Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism
Belgium124 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* History of bariatric surgery
* Use of analgesics, alcohol, immunosuppressive drugs or smoking 48 hours prior to study participation
* Classified as diabetic according to the American Diabetes criteria: fasting blood glucose ≥ 126 mg/dl, blood HbA1c ≥ 6.5%, or 2-hour PPGR ≥ 200 mg/dl
Additionally, study participation will be postponed in case the participant donated blood \< 8 weeks before baseline and participants will be asked not to donate blood for the duration of the trial.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postprandial glycaemic response (PPGR)
Timeframe: During the first and last week of the study, for PPGR to real-life meals and standardized meals respectively, and during the second and third study visit (day 7 and day 14).