Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss

Registration

Registration

NCT07592546

Acronym

THRIVE

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE4

Masking

NONE

Status

NOT_YET_RECRUITING

Enrollment

240

Start

2026-08-01

Primary completion

2028-12-01

Lead sponsor

Alain Dagher

Conditions

Class I/II Obesity

Interventions

DRUG:semaglutide

Results posted

FALSE

Individual participant data sharing

YES

Registered primary outcomes

• Serum C-reactive Protein (CRP) [Baseline & Change from Baseline]
• Serum Pro-inflammatory Cytokines (Interleukin-6, TNF-α, Interleukin-1β, and IL-1 Receptor Antagonist) [Baseline & Change from Baseline]
• Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [Baseline & Change from Baseline]
• Fasting Plasma Glucose [Baseline & Change from Baseline]
• Glycated Hemoglobin A1c (HbA1c) [Baseline & Change from Baseline]
• Serum Leptin [Baseline & Change from Baseline]
• Serum Ghrelin [Baseline & Change from Baseline]
• Serum Adiponectin [Baseline & Change from Baseline]
• Fasting Serum Insulin [Baseline & Change from Baseline]
• Serum Glucagon-Like Peptide-1 (GLP-1) [Baseline & Change from Baseline]
• Serum C-peptide [Baseline & Change from Baseline]
• Serum Lipid Panel (Total Cholesterol, HDL Cholesterol, LDL Cholesterol, Triglycerides, and Non-Esterified Fatty Acids [NEFA]) [Baseline & Change from Baseline]
• Serum Apolipoprotein B (ApoB) [Baseline & Change from Baseline]
• Red Blood Cell Phospholipid Fatty Acid Composition [Baseline & Change from Baseline]
• Cerebral Blood Flow as Measured by Pseudo-Continuous Arterial Spin Labeling (pCASL) MRI [Baseline & Change from Baseline]
• Oxygen Extraction Fraction (OEF) as Measured by Quantitative Susceptibility Mapping (QSM) and T2* MRI [Baseline & Change from Baseline]
• Cerebral Metabolic Rate of Oxygen (CMRO₂) as Measured by QSM and T2* MRI [Baseline & Change from Baseline]
• Cortical Thickness as Measured by Structural MRI [Baseline & Change from Baseline]
• Grey Matter Volume as Measured by Structural MRI [Baseline & Change from Baseline]
• Grey Matter Surface Area as Measured by Structural MRI [Baseline & Change from Baseline]
• White Matter Fractional Anisotropy (FA) as Measured by Diffusion Tensor Imaging (DTI) [Baseline & Change from Baseline]
• White Matter Mean Diffusivity (MD) as Measured by Diffusion Tensor Imaging (DTI) [Baseline & Change from Baseline]
• White Matter Microstructure as Measured by NODDI (intracellular volume fraction [ICVF], isotropic volume fraction [ISOVF], and Orientation Dispersion Index [ODI]) [Baseline & Change from Baseline]
• White Matter Hyperintensity Volume as Measured by FLAIR MRI [Baseline & Change from Baseline]
• Cerebrovascular Reactivity (CVR) as Measured by BOLD fMRI with End-Tidal CO₂ (EtCO₂) Challenge [Baseline & Change from Baseline]
• Neuroinflammation proxy as Measured by T2* relaxation times [Baseline & Change from Baseline]
• Neuromelanin Contrast Ratio in the Substantia Nigra as Measured by Neuromelanin-Sensitive MRI [Baseline & Change from Baseline]
• Intracranial Artery Lumen Diameter as Measured by Time-of-Flight MRA [Baseline & Change from Baseline]
• Body Mass Index (BMI) [Baseline & Change from Baseline]
• Waist Circumference, Hip Circumference [Baseline & Change from Baseline]
• Waist-to-height ratio, Waist-to-hip ratio [Baseline & Change from Baseline]
• Visceral Adipose Tissue as Measured by MRI [Baseline & Change from Baseline]
• Subcutaneous Adipose Tissue as Measured by MRI [Baseline & Change from Baseline]
• Body Composition [Baseline & Change from Baseline]