Beta-Cell - Liver Interactions in Situations of Modified Beta-Cell Function

NCT06682481 | Recruiting

• 1 other identifier: 2024-00031
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will measure blood levels of 1,5-anhydroglucitol in obese children with or without type 2 diabetes and correlate them with parameters related to functional beta-cell mass and glucose metabolism. The values will be compared to those obtained in healthy volunteers. The aim of the study is to test the validity of 1,5-anhydroglucitol as a novel biomarker of beta-cell mass and function in children with obesity with or without type 2 diabetes.

Conditions

Obesity, Childhood; Type 2 Diabetes Mellitus in Obese

Outcome Measures

Primary Outcomes (2)

• Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control

  Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints

  First oral glucose tolerance test

• Correlation of 1,5-anhydroglucitol levels in obese children with indirect markers of beta-cell function and mass and with metabolic control

  Blood levels of 1,5-anhydroglucitol will be correlated with indirect markers of beta-cell function at 2 timepoints

  Second oral glucose tolerance test, 2 years after the first

Secondary Outcomes (2)

• Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis

  First oral glucose tolerance test

• Blood levels of 1,5-anhydroglucitol will be correlated with indicators of the liver function at different moments after diagnosis

  Second oral glucose tolerance test, 2 years after the first

Study Arms (1)

Children with obesity

Children with obesity followed within the pediatric endocrine and diabetes unit of the University Hospitals of Geneva, Switzerland. The investigators will do prospective measures in 50 children aged 12 to 15 years, at the time of a planned oral glucose tolerance test and again, 2 years later.

Other: Measurement of biomarker

Interventions

Measurement of biomarker OTHER

Measurement of blood levels of 1,5-anhydroglucitol

Children with obesity

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

50 obese children aged 12 to 16 years who have a normal or altered glucose metabolism.

You may qualify if:

• Children aged 12 to 16 years
• Obesity. Defined as a body-mass index above the 97th percentile.
• Ability to give informed consent as documented by signature

You may not qualify if:

• Patients with diabetes mellitus and positive autoantibodies against islets, insulin, islet antigen 2, glutamic acid decarboxylase or Zinc transporter 8.
• Patients with known liver disease (other than NAFLD)
• Patients treated with a drug known to affect liver function

Sponsors & Collaborators

• Philippe Klee, MD-PhD: lead
• University of Geneva, Switzerland: collaborator

Study Sites (1)

University Hospital of Geneva

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Philippe Klee

CONTACT

+41 79 55 33 476; philippe.klee@unige.ch

Pierre Maechler

CONTACT

pierre.maechler@unige.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: November 12, 2024
• Study Start: November 22, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

CH (1)