Chronic Low Back Pain Comorbidities: Unravelling Impaired Glucose Metabolism

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

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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Glucose beverage
Other intervention
This beverage is made by dissolving 75 g of glucose in 200 ml of water.
Isomaltulose beverage
Other intervention
The isomaltulose beverage consists of 75 g of isomaltulose dissolved in 200 ml of water.
Standardized breakfast
Other intervention
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.

Treatment groups

124 Participants

are divided into 2 treatment groups

Group A: Healthy controlExperimental treatment 3 interventions

Group B: Patients with CLBPExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

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

DNA methylation of IGF1/GH-axis genes

DNA methylation patterns in specific regions of 4 IGF1/GH-axis genes will be determined by whole genome bisulfite sequencing and targeted next-generation sequencing using Peripheral Blood Mononuclear Cells (PBMCs).

Time frame

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

Serum levels of IGF1/GH-axis genes

To assess the effect of differential DNA methylation in the genes of these proteins, we will measure functional protein levels in serum samples using Enzyme-Linked ImmunoSorbent Assays (ELISAs). We expect increased DNA methylation to result in lower serum protein levels.

Time frame

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

Temperature pain thresholds

Detection and pain thresholds will be determined for both warmth and cold.

Time frame

During the first study visit (day 1).

Pressure pain thresholds

Pain thresholds and temporal summation for pressure will be determined.

Time frame

During the first study visit (day 1).

Other outcomes

Pain intensity

The participants will be asked to report pain intensity during the pain threshold measurments by rating the pain on a scale from 1 to 10 with higher scores indicating more pain.

Time frame

During the pain threshold measurements performed during the baseline visit.

Rest and activity

Using a smartwatch (accelerometer), sleep and physical activity will be measured.

Time frame

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

Plasma glucose levels

Glucose levels will be measured in plasma before and after the intervention through a blood collection.

Time frame

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

HbA1c

This marker for longterm glucose metabolism will be measured once pre-intervention through a blood collection.

Time frame

This parameter will only be measured on the pre-intervention blood collection on day 7.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vrije Universiteit Brussel

Lead sponsor

Universitair Ziekenhuis Brussel

Collaborator

KU Leuven

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: