Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes

NCT ID: NCT06351176

Last Updated: 2024-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

163 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-04

Study Completion Date

2025-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Background : Type 1 diabetes (T1D) is associated with an increased risk of fractures. The mechanisms accounting for this bone fragility are not yet fully understood. As T1D is often diagnosed in childhood or early adulthood, the lower bone mineral density (BMD) and deteriorated bone microarchitecture observed in T1D may reflect changes in the bone that occurred before or at the time of peak bone mass achievement. There is a lack of high-quality prospective studies to determine whether adults with T1D continue to lose BMD or deteriorate bone quality compared with controls. Moreover, while chronic hyperglycemia is a risk factor for fracture in T1D, it is unknown if better glycemic control affects bone outcomes.

This prospective multicenter cohort study aims: (1) To compare the changes in the following outcomes over 4 years in adults with T1D and controls without diabetes of similar age, sex and body-mass index distribution: BMD by dual-energy X-ray absorptiometry (DXA) at the femoral neck, hip, spine, and radius, trabecular bone score (TBS) by DXA, and serum biochemical markers of bone turnover (BTMs); (2) To evaluate whether long-term glycemic control or the presence of a microvascular complication are independent predictors of the changes in BMD and TBS in people with T1D.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1 Bone Health Bone Loss Bone Diseases, Metabolic Hyperglycaemia Due to Type 1 Diabetes Mellitus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Individuals with type 1 diabetes

Clinical tests

Intervention Type DIAGNOSTIC_TEST

The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.

Biochemical tests

Intervention Type DIAGNOSTIC_TEST

The investigators perform blood and urine tests in every participant.

DXA scan with TBS and VFA

Intervention Type DIAGNOSTIC_TEST

The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) including trabecular bone score (TBS) and Vertebral Fracture Assessment (VFA) in every participant.

AGEReader

Intervention Type DIAGNOSTIC_TEST

The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.

Healthy controls

Clinical tests

Intervention Type DIAGNOSTIC_TEST

The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.

Biochemical tests

Intervention Type DIAGNOSTIC_TEST

The investigators perform blood and urine tests in every participant.

DXA scan with TBS and VFA

Intervention Type DIAGNOSTIC_TEST

The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) including trabecular bone score (TBS) and Vertebral Fracture Assessment (VFA) in every participant.

AGEReader

Intervention Type DIAGNOSTIC_TEST

The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinical tests

The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.

Intervention Type DIAGNOSTIC_TEST

Biochemical tests

The investigators perform blood and urine tests in every participant.

Intervention Type DIAGNOSTIC_TEST

DXA scan with TBS and VFA

The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) including trabecular bone score (TBS) and Vertebral Fracture Assessment (VFA) in every participant.

Intervention Type DIAGNOSTIC_TEST

AGEReader

The investigators perform a skin advanced glycation end products (AGEs) measurement with the AGE Reader machine in every participant.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of type 1 diabetes for at least 5 years;
* Age 20 years and older.


* Age 20 years and older.

Exclusion Criteria

* Pregnancy, delivery or breastfeeding in the past 6 months;
* Conditions associated with bone disease (significant liver disease, intestinal malabsorption other than celiac disease, organ transplant, active cancer, rheumatoid arthritis, hyperthyroidism, hypothyroidism with abnormal TSH, hyperparathyroidism, hypoparathyroidism, hypogonadism, acromegaly, Cushing syndrome, adrenal insufficiency);
* Any of these medications since the first DenSiFy study visit : biphosphonates, teriparatide, denosumab, calcitonin, glucocorticoids ≥ 7,5 mg prednisone/day or equivalency ≥ 3 months, aromatase inhibitors, antiandrogens, antiepileptic drugs, anticoagulants, thiazolidinediones;
* Inability to consent.

Healthy controls who have participated in the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)


* As above (as individuals with diabetes), and :
* Diagnosis of diabetes or prediabetes;
* Celiac disease;
* Chronic kidney disease (CrCl \< 60 mL/min).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Diabetes Canada

OTHER

Sponsor Role collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Claudia Gagnon

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Claudia Gagnon, MD

Role: PRINCIPAL_INVESTIGATOR

CHU de Québec- Université Laval

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut de recherches cliniques de Montréal (IRCM)

Montreal, Quebec, Canada

Site Status

Centre de recherche du CHU de Québec-Université Laval

Québec, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-6819

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.