Prevalence of IR in Overweight and Obese Adolescents

NCT ID: NCT05810883

Last Updated: 2023-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-11

Study Completion Date

2025-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Insulin Resistant Group

HOMA-IR score of ≥ 3.4

Blood Tests; Serum Fasting Insulin and Glucose

Intervention Type 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

Non-Insulin Resistant

HOMA-IR score of less than 3.4

Blood Tests; Serum Fasting Insulin and Glucose

Intervention Type 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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Anthropometric Measurements including BMI and Waist circumference

Eligibility Criteria

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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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Yara Mostafa

Pediatric Resident Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yara Mostafa, MBBS

Role: CONTACT

+201064883673

References

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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.

Reference Type BACKGROUND
PMID: 29280741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25703114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20861173 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24016455 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27417770 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17167471 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20829185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21274322 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26273668 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27984205 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 11679420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10512371 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27824069 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24243989 (View on PubMed)

Other Identifiers

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IR in Overweight Adolescents

Identifier Type: -

Identifier Source: org_study_id

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