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临床试验/CTRI/2019/06/019562
CTRI/2019/06/019562尚未招募1 期

STUDY OF BONE MINERAL DENSITY OF PATIENTS WITH TYPE 2 DIABETES MELLITUS IN COMPARISON TO THE NORMAL POPULATION

ANUPA JOHN1 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2019年6月16日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
344
试验地点
1
主要终点
TO ASSESS AND COMPARE THE BONE MINERAL DENSITY OF PATIENTS WITH TYPE 2 DIABETES MELLITUS VS NON DIABETIC PATIENTS

研究概览

简要总结

Diabetes has evolved as one of the world’s biggest health problems and the disease affects almost all organ systems with substantial morbidity and mortality. Osteoporosis is a silent disease with a

harmful impact on bone health.

Most studies indicate less bone mineral density (BMD) with insulin dependent diabetes mellitus but with type 2 diabetes, some authors report increased, some report decreased and some others

report unaltered BMD. Early identification of reduction in bone mass in a diabetic patient may be helpful in preventing the bone loss and future fracture risk.

Diabetes could influence bone through several mechanisms. Hyperinsulinemia may promote bone formation. However, low levels of insulin and the progression of T2DM may cause reductions in BMD.

Higher glucose levels in the blood interact with several proteins to generate a higher concentration of advanced glycation end-products (AGEs). Yamagishi et al. hypothesized that

AGEs in collagen may interact with bone to reduce bone strength, resulting in osteoporosis in patients with diabetes. Accumulated AGEs in the body may stimulate apoptosis of osteoblasts,

thereby contributing to the defective bone formation.

Diabetic osteopathy may need attention as one of the common disease complications. Recently,BMD has been identified as a key determinant of future fracture risks. Each standard deviation of

a decrease in BMD yields three-fold increases in fracture risk. Quantitative ultrasound (QUS) is a noninvasive, patient-friendly method used for estimation of the bone mass. It would also

provide information regarding the bone elasticity and architecture.

The aim of this study is to assess and compare the Bone mineral density of patients with Type 2 Diabetes Mellitus in comparison with the normal population. A total of 344 patients (172 Diabetic and 172 non Diabetic) will be enrolled into this study.

Non Diabetic controls/Diabetic patients will be assessed for Osteopenia/Osteoporosis on OPD Basis taking into consideration the inclusion and exclusion criteria. Patients with type 2 Diabetes Mellitus will be screened for Microvascular complications before assessing Bone Mineral Density after taking into consideration the inclusion and exclusion criteria. Patients will be required to answer a questionnaire that entails the details of their Medical history. Routine Screening of all Diabetic patients for Microvascular complications will be done.

Patients who have been previously screened for microvascular complications will also be considered. No additional Blood tests will be required. Routine blood tests done will be used. Bone Mineral Density will be assessed by Quantitative Ultrasound. Calcaneum will be the site which will be used to assess the Bone mineral Density. Procedure will take less than a minute and will be non invasive. Results of which will be informed to the patient.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • GROUP A-PATIENTS WITH TYPE II DIABETES MELITUS GROUP B-PATIENTS WITH OUT TYPE II DIABETES MELITUS.

排除标准

  • PATIENTS WITH CKD(GFR 60 ML/MIN) MALABSORPTION SYNDROMES CHRONIC PANCREATITIS PARATHYROID GLAND DISORDERS INFLAMMATORY DISEASES SUCH AS RHEUMATOID ARTHRITIS, SLE ON TREATMENT WITH DIURETICS, ANTICONVULSANTS, THIAZOLIDINEDIONES, FIBRATES, IMMUNOSUPPRESSANTS, STEROIDS.

结局指标

主要结局

TO ASSESS AND COMPARE THE BONE MINERAL DENSITY OF PATIENTS WITH TYPE 2 DIABETES MELLITUS VS NON DIABETIC PATIENTS

时间窗: 12.1.2019 to 31.07.2019

次要结局

  • TO ASSESS AND COMPARE THE BONE MINERAL DENSITY OF PATIENTS WITH TYPE 2 DIABETES MELLITUS WITH MICROVASCULAR COMPLICATIONS VS DIABETIC PATIENTS WITHOUT MICROVASCULAR COMPLICATIONS(12.1.2019 to 31.07.2019)

研究者

发起方
ANUPA JOHN
申办方类型
Private medical college

研究点 (1)

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