NCT07017985

Brief Summary

The purpose of the study is to assess, through systematic screening, the prevalence of diabetes or prediabetes in patients who are candidates for lumbar spine surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Mar 2024Jun 2026

Study Start

First participant enrolled

March 28, 2024

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 12, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

2.3 years

First QC Date

June 4, 2025

Last Update Submit

June 11, 2025

Conditions

Spine Disease

Keywords

Spine surgeryDiabetes

Outcome Measures

Primary Outcomes (1)

  • Diabetes or prediabetes présence

    Diabetes is defined as a blood glucose level of at least 1.26 g/L and a glycated hemoglobin level greater than or equal to 6.5%. Prediabetes is defined as a blood glucose level greater than 1.10 g/L and less than 1.26 g/L and a glycated hemoglobin level between 5.7% and 6.4%.

    Day 1

Secondary Outcomes (6)

  • Low back pain

    Day 0

  • Low back pain

    Month 3

  • Radicular pain

    Day 0

  • Radicular pain

    Month 3

  • Functional Impact of the Disease

    Day 0

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of patients who are candidates for lumbar spine surgery

You may qualify if:

  • Adult patients,
  • Patients who have been informed of the research and have not indicated their opposition to the use of their medical data,
  • Patients who are candidates for their first lumbar spine surgery, whether instrumented or not

You may not qualify if:

  • Non-instrumented percutaneous surgery (cementoplasty)
  • Presence of spinal osteosynthesis equipment
  • Surgery performed for an infectious or tumoral spinal condition
  • Surgery via an anterior or lateral approach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Privé Jacques Cartier

Massy, 91300, France

RECRUITING

MeSH Terms

Conditions

Spinal DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Raphaël PIETTON, MD

CONTACT

01 60 13 60 60drraphaelpietton@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2025

First Posted

June 12, 2025

Study Start

March 28, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

June 12, 2025

Record last verified: 2025-06

Locations

FR(1)