Effect of Chromium on Blood Sugar After Sacroiliac Joint Injection

NCT06709313 | Active Not Recruiting Phase 4

• 1 other identifier: M725
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Sacro Iliac Joint Pain; Diabetes

Keywords

Chromium; Sacroiliac joint injection

Outcome Measures

Primary Outcomes (1)

• Random blood sugar

  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 Outcomes (5)

• Oral hypoglycemic drug dose

  Pre-intervention then post intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks

• Total analgesic consumption

  Post- intervention at 1 week , 2 weeks , 3 weeks , 4 weeks , 6 weeks.

• Vas Score

  Post-intervention at 1 Month, 3 Months, 6 Months

• Side effects of chromium supplementation

  Post-intervention for 3 months

• HbA1c

  Pre-intervention and at 6 weeks after intervention

Study Arms (2)

chromium group

EXPERIMENTAL

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

Non chromium group

NO INTERVENTION

Participants will not receive chromium after sacroiliac joint injection.

Interventions

Chromium DRUG

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.

Also known as: Chromium picolinate

chromium group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

FAYOUM University hospital

Al Fayyum, Egypt

Location

Related Publications (17)

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  PMID: 21540770 BACKGROUND

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• Iwamoto T, Kagawa Y, Naito Y, Kuzuhara S, Kojima M. Steroid-induced diabetes mellitus and related risk factors in patients with neurologic diseases. Pharmacotherapy. 2004 Apr;24(4):508-14. doi: 10.1592/phco.24.5.508.33355.

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MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Chromium; picolinic acid

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Mohamed A Hamed, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

• Atef M Sayed, MD

  Faculty of medicine, Fayoum university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Model Details: 2 groups: Experimental 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. Control Group: Participants will not receive chromium after sacroiliac joint injection.

Study Record Dates

• First Submitted: November 25, 2024
• First Posted: November 29, 2024
• Study Start: June 3, 2024
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)