Effect of GLP-1 Receptor Agonists on Trabecular Bone Score and Visceral Adiposity in Postmenopausal Women With Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Trabecular Bone Score
研究概览
简要总结
This study will help determine the effect of Glucagon Like Peptide-1 (GLP-1)receptor agonists on bone strength in postmenopausal women with type 2 diabetes mellitus (T2DM)
详细描述
Postmenopausal women with diabetes mellitus have a higher risk of osteoporotic fractures, with significant associated mortality and morbidity. Osteoporosis is underdiagnosed in diabetes, as the bone mineral density (BMD) as currently measured is often normal despite underlying abnormalities. The trabecular bone score (TBS) is a novel modality to assess bone microarchitecture and accurately assess fracture risk in patients with diabetes. Due to increased co-prevalence of osteoporosis and diabetes mellitus, the potential effects of antidiabetic medications on fracture risk assume importance.
Based on findings in animal studies, we hypothesize that GLP-1 receptor agonists increase TBS in postmenopausal women with (T2DM). The investigators propose a prospective non-randomized study by enrolling 48 patients (24 in the GLP-1 group and 24 in the non-GLP group). Dual-energy X-ray Absorptiometry (DXA )scans, markers of bone formation, and resorption, and selected inflammatory markers will be assessed at baseline, six months, and one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Type 2 Diabetes Mellitus
- •Postmenopausal female
- •Age >55 years
- •Hemoglobin A1c between 7-10% within 6 months of the first visit.
排除标准
- •Patients with type 1 Diabetes mellitus
- •Patients with a history of GLP-1 receptor agonist/DPP4 inhibitor use
- •eGFR <30 ml/min in the last 3 months
- •Patients with a history of pancreatitis
- •Personal or family history of medullary thyroid cancer
- •Patients with a history of treatment with anti-osteoporosis agents
- •Documented secondary osteoporosis
- •Documented presence of prosthesis or devices in the spine
- •Unwilling or unable to consent
研究组 & 干预措施
GLP-1 cohort
Participants on GLP-1 receptor agonists
干预措施: GLP-1 receptor agonist (Drug)
结局指标
主要结局
Trabecular Bone Score
时间窗: 12 months after index date
The change in TBS from baseline to six months and one year after the initiation of a GLP-1 receptor agonist. TBS will be assessed by DXA scans done at baseline, six months and one year.
次要结局
- Sclerostin and Bone Formation Markers(12 months after index date)
- Visceral Fat Mass(12 months after index date)
- Inflammatory Markers and Bone Resorption Markers(12 months after index date)