Prevalence of IR in Overweight and Obese Adolescents

Insulin Resistance Clinical Trial

— IR  

Official title:

Prevalence and Risk Factors of Insulin Resistance in Overweight and Obese Adolescents

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05810883
• Other study ID #: IR in Overweight Adolescents
• Status: Not yet recruiting
• Start date: May 11, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2023
• Source: Assiut University
• Contact: Yara Mostafa, MBBS
• Phone: +201064883673
• Email: yaramostafa9595[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine the prevalence of Insulin Resistance (IR) among overweight and obese adolescents using HOMA-IR scores and identify lifestyle risk factors in the IR and Non-IR group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 30, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Adolescents of ages = 10-=18 years, of both sexes who are Overweight (BMI > 85th percentile) or Obese (BMI > 95th percentile).

Exclusion Criteria:

• Obesity due to Secondary causes as Cushing disease or hypothyroid patients, and any other patients with Chronic illness.

Related Conditions & MeSH terms

• Insulin Resistance
• Overweight

Intervention

Diagnostic Test:
• Blood Tests; Serum Fasting Insulin and Glucose
Laboratory results of blood samples, for high-density lipoprotein (HDL), low-density protein (LDL), triglycerides, and total cholesterol (TC) will be evaluated for this study. Fasting Insulin and fasting glucose levels will be used to calculate IR. Insulin Resistance will be calculated using Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (FPG (mmol/L) × FPI (mU/L)/22.5) [21] and defined as HOMA-IR = 3.4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (14)

de Onis M, Blossner M, Borghi E. Global prevalence and trends of overweight and obesity among preschool children. Am J Clin Nutr. 2010 Nov;92(5):1257-64. doi: 10.3945/ajcn.2010.29786. Epub 2010 Sep 22. — View Citation

Goran MI, Gower BA. Longitudinal study on pubertal insulin resistance. Diabetes. 2001 Nov;50(11):2444-50. doi: 10.2337/diabetes.50.11.2444. — View Citation

Govers E. Obesity and Insulin Resistance Are the Central Issues in Prevention of and Care for Comorbidities. Healthcare (Basel). 2015 Jun 4;3(2):408-16. doi: 10.3390/healthcare3020408. — View Citation

Ighbariya A, Weiss R. Insulin Resistance, Prediabetes, Metabolic Syndrome: What Should Every Pediatrician Know? J Clin Res Pediatr Endocrinol. 2017 Dec 30;9(Suppl 2):49-57. doi: 10.4274/jcrpe.2017.S005. Epub 2017 Dec 27. — View Citation

Kahn SE, Hull RL, Utzschneider KM. Mechanisms linking obesity to insulin resistance and type 2 diabetes. Nature. 2006 Dec 14;444(7121):840-6. doi: 10.1038/nature05482. — View Citation

Kelly AS, Barlow SE, Rao G, Inge TH, Hayman LL, Steinberger J, Urbina EM, Ewing LJ, Daniels SR; American Heart Association Atherosclerosis, Hypertension, and Obesity in the Young Committee of the Council on Cardiovascular Disease in the Young, Council on Nutrition, Physical Activity and Metabolism, and Council on Clinical Cardiology. Severe obesity in children and adolescents: identification, associated health risks, and treatment approaches: a scientific statement from the American Heart Association. Circulation. 2013 Oct 8;128(15):1689-712. doi: 10.1161/CIR.0b013e3182a5cfb3. Epub 2013 Sep 9. — View Citation

Kurtoglu S, Hatipoglu N, Mazicioglu M, Kendirici M, Keskin M, Kondolot M. Insulin resistance in obese children and adolescents: HOMA-IR cut-off levels in the prepubertal and pubertal periods. J Clin Res Pediatr Endocrinol. 2010;2(3):100-6. doi: 10.4274/jcrpe.v2i3.100. Epub 2010 Aug 2. — View Citation

Levy-Marchal C, Arslanian S, Cutfield W, Sinaiko A, Druet C, Marcovecchio ML, Chiarelli F; ESPE-LWPES-ISPAD-APPES-APEG-SLEP-JSPE; Insulin Resistance in Children Consensus Conference Group. Insulin resistance in children: consensus, perspective, and future directions. J Clin Endocrinol Metab. 2010 Dec;95(12):5189-98. doi: 10.1210/jc.2010-1047. Epub 2010 Sep 8. — View Citation

Ling JC, Mohamed MN, Jalaludin MY, Rampal S, Zaharan NL, Mohamed Z. Determinants of High Fasting Insulin and Insulin Resistance Among Overweight/Obese Adolescents. Sci Rep. 2016 Nov 8;6:36270. doi: 10.1038/srep36270. — View Citation

Lobstein T, Jackson-Leach R, Moodie ML, Hall KD, Gortmaker SL, Swinburn BA, James WP, Wang Y, McPherson K. Child and adolescent obesity: part of a bigger picture. Lancet. 2015 Jun 20;385(9986):2510-20. doi: 10.1016/S0140-6736(14)61746-3. Epub 2015 Feb 19. — View Citation

Moran A, Jacobs DR Jr, Steinberger J, Hong CP, Prineas R, Luepker R, Sinaiko AR. Insulin resistance during puberty: results from clamp studies in 357 children. Diabetes. 1999 Oct;48(10):2039-44. doi: 10.2337/diabetes.48.10.2039. — View Citation

van der Aa MP, Fazeli Farsani S, Knibbe CA, de Boer A, van der Vorst MM. Population-Based Studies on the Epidemiology of Insulin Resistance in Children. J Diabetes Res. 2015;2015:362375. doi: 10.1155/2015/362375. Epub 2015 Jul 27. — View Citation

van der Aa MP, Fazeli Farsani S, Kromwijk LA, de Boer A, Knibbe CA, van der Vorst MM. How to screen obese children at risk for type 2 diabetes mellitus? Clin Pediatr (Phila). 2014 Apr;53(4):337-42. doi: 10.1177/0009922813509480. Epub 2013 Nov 14. — View Citation

van der Aa MP, Knibbe CA, Boer A, van der Vorst MM. Definition of insulin resistance affects prevalence rate in pediatric patients: a systematic review and call for consensus. J Pediatr Endocrinol Metab. 2017 Feb 1;30(2):123-131. doi: 10.1515/jpem-2016-0242. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants of the Obese or Overweight category with elevated Serum Fasting Insulin and Serum Fasting glucose scores	Measuring Serum Fasting Insulin and Fasting Glucose levels to calculate HOMA-IR scores Insulin Resistance will be calculated using Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) (Fasting Plasma Glucose (mmol/L) × Fasting Plasma Insulin (mU/L)/22.5) and defined as HOMA-IR = 3.4 to Detect Prevalence of IR, higher scores indicating increased Insulin Resistance.	Baseline
Secondary	Identifying Risk Factors for Insulin Resistance in each group	Information on each individual gathered regarding Lifestyle and Nutritional Habits including Social/Economic condition, Family History for obesity, diabetes and hypertension, perinatal history, early feeding and detailed Nutritional History; including sugar, carbohydrate and fat consumption, Physical activity, sleep quality, psychological stressors and performance at school. Data will be gathered for each group; Insulin Resistant and Non-Insulin resistance to determine associations between the two.	Baseline