Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection (Cr)

November 26, 2024 updated by: Mohamed Ahmed Hamed, Fayoum University

Does Oral Chromium Withstand Steroid Hyperglycemia in Post-interventional Ultrasound Guided Sacroiliac Joint Injection in Diabetic Patients

The aim of this study is to investigate whether oral chromium supplementation can decrease steroid-induced hyperglycemia in diabetic patients undergoing ultrasound-guided sacroiliac joint injections through a randomized controlled trial (RCT).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

One of the most prevalent complaints these days is sacroiliitis, which affects around 20% of the population.

In roughly 10% to 27% of these cases, the sacroiliac joint has been identified as the major source of pain.

Due to the interrelated causes of facet joint and intervertebral disc pain, a precise diagnosis of sacroiliac joint pain is difficult. Imaging methods, controlled local anesthetic blocks, history taking, and physical examinations can all be used to make a diagnosis.

When people are unable to have surgery because of challenges with their health or other issues, steroids can be used to alleviate severe pain that has to be treated surgically. However, using steroids can have a number of negative consequences, including exhaustion, nausea, face flushing, and fever. One common steroid side effect is the Elevation of blood glucose levels which can be challenging to diabetic patients.

The hypothalamic-pituitary-adrenal (HPA) axis can be inhibited by the administration of steroids, which puts patients at risk for adrenal insufficiency and makes blood glucose management difficult , as it also raises the random blood sugar levels. Additionally, it can increase insulin resistance and blood glucose levels by suppressing the activity of glucose metabolism and promoting gluconeogenesis.

As a result, investigating a way to reduce the difficulty and minimize complications for people with diabetes is needed..

In comparison to those without diabetes mellitus (DM), patients with DM are more susceptible to vascular damage, joint and disk abnormalities, and degenerative changes. They also have a greater frequency of illnesses affecting the shoulders and spine. Because steroid usage increases the risk of high blood glucose in individuals with diabetes mellitus, the active use of steroids in clinical practice is restricted.

Blood glucose rise following steroid injection in particular regions, such as the wrist, finger, shoulder, and knee, has been the subject of many investigations recently.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Fayoum, Egypt
        • Fayoum university hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (age ≥ 18 years).
  • Diagnosed with diabetes mellitus.
  • Scheduled for ultrasound-guided sacroiliac joint injections for pain management.

Exclusion Criteria:

  • Patients with contraindications to chromium supplementation like people with kidney or liver disorders or people with iron deficiency.
  • Patients with a history of chromium allergy.
  • Pregnant or lactating women.
  • Patients with uncontrolled diabetes (HbA1c > 9%).
  • Cardiac, renal, hepatic, coagulopathy.
  • Lumbar Spine deformity.
  • Obesity BMI ( 35 kg/m²)
  • Local infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chromium group
Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection.
Drug: Chromium
Participants in the experimental group will receive oral chromium supplementation, the dosage of which is determined based on previous studies(200 mcg daily) taking into account safety and efficacy considerations. The supplementation will commence for 45 days following the injection.
Other Names:
  • Chromium picolinate
No Intervention: Non chromium group
Participants will not receive chromium after sacroiliac joint injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Random blood sugar
Time Frame: Every day for one week, then at 2 Weeks, 3 Weeks, 6 Weeks
Blood glucose levels will be measured using a glucometer or laboratory analysis.
Every day for one week, then at 2 Weeks, 3 Weeks, 6 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oral hypoglycemic drug dose
Time Frame: Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks
It will be assessed through participant self-reporting and clinical evaluation.
Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks
Total analgesic consumption
Time Frame: Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.
It will be assessed through participant self-reporting and clinical evaluation.
Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.
Vas Score
Time Frame: Post-intervention at 1 Month, 3 Months, 6 Months
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Post-intervention at 1 Month, 3 Months, 6 Months
Side effects of chromium supplementation
Time Frame: Post-intervention for 3 months
According to isolated case reports, chromium supplements might cause gastrointestinal symptoms, weight loss, anemia, allergy.
Post-intervention for 3 months
HbA1c
Time Frame: Pre-intervention and at 6 weeks after intervention
Glycated hemoglobin test is a blood test that shows what your average blood sugar level was over the past two to three months.
Pre-intervention and at 6 weeks after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fayoum University

Investigators

  • Principal Investigator: Mohamed A Hamed, MD, faculty of medicine, fayoum university
  • Principal Investigator: Atef M Sayed, MD, faculty of medicine, fayoum university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M725

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Clinical Trials on Chromium

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe