Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism

Summary

Chronic low back pain (CLBP) is a global health problem. The first step for developing effective treatments is a better understanding of underlying mechanisms, including its comorbidities. Cumulative findings, including breakthrough findings from our own group, point to impaired glucose metabolism as an important CLBP comorbidity. In addition to its metabolic role, the insulin-like growth factor 1 (IGF1)/ growth hormone (GH) axis plays a key role in pain modulation. Therefore, the project aims to examine whether DNA methylation and functional protein levels predicts postprandial glycemic responses to standardized drinks, standardized meals, and real-life meals in patients with CLBP. This will be examined using two (i.e., 1 in CLBP and 1 in healthy controls) double-blind, randomized cross-over experiments (high versus low glycaemic index beverages). After the 14-day experimental phase, all participants will be studied for an additional week to examine whether the experimental findings have ecological validity, i.e., whether they can be confirmed in response to real-life meals in their home environment. Genome-wide changes in DNA methylation will be studied using whole genome bisulfite sequencing and targeted next-generation sequencing. The project allows identification of a biomarker for a potentially very significant CLBP comorbidity, including identifying targetable mechanisms to develop innovative, personalized treatments.

Conditions

• Chronic Low Back Pain (Non-specific, Uncomplicated)
• Chronic Low Back Pain (CLBP)

Interventions

OTHER

Standardized breakfast

During week 3 of the study, all partcipants consume a standardized breakfast after an overnight fast for seven days. This breakfast consists of 55g of white bread and 50g of dark chocolate. The participants are asked not to eat or perform strenuous exercise for up to two hours after consuming the breakfast.

OTHER

Glucose beverage

This beverage is made by dissolving 75 g of glucose in 200 ml of water.

OTHER

Isomaltulose beverage

The isomaltulose beverage consists of 75 g of isomaltulose dissolved in 200 ml of water.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• KU Leuven

  collaborator OTHER

• Vrije Universiteit Brussel

  lead OTHER

Principal Investigators

• Jo Nijs, Professor · Vrije Universiteit Brussel

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2030-04-30

Completion

2030-04-30

Countries

• Belgium

Study Locations