Health Condition 1: N951- Menopausal and female climactericstates Health Condition 2: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Nil: Nil
Sponsors
Dr Susan Aishwarya S
Eligibility
Inclusion criteria
Inclusion criteria: With at least 12 months of amenorrhea, indicating the onset of menopause. Women diagnosed with type 2 diabetes mellitus, selected based on the American Diabetes Association criteria of HbA1c more than or equal to 6.5% or fasting plasma glucose more than or equal to 126mg/dL. Additionally, women without diabetes with normal fasting glucose levels less than 100 mg/dL will be included. All participants had to provide informed consent and express willingness to take part in this study.
Exclusion criteria
Exclusion criteria: Women with type 1 diabetes mellitus, history of malignancies, thyroid disorders, chronic kidney disease, or primary/secondary hyperparathyroidism are excluded. Women on medications that could influence bone metabolism, such as corticosteroids, bisphosphonates, hormone replacement therapy, or thiazolidinedione, as well as those with metabolic bone diseases or autoimmune disorders affecting bone health are excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in bone mineral density at lumbar spine and femoral neck (measured by DXA) and serum levels of bone turnover markers (osteocalcin, CTX-I, P1NP) and bone-regulatory gene expression (DKK1, RUNX2, IGF1, SIRT1, AGER) between postmenopausal women with and without Type 2 Diabetes Mellitus.Timepoint: 3 months to 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between serum estrogen, PTH, and Vitamin D levels with bone turnover markers (osteocalcin, CTX-I, P1NP) in postmenopausal women with and without T2DMTimepoint: 1 week to 3 weeks;Correlation of glycemic indices (HbA1c, fasting glucose, postprandial glucose, fasting insulin) with BMD and biochemical bone health parametersTimepoint: 1 week to 3 weeks;Association between bone-regulatory gene expression levels (DKK1, IGF1, SIRT1, AGER) and biochemical bone parameters in diabetic versus non-diabetic postmenopausal womenTimepoint: 4 weeks to 6 weeks | — |
Countries
India
Contacts
Public ContactDr Susan Aishwarya S
SRM Medical College Hospital and Research Centre
Outcome results
None listed