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

NCT06351176 | Enrolling By Invitation

• 1 other identifier: 2024-6819
• Study Type: observational
• Target: 163
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2

  aBMD measured by DXA scan

  Between the baseline and the 4-year visit

Secondary Outcomes (7)

• Change in areal bone mineral density (aBMD) at the spine in g/cm2

  Between the baseline and the 4-year visit

• Change in areal bone mineral density (aBMD) at the total hip in g/cm2

  Between the baseline and the 4-year visit

• Change in areal bone mineral density (aBMD) at the distal third of radius in g/cm2

  Between the baseline and the 4-year visit

• Change in Trabecular bone score (TBS) (unitless)

  Between the baseline and the 4-year visit

• Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years

  4-year visit

Other Outcomes (44)

• Areal bone mineral density at the femoral neck, g/cm2

  4-year visit

• Areal bone mineral density at the femoral neck, T-Score

  4-year visit

• Areal bone mineral density at the femoral neck, Z-Score

  4-year visit

Study Arms (2)

Individuals with type 1 diabetes

Diagnostic Test: Clinical tests; Diagnostic Test: Biochemical tests; Diagnostic Test: DXA scan with TBS and VFA; Diagnostic Test: AGEReader

Healthy controls

Diagnostic Test: Clinical tests; Diagnostic Test: Biochemical tests; Diagnostic Test: DXA scan with TBS and VFA; Diagnostic Test: AGEReader

Interventions

Clinical tests DIAGNOSTIC_TEST

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

Healthy controls; Individuals with type 1 diabetes

Biochemical tests DIAGNOSTIC_TEST

The investigators perform blood and urine tests in every participant.

Healthy controls; Individuals with type 1 diabetes

DXA scan with TBS and VFA 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.

Healthy controls; Individuals with type 1 diabetes

AGEReader DIAGNOSTIC_TEST

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

Healthy controls; Individuals with type 1 diabetes

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

127 individuals with type 1 diabetes and 65 healthy subjects from the DenSiFy (Diabetes Spine Fractures) study (NCT04064437)

You may qualify if:

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

You may not qualify if:

• 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)
• Age 20 years and older.
• As above (as individuals with diabetes), and :
• Diagnosis of diabetes or prediabetes;
• Celiac disease;
• Chronic kidney disease (CrCl \< 60 mL/min).

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• Diabetes Canada: collaborator

Study Sites (2)

Institut de recherches cliniques de Montréal (IRCM)

Montreal, Quebec, H2W 1R7, Canada

Location

Centre de recherche du CHU de Québec-Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (serum and plasma)

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Bone Diseases, Metabolic

Interventions

Absorptiometry, Photon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Densitometry; Photometry; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Claudia Gagnon, MD

  CHU de Québec- Université Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: July 4, 2023
• Primary Completion: December 22, 2024
• Study Completion: August 29, 2025
• Last Updated: April 8, 2024

Record last verified: 2024-04

Locations

CA (2)