NCT06228911

Brief Summary

a sample of 600 patients diagnosed as Knee osteoarthritis injected with 40 mg triamcinolone, recorded their morning fasting blood glucose levels for 7 days before injection used as the baseline blood glucose level, which was compared with FBS levels for 14 days after steroid injection. Our study compared the differences in blood glucose changes between HbA1c \>7% and HbA1c ≤7% groups and those between insulin and non-insulin treated groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 29, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

3.7 years

First QC Date

January 18, 2024

Last Update Submit

January 27, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • high blood glucose

    glucose increases after steroid dose

    3 years

  • low blood glucose

    glucose decreases after steroid dose

    3 years

Study Arms (2)

insulin treated group

EXPERIMENTAL
Drug: steroid (triamcinolone)

non-insulin treated groups

EXPERIMENTAL
Drug: steroid (triamcinolone)

Interventions

triamcinolone is a synthetic corticosteroid medication used topically to treat various skin conditions, to relieve the discomfort of mouth sores, and by injection into joints to treat various joint conditions

insulin treated groupnon-insulin treated groups

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 years, patients with knee osteoarthritis diagnosed according to American College of Rheumatology (ACR) Criteria (17), and grade1-3 in Kallgren-Laurence radiographic scale (18), whom failed to response to medical treatment including paracetamol and nonsteroidal anti-inflammatory medication, and to physical therapy, checking their blood glucose values daily.

You may not qualify if:

  • Patients who were unable to provide consent, patients had any contraindications to corticosteroids, patients who had received oral corticosteroid in the past 6 months or corticosteroid injection in the previous 3 months, patients who had no monitoring HbA1c level before injection or also whom had not monitor blood glucose levels before or after injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Damascus University, Syria

Damascus, 1, Syria

Location

MeSH Terms

Conditions

Osteoarthritis, KneeDiabetes Mellitus, Type 2

Interventions

SteroidsTriamcinolone

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsPregnadienesPregnanesSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor Diaa Haj Ali

Study Record Dates

First Submitted

January 18, 2024

First Posted

January 29, 2024

Study Start

January 15, 2020

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations