Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)

Registration

Registration

NCT06967389

Acronym

MODERN

Study type

OBSERVATIONAL

Status

RECRUITING

Enrollment

50

Start

2025-06-12

Primary completion

2027-07

Lead sponsor

John Bauer

Conditions

Obesity and Overweight; Obese Adolescents; Weight Management; Weight Loss; Cardiovascular Disease Risk Factor

Interventions

DRUG:Ozempic®

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Change in medication use [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Lipid Profile [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in C-reactive protein [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Tumor necrosis factor [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Interleukin-6 [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Adiponectin [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Soluble Intercellular Adhesion Marker [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Systolic Blood pressure [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Diastolic Blood pressure [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in ambulatory blood pressure [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Cardiac structure [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Cardiac function (Ejection Fraction) [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Cardiac function (Stroke Volume (SV) [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Cardiac function (Cardiac Output (CO) [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Cardiac function (Wall motion) [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]
• Change in Cardiac function (Valve motion) [Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment]