AzTrials
AzTrials

Insulin ResistanceIRNCT05810883

Prevalence of IR in Overweight and Obese Adolescents

An observational study of Insulin Resistance, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 10 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Resistance
What is being tested?
Blood Tests; Serum Fasting Insulin and Glucose
How many people
50 participants
Where
No sites listed yet
Study dates
11 May 2023to 30 Aug 2025
Phase
Observational
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 10 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Yara Mostafa, MBBS contact

+201064883673

yaramostafa9595@gmail.com

About this study

Official title: Prevalence and Risk Factors of Insulin Resistance in Overweight and Obese Adolescents

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.

Being tested
Blood Tests; Serum Fasting Insulin and Glucose
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood Tests; Serum Fasting Insulin and GlucoseDiagnostic test

    Also called Anthropometric Measurements including BMI and Waist circumference

    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

Study groups in NCT05810883
Study groupRoleWhat they receive
Insulin Resistant GroupHOMA-IR score of ≥ 3.4
Receives: Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose
Non-Insulin ResistantHOMA-IR score of less than 3.4
Receives: Diagnostic Test: Blood Tests; Serum Fasting Insulin and Glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (1)

  1. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2023
  2. Study start11 May 2023 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion30 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05810883
Sponsor's protocol ID
IR in Overweight Adolescents
Acronym
IR
Status last verified
Apr 2023
First submitted
12 Apr 2022
Last updated
28 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29280741

  • 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.

    PubMed 25703114

  • 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.

    PubMed 20861173

  • 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.

    PubMed 24016455

  • 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.

    PubMed 27417770

  • 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.

    PubMed 17167471

  • 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.

    PubMed 20829185

  • 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.

    PubMed 21274322

  • 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.

    PubMed 26273668

  • 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.

    PubMed 27984205

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

    PubMed 11679420

  • 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.

    PubMed 10512371

  • 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.

    PubMed 27824069

  • 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.

    PubMed 24243989

Questions about this trial

What is this clinical trial studying?

An observational study of Insulin Resistance, run by Assiut University.

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 1 inclusion and 1 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 28 Apr 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. 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?

Contact Yara Mostafa, MBBS (+201064883673, yaramostafa9595@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants of the Obese or Overweight category with elevated Serum Fasting Insulin and Serum Fasting glucose scores (time frame: Baseline). 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 NCT05810883, which also lists 14 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 28 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in