Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes : DenSiFy (Diabetes Spine Fractures) Cohort
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of type 1 diabetes for at least 5 years;
- •Age 20 years and older.
排除标准
- •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).
结局指标
主要结局
Change in areal bone mineral density (aBMD) at the femoral neck in g/cm2
时间窗: Between the baseline and the 4-year visit
aBMD measured by DXA scan
次要结局
- Change in areal bone mineral density (aBMD) at the total hip in g/cm2(Between the baseline and the 4-year visit)
- Glycemic control, assessed with mean glycated hemoglobin (HbA1c) of the past 7 years(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)
- Change in areal bone mineral density (aBMD) at the spine in g/cm2(Between the baseline and the 4-year visit)
- Glycemic control, assessed with skin advanced glycation end products (AGEs)(4-year visit)
- Presence of a microvascular complication (neuropathy, nephropathy, retinopathy)(4-year visit)
研究者
Claudia Gagnon
MD
CHU de Quebec-Universite Laval