Metabolically Healthy Obese

NCT06032312 | Unknown DMC

• 1 other identifier: 0799-20-TLV
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Little is known about the associated factors and mechanisms involved in the development of metabolic disturbance in pediatric obesity. The overall objective of the present study is to investigate clinical, anthropometric, socio-demographic and lifestyle predictors of MHO among obese children and adolescents. The Aim of the present study is to investigate the effect of fat distribution, muscle mass, strength and physical activity level on metabolic morbidity in obese adolescents.

Conditions

Obesity; Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

• Body composition (fat and fat free mass) of MHO

  body fat and fat free mass of MHO will be assessed by bioelectrical impedance

  1 day

• Abdominal fat distribution using abdominal MRI

  Abdominal fat distribution will be assessed by abdominal MRI. a researchers will calculate the visceral and sub-cutanic fat volume

  3 days

• Dietary pattern in MHO

  Dietary pattern will be assessed by food frequency questioner that will asses consumption of dietary items (from once a day to less than once a month or never)

  1 day

• physical activity of MHO

  physical activity be assessed by acetometer that will a measure walk distance per day

  3 days

Study Arms (2)

1

metabolic healthy obese

Other: description

2

metabolic unhealthy obese

Other: description

Interventions

description OTHER

no intervention, just description of the groups

1; 2

Eligibility Criteria

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

Study Population

The study will be performed in the Nutrition and Obesity Clinic of the Pediatric Gastroenterology Unit at "Dana Dwek" Children's Hospital. All children and adolescents that will be admitted to our clinic between December 2020 and December 2024 will be included in the study.

You may qualify if:

• Children aged 10-18 with obesity
• Attendance of the obesity clinic in the pediatric gastroenterology unit at "Dana-Dwek" children's hospital, Tel Aviv Sourasky Medical Center.

You may not qualify if:

• Children with congenital or acquired heart disease
• Children with inflammatory conditions
• Children with neurological conditions that affect body composition

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv medical center

Tel Aviv, Israel

RECRUITING

Related Publications (1)

• Moran-Lev H, Sternfeld R, Lazmi R, Ohayon R, Dudi R, Brener A, Sagi SZ, Cohen S, Lubetzky R, Gepner Y. Hepatic fat and dietary intake as determinants of metabolic health in obese adolescents: a cross-sectional MRI study. Front Nutr. 2025 Jul 9;12:1559271. doi: 10.3389/fnut.2025.1559271. eCollection 2025.

  PMID: 40704318 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples for metabolic syndrome, abdominal MRI for liver fat

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hadar Moran Lev, MD

CONTACT

972527360713; hadarlev6@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: September 13, 2023
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)