| CTRI Number |
CTRI/2019/06/019562 [Registered on: 06/06/2019] Trial Registered Prospectively |
| Last Modified On: |
05/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
STUDY OF ASSESSING RISK OF DIABETES MELLITUS IN DEVELOPING OSTEOPOROSIS |
|
Scientific Title of Study
|
STUDY OF BONE MINERAL DENSITY OF PATIENTS WITH TYPE 2 DIABETES MELLITUS IN COMPARISON TO THE NORMAL POPULATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANUPA JOHN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE, KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
8281497212 |
| Fax |
|
| Email |
anupajohn7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHIVASHANKAR |
| Designation |
PROFESSOR AND HOU |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE, KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
DR SHIVASHANKAR |
| Designation |
PROFESSOR AND HOU |
| Affiliation |
KASTURBA MEDICAL COLLEGE |
| Address |
DEPARTMENT OF GENERAL MEDICINE, KASTURBA MEDICAL COLLEGE, MANIPAL
Udupi
KARNATAKA
576104
India |
| Phone |
9448623861 |
| Fax |
|
| Email |
shi.sha@manipal.edu |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF GENERAL MEDICINE KASTURBA MEDICAL COLLEGE |
|
|
Primary Sponsor
|
| Name |
ANUPA JOHN |
| Address |
DEPARTMENT OF GENERAL MEDICINE,KASTURBA MEDICAL COLLEGE, MANIPAL |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR ANUPA JOHN |
KASTURBA MEDICAL COLLEGE |
DEPARTMENT OF GENERAL MEDICINE, KASTURBA MEDICAL COLLEGE
MANIPAL
Udupi
KARNATAKA |
8281497212
anupajohn7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Controls
|
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
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Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
GROUP A-PATIENTS WITH TYPE II DIABETES MELITUS
GROUP B-PATIENTS WITH OUT TYPE II DIABETES MELITUS |
|
| ExclusionCriteria |
| Details |
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. |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS AND COMPARE THE BONE MINERAL DENSITY OF PATIENTS WITH TYPE 2 DIABETES MELLITUS VS NON DIABETIC PATIENTS |
12.1.2019 to 31.07.2019 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 |
|
|
Target Sample Size
|
Total Sample Size="344"
Sample Size from India="344"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
16/06/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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.
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