3 grams once a day for 90 days. Receives: Dietary Supplement: CELLULOSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy on insulin-resistance, measured with the HOMA-IR index
Difference in HOMA-IR index change across arms
Measured: 90 days
Secondary outcomes (1)
Improvements in triglycerides, total cholesterol and HDL cholesterol.
Difference in changes of metabolic variables over time across arms
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The children will be randomized into two arms, receiving either a mixture of inositols or placebo, for a period of 3 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anita Morandi, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701813
- Sponsor's protocol ID
- CESC 65739
- Acronym
- ONIRICO
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33139672Shokrpour 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.
PubMed 30608001Fruzzetti 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.
PubMed 27808588Pizzo 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.
PubMed 24351072Kachhawa 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.
PubMed 34624138Bahadur 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.
PubMed 34268040Maffeis 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.
PubMed 30185840Rajjo 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.
PubMed 28359101Hayes 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.
PubMed 33558641Elks 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.
PubMed 22645519Llewellyn 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.
PubMed 26166156Silventoinen 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.
PubMed 28679550Roth CL, Melhorn SJ, De Leon MRB, Rowland MG, Elfers CT, Huang A, Saelens BE, Schur EA. Impaired Brain Satiety Responses After Weight Loss in Children With Obesity. J Clin Endocrinol Metab. 2022 Jul 14;107(8):2254-2266. doi: 10.1210/clinem/dgac299.
PubMed 35544121Fernandez 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.
PubMed 27858223Cacciari E, Milani S, Balsamo A, Spada E, Bona G, Cavallo L, Cerutti F, Gargantini L, Greggio N, Tonini G, Cicognani A. Italian cross-sectional growth charts for height, weight and BMI (2 to 20 yr). J Endocrinol Invest. 2006 Jul-Aug;29(7):581-93. doi: 10.1007/BF03344156.
PubMed 16957405
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inositols on Insulin Resistance in Children With Obesity (ONIRICO Trial)
- ClinicalTrials.gov ID
- NCT05701813
- Acronym / sponsor ID
- ONIRICO / CESC 65739
- Conditions
- Obesity, Prediabetic State, Dyslipidemias, Insulin Resistance
- Keywords
- INOSITOLS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Insulin-resistance is a condition, frequently related to obesity, that leads to cardio-metabolic complications in both children and adults, such as type 2 diabetes, hypertension, dyslipidemia and NAFLD. The best method to lower insulin-resistance is losing weight and doing physical activity, however changing lifestyle statistically reduces excess weight mildly. Also the genetic predisposition for a positive caloric balance, the difficulty in doing physical activity regularly and the metabolic and neuroendocrine responses aimed at preserving energy make it difficult to lose weight and/or improve one's insulin sensitivity. Infact, 80% of children chronicize their obesity into adulthood. For this reason, treatment should be based on both lifestyle changes and complementary approaches. Nutraceuticals can regulate physiological functions and are ideal candidates for children, since they are highly tolerated.
Myo-inositol and D-chiro-inositol are stereoisomers of sugar which, in combination with diacylglycerol (DAG), produce phosphatidylinositol (PI), precursor in the signalling of insulin and other hormones (growth factors and FSH). The insulin receptors leads to PI phosphorylation in PIP3, which activates kinases, such as Akt, that cause nuclear (cell proliferation) and cytoplasmatic (activation of glycogen synthetase) effetcs. It also activates phospholipase C, which hydrolyses PIP2 into DAG and IP3. IP3 leads to calcium liberation and moves GLUT4 to the surface of the cell membrane.
Inositols are also precursors of inositol-6 phosphate, which is important to promote adipocytes differentiation and fat oxidation.
Level A evidence shows that dietary supplements with one or both inositols used in women with PCOS to improve ovarian function, are highly effective also on insulin-sensitivity.
The aim of this study is to compare the efficacy of inositols versus placebo on insulin-resistance, measured with the HOMA-IR index, in a sample of children with obesity. As a secondary outcome, the study aims to enlight potential improvements in triglycerides, total cholesterol and HDL cholesterol.
This is a randomized, double-blind trial involving 56 children with obesity, aged 8 to 12 years, with insulin-resistance. The children will be randomized into two groups, receiving either a mixture of inositols or placebo, for a period of 3 months (90 days). During these 3 months, the children will be evaluated twice by dietitians (on day 45 and on day 90). Glucose, insulin and lipid profile will be assessed 0 to 30 days before the study beginning and at day 90 of the treatment period. During the visits, dietitians will take the anthropometric measurements, review the lifestyle goals and verify if the treatment is followed correctly (no more than one missed intake per week).
The mixture of inositols used contains 4000 mg of myo-inositol and 300 mg of D-chiro-inositol. The chosen dosages are based on two italian studies on young women with PCOS, where it's shown their effectiveness on matabolic risk factors and their high toerance. No dosage variation is required for the trial, since the weight of the evalueted children is similar to adults weight and there aren't differences in the clearance of the supplement. Side effects are rare (<1/1000) and mild (bloating, nausea and stomach ache).
The difference in the pre-post treatment HOMA-IR and lipids changes between the two arms will be analyzed with the Student t Test for independent samples, presuming a gaussian distribution of the variable changes. The expected change difference between arms considered clinically significant and used to calculate the arm size is at least 1 standard deviation. The supplement will be considered tollerable if the frequency of side effects will be not significantly different between the two arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The children will be randomized into two arms, receiving either a mixture of inositols or placebo, for a period of 3 months.
| Arm | Type | Receives |
|---|---|---|
| INOSITOLS | Experimental | Dietary Supplement: INOSITOLS4000 mg of myo-inositol and 300 mg of D-chiro-inositol. Once a day for 90 days. |
| PLACEBO | Placebo comparator | Dietary Supplement: CELLULOSECellulose 4.3 grams once a day for 90 days. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INOSITOLS4000 mg of myo-inositol and 300 mg of D-chiro-inositol. Once a day for 90 days. | Dietary supplement | INOSITOLS |
| CELLULOSE4.3 grams of cellulose once a day for 90 days. | Dietary supplement | PLACEBO |
Primary outcome
Efficacy on insulin-resistance, measured with the HOMA-IR index
Time frame: 90 days
Difference in HOMA-IR index change across arms
1 secondary outcome
Improvements in triglycerides, total cholesterol and HDL cholesterol.
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
- Background: PubMed 33139672Chatree 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.
- Background: PubMed 30608001Shokrpour 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.
- Background: PubMed 27808588Fruzzetti 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.
- Background: PubMed 24351072Pizzo 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.
- Background: PubMed 34624138Kachhawa 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.
- Background: PubMed 34268040Bahadur 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.
- Background: PubMed 30185840Maffeis 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.
- Background: PubMed 28359101Rajjo 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.
- Background: PubMed 33558641Hayes 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.
- Background: PubMed 22645519Elks 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.
- Background: PubMed 26166156Llewellyn 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.
- Background: PubMed 28679550Silventoinen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing INOSITOLS and CELLULOSE in people with Obesity and Prediabetic State, run by Azienda Ospedaliera Universitaria Integrata Verona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy on insulin-resistance, measured with the HOMA-IR index (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05701813, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.