Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism
Not yet recruitingNot applicableNCT07734714
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism
- Interventions
- Other: Glucose beverage
- Other: Isomaltulose beverage
- Other: Standardized breakfast
- Sponsor
- Vrije Universiteit Brussel
- Collaborators
- Universitair Ziekenhuis Brussel; KU Leuven
- Start date
- 2026-07
- Primary completion
- 2030-04
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Belgium
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07734714