Prevalence of IR in Overweight and Obese Adolescents

NCT05810883 | Unknown DMC

• 1 other identifier: IR in Overweight Adolescents
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Identifying Risk Factors for Insulin Resistance in each group

  Baseline

Study Arms (2)

Insulin Resistant Group

HOMA-IR score of ≥ 3.4

Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose

Non-Insulin Resistant

HOMA-IR score of less than 3.4

Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose

Interventions

Blood Tests; Serum Fasting Insulin and Glucose DIAGNOSTIC_TEST

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

Also known as: Anthropometric Measurements including BMI and Waist circumference

Insulin Resistant Group; Non-Insulin Resistant

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Adolescent Children attending Hospital or Primary care clinics in Egypt whom fit the criteria.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (14)

• 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.

  PMID: 29280741 BACKGROUND

• 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.

  PMID: 25703114 BACKGROUND

• 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.

  PMID: 20861173 BACKGROUND

• 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.

  PMID: 24016455 BACKGROUND

• 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.

  PMID: 27417770 BACKGROUND

• 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.

  PMID: 17167471 BACKGROUND

• 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.

  PMID: 20829185 BACKGROUND

• 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.

  PMID: 21274322 BACKGROUND

• 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.

  PMID: 26273668 BACKGROUND

• 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.

  PMID: 27984205 BACKGROUND

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

  PMID: 11679420 BACKGROUND

• 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.

  PMID: 10512371 BACKGROUND

• 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.

  PMID: 27824069 BACKGROUND

• 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.

  PMID: 24243989 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood tests include Serum Fasting Insulin and Serum Blood Glucose, along with lipid profile

MeSH Terms

Conditions

Insulin Resistance

Interventions

Hematologic Tests; Waist Circumference

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Anthropometry; Physiological Phenomena

Central Study Contacts

Yara Mostafa, MBBS

CONTACT

+201064883673; yaramostafa9595@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Resident Physician

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 13, 2023
• Study Start: May 11, 2023
• Primary Completion: February 1, 2024
• Study Completion: August 30, 2025
• Last Updated: April 28, 2023

Record last verified: 2023-04