Studying the Effect of Mediterranean Diet on Insulin Resistance Among Obese Children and Adolescents

NCT04313452 | Unknown DMC

• 1 other identifier: 8170598
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Insulin resistance is a common complication of childhood obesity. It is considered to be an important link between adiposity and the risk factor of type 2 diabetes in children. The lifestyle modifications, including a healthy diet, physical activity and weight reduction in obese children and adolescents have been proven effective in type 2 diabetes prevention and management. Although increasing evidence suggests that Mediterranean diet could be associated with decreased risk of metabolic syndrome, diabetes, obesity and atherosclerosis in adults. The importance of this study is to find the effect of Mediterranean diet on insulin resistance among obese children and adolescents aged 10-16 years. Additionally, the results of the present study will help health professionals particularly dietitians in directing children with insulin resistance towards adopting healthy diet and lifestyle.

Conditions

Obesity, Childhood; Insulin Resistance

Keywords

Mediterranean Diet

Outcome Measures

Primary Outcomes (2)

• Mediterranean Diet and insulin Resistance

  Mediterranean Diet change of blood level of Homa IR among Obese Children and Adolescents

  6 month

• Mediterranean Diet and body weight

  Mediterranean Diet change in body weight in kilogram among Obese Children and Adolescents

  6 month

Secondary Outcomes (1)

• Mediterranean Diet and lipid profile

  6 month

Study Arms (2)

regular diet

PLACEBO COMPARATOR

50% of energy from carbohydrates, 30% fat and 20% from protein

Other: the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged

Mediterranean diet

ACTIVE COMPARATOR

60% of energy from carbohydrates, 25% fat and 15% from protein

Other: the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged

Interventions

the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged OTHER

to find the effect of Mediterranean diet on insulin resistance among obese children and adolescents aged 10-16 years with insulin resistance compared to the regular diet

Also known as: Diet intervention

Mediterranean diet; regular diet

Eligibility Criteria

• Age: 10 Years - 16 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age range between 10-16 years.
• Obese children and adolescents, BMI for age and sex is greater than the +2rd z-score, according to WHO growth chart.
• Children and adolescents diagnosed with insulin resistance and presence of acanthosis nigricans.
• Not on medication.

You may not qualify if:

• Age younger than 10 years or older than 16 years.
• Overweight children and adolescents or obese (BMI for age and sex is less than +2rd z-score, according to WHO growth chart.
• Children and adolescents didn't diagnosis of insulin resistance
• On any medication.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan

Amman, Jordan

Location

Related Publications (5)

• Cruz ML, Weigensberg MJ, Huang TT, Ball G, Shaibi GQ, Goran MI. The metabolic syndrome in overweight Hispanic youth and the role of insulin sensitivity. J Clin Endocrinol Metab. 2004 Jan;89(1):108-13. doi: 10.1210/jc.2003-031188.

  PMID: 14715836 BACKGROUND

• Arslanian S, Kim JY, Nasr A, Bacha F, Tfayli H, Lee S, Toledo FGS. Insulin sensitivity across the lifespan from obese adolescents to obese adults with impaired glucose tolerance: Who is worse off? Pediatr Diabetes. 2018 Mar;19(2):205-211. doi: 10.1111/pedi.12562. Epub 2017 Jul 20.

  PMID: 28726334 RESULT

• Bener A. Prevalence of obesity, overweight, and underweight in Qatari adolescents. Food Nutr Bull. 2006 Mar;27(1):39-45. doi: 10.1177/156482650602700106.

  PMID: 16572718 RESULT

• Bos MB, de Vries JH, Feskens EJ, van Dijk SJ, Hoelen DW, Siebelink E, Heijligenberg R, de Groot LC. Effect of a high monounsaturated fatty acids diet and a Mediterranean diet on serum lipids and insulin sensitivity in adults with mild abdominal obesity. Nutr Metab Cardiovasc Dis. 2010 Oct;20(8):591-8. doi: 10.1016/j.numecd.2009.05.008. Epub 2009 Aug 18.

  PMID: 19692213 RESULT

• Davis C, Bryan J, Hodgson J, Murphy K. Definition of the Mediterranean Diet; a Literature Review. Nutrients. 2015 Nov 5;7(11):9139-53. doi: 10.3390/nu7115459.

  PMID: 26556369 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Insulin Resistance

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Reema F Tayyam, PHD

  University of Jordan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University of Jordan

Model Details: The study sample will consist of 50 participants of obese children and adolescents between 10 and 16 years of age who are diagnosed with insulin resistance clinically. Twenty five of participants (1:1, boys: girls) will follow Mediterranean diet, and 25 of participants (1:1, boys: girls) will follow regular diet. The two groups will be matched for age and gender. The Pediatric Endocrinologist will diagnose the children with insulin resistance clinically according to abdominal obesity and presence of acanthosis nigricans. The children and adolescents will be randomly assigned to one of the groups: Mediterranean diet group or the regular diet group.

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: March 18, 2020
• Study Start: February 27, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Patients will be followed-up every 2 weeks in the clinic for 6 months
• Access Criteria: Obese children and adolescents, BMI for age and sex is greater than the +2rd z-score, according to WHO growth chart, age between 10-16 years. Children and adolescents diagnosed with insulin resistance and presence of acanthosis nigricans and not on medication.

Locations

JO (1)