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

N/AEnrolling By InvitationNCT06351176

CHU de Quebec-Universite Laval163 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

163

Conditions

Diabetes Mellitus, Type 1 Bone Health Bone Loss Bone Diseases, Metabolic

Interventions

Clinical testsDIAGNOSTIC_TEST

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

Biochemical testsDIAGNOSTIC_TEST

The investigators perform blood and urine tests in every participant.

DXA scan with TBS and VFADIAGNOSTIC_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.

AGEReaderDIAGNOSTIC_TEST

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

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Individuals with type 1 diabetes who have participated in the DenSiFy (Diabetes Spine Fractures) study (NCT04064437) Inclusion Criteria: * Diagnosis of type 1 diabetes for at least 5 years; * 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) Inclusion Criteria: * Age 20 years and older. Exclusion Criteria : * As above (as individuals with diabetes), and : * Diagnosis of diabetes or prediabetes; * Celiac disease; * Chronic kidney disease (CrCl \< 60 mL/min).