Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVrije Universiteit Brussel

About this trial

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.

Eligibility criteria

Qualifiers

Between 18 and 65 years old

For patient group: participants must comply to the non-specific CLBP criteria which are low back pain every day for three months or pain for at least half the days in the last six months, without leg pain that exceeds 7 out of 10 on a numeric rating scale and without evidence of specific spinal pathologies.

For healthy volunteers: pain-free for the entire duration of the study

Disqualifiers

Systemic diseases (e.g., hypertension, cardiovascular disease, chronic gastrointestinal disorder, skin disease, active neuropathic disorder, severe eating disorders, myocardial infarction or cerebrovascular accident in the 6 months prior to the study)

Current pregnancy or pregnancy in the last year

Start-up of new medication or (dietary) treatment in the six weeks before the study

Antibiotic use in the three months prior to the study

Trial design

Treatments tested in this trial

  • Glucose beverage
  • Isomaltulose beverage
  • Standardized breakfast

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Vrije Universiteit Brussel

Lead sponsor

Universitair Ziekenhuis Brussel

Collaborator

KU Leuven

Collaborator