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Osteocalcin and Atherosclerosis in Type-2 Diabetes mellitus

Association between serum osteocalcin levels and atherosclerosis in Type - 2 Diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017385
Enrollment
124
Registered
2019-02-01
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E118- Type 2 diabetes mellitus with unspecified complications

Interventions

Intervention1: B-mode Ultrasound and serum osteocalcin: A B-Mode Ultrasound shall be used to measure the Common carotid artery Intima-media thickness to assess atherosclerosis. Serum Osteocalcin will

Sponsors

Kasturba medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)All patients above 18 years of age of both sexes. 2)Type-2 Diabetes Mellitus patients according to ADA criteria Type 2 diabetes-ADA diagnosis criteria The American Diabetes Association (ADA) criteria for the diagnosis of diabetes are any of the following (5): 1)A hemoglobin A1c (HbA1c) level of 6.5% or higher; the test should be performed in a laboratory using a method that is certified by the National Glycohemoglobin Standardization Program (NGSP) and standardized or traceable to the Diabetes Control and Complications Trial (DCCT) reference assay, or 2)A fasting plasma glucose (FPG) level of 126 mg/dL (7 mmol/L) or higher; fasting is defined as no caloric intake for at least 8 hours, or 3)A 2-hour plasma glucose level of 200 mg/dL (11.1 mmol/L) or higher during a 75-g oral glucose tolerance test (OGTT), or 4)A random plasma glucose of 200 mg/dL (11.1 mmol/L) or higher in a patient with classic symptoms of hyperglycemia (ie, polyuria, polydipsia, polyphagia, weight loss) or 5)Hyperglycemic crisis .

Exclusion criteria

Exclusion criteria: Patients with- 1)Type-1 Diabetes Mellitus 2)Bone disorders like Pagetâ??s disease, Osteomalacia. 3)Thyroid disorders 4)Parathyroid disorders 5)Acromegaly, Growth hormone deficiency 6)Chronic kidney disease, liver disease. 7)Pregnancy 8)Use of oral contraceptives, hormone replacement therapy, Vitamin K, Calcium, calcitonin, bisphosphonates, Vitamin-D, Steroids.

Design outcomes

Primary

MeasureTime frame
Association between osteocalcin levels and atherosclerosis measured by Common Carotid Intima Media thickness assessed by a B-Mode Ultrasound in Type-2 diabetes mellitus.Timepoint: 09/10/2018 to 30/07/2020

Secondary

MeasureTime frame
Comparison between osteocalcin levels in patients with macrovascular complications and patients without any macrovascular complication.Timepoint: 09/10/208 to 30/07/2020

Countries

India

Contacts

Public ContactDr Sudha vidyasagar

Kasturba Medical college, Manipal

vsagar33@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026