Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism

NCT07734714 | Not Yet Recruiting

• 1 other identifier: 25386_GLOW
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Epigenetic; DNA methylation; Glucose metabolism; IGF1/GH axis; Chronic low back pain; CLBP

Outcome Measures

Primary Outcomes (1)

• Postprandial glycaemic response (PPGR)

  The primary outcome measure is the postprandial glycaemic response (PPGR) following standardized drinks, standardized breakfasts and real-life meals using a continuous glucose monitor.

  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).

Secondary Outcomes (15)

• DNA methylation of IGF1/GH-axis genes

  PBMCs will be isolated after blood collection on day 7 and day 14.

• Serum levels of IGF1/GH-axis genes

  Blood collection will be done on day 7 and day 14.

• Temperature pain thresholds

  During the first study visit (day 1).

• Pressure pain thresholds

  During the first study visit (day 1).

• 36-item Short Form Health Survey (SF-36)

  This questionnaire is completed by the participants at baseline (day 1).

Other Outcomes (21)

• Pain intensity

  During the pain threshold measurements performed during the baseline visit.

• Rest and activity

  The smartwatch will be worn for the full duration of the trial (day 1 to day 21).

• Plasma glucose levels

  A blood collection is performed during the second and third study visit (day 7 and day 14).

Study Arms (2)

Healthy control

EXPERIMENTAL

The healthy controls will undergo the same assessments as the patients with CLBP, namely the high and low glycaemic index beverages. However, the healthy controls do not show signs of chronic low back pain as defined in the protocol.

Other: Glucose beverage; Other: Isomaltulose beverage; Other: Standardized breakfast

Patients with CLBP

EXPERIMENTAL

Patients with CLBP will undergo the same assessments as the healthy control group, namely the high and low glycaemic index beverages. CLBP is defined as experiencing low back pain every day for at least 3 months, or every other day for at least 6 months.

Other: Glucose beverage; Other: Isomaltulose beverage; Other: Standardized breakfast

Interventions

Glucose beverage OTHER

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

Healthy control; Patients with CLBP

Isomaltulose beverage OTHER

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

Healthy control; Patients with CLBP

Standardized breakfast OTHER

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.

Healthy control; Patients with CLBP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: All genders, including transgender in absence of hormone therapy or surgery, can be included in this study if they meet the eligibility criteria. Due to hormonal effects on the glucose metabolism and other outcome measures, transgender people having undergone hormonal therapy and/or surgery will not be included in this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead
• Universitair Ziekenhuis Brussel: collaborator
• KU Leuven: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Links

• The study website with a summary of the study and contact information.

Study Officials

• Jo Nijs, Professor

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joni Michiels, PhD student

CONTACT

+32471103990; Joni.Michiels2@vub.be

Jinane Ben Amar, PhD student

CONTACT

+32487219246; Jinane.Ben.Amar@vub.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 29, 2026

Record last verified: 2026-06

Locations

BE (1)