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COMPLETED
NCT07887334

Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus

Sponsor: Samara State Medical University

View on ClinicalTrials.gov

Summary

Hypoglycemia poses a particular danger for elderly patients with type 2 diabetes mellitus (T2DM). According to data, more than 30% of patients aged 60-69 years experience hypoglycemic episodes, and among persons over 85 years this figure exceeds 50%. The high risk is due to age-related changes: slowing of drug metabolism, decreased renal and hepatic function, weakening of counter-regulatory hormonal reactions, and impaired recognition of warning symptoms of severe hypoglycemia. The consequences of hypoglycemia in old age are especially severe, including increased risk of cardiovascular catastrophes, falls and fractures, and cognitive decline. This study aimed to identify predictors of hypoglycemia and assess its probability in elderly and senile women with T2DM for prevention in clinical practice.

Official title: Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus: A Cross-Sectional Study

Key Details

Gender

FEMALE

Age Range

60 Years - 86 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2020-01-01

Completion Date

2025-12-31

Last Updated

2026-10-21

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Comprehensive Geriatric Assessment

Comprehensive geriatric assessment including "Age Is Not a Hindrance" screening questionnaire, Barthel Index for basic activities of daily living, Lawton Scale for instrumental activities of daily living, Mini-Mental State Examination (MMSE) for cognitive function, Geriatric Depression Scale (GDS-15) for depression screening, Mini Nutritional Assessment (MNA) for nutritional status, and Charlson Comorbidity Index.

DIAGNOSTIC_TEST

Sarcopenia assessment

Sarcopenia assessment according to EWGSOP2 criteria: bioimpedance analysis for muscle mass (ASMMI), handgrip dynamometry for upper limb strength, 5-times sit-to-stand test for lower limb strength, gait speed measurement for physical performance.

DIAGNOSTIC_TEST

Laboratory assessment

Laboratory assessment including complete blood count, biochemical analysis (creatinine, eGFR by CKD-EPI, total cholesterol, LDL, HDL, triglycerides, total protein, ALT, AST, total bilirubin), and HbA1c measurement.

Locations (1)

Samara City Hospital No. 6, Endocrinology Department

Samara, Samara Oblast, Russia