Type 2 Diabetes Mellitus, Hypoglycemia, Frailty, Sarcopenia
Conditions
Keywords
Hypoglycemia, Type 2 diabetes mellitus, Elderly, Comprehensive geriatric assessment, Frailty, Sarcopenia, Risk assessment, Predictive modeling
Brief 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.
Detailed description
This cross-sectional study included 200 female patients with T2DM divided into two age categories: 153 elderly patients (60-74 years) and 47 senile patients (75-86 years). For subsequent statistical analysis, subgroups were identified in each category depending on the presence of a history of hypoglycemia. All patients underwent inpatient treatment in endocrinology departments of Samara City Hospital No. 6. Objectives: 1. To determine the frequency of hypoglycemic episodes in elderly and senile female patients considering antidiabetic medications, T2DM duration, glycemic variability, and HbA1c level. 2. To assess the structure of multimorbidity, prevalence of frailty and prefrailty syndromes using the "Age Is Not a Hindrance" questionnaire in elderly and senile female patients with T2DM with and without hypoglycemia. 3. To conduct a comprehensive geriatric assessment (CGA) with determination of basic (Barthel Index) and instrumental (Lawton Scale) activities, cognitive functions (MMSE), depressive disorders (GDS-15), nutritional status (MNA) in elderly and senile female patients with T2DM with and without hypoglycemia. 4. To assess sarcopenia prevalence via determination of muscle mass (bioimpedance analysis), muscle function (gait speed), upper (handgrip dynamometry) and lower (5-times sit-to-stand test) limb strength in elderly and senile female patients with T2DM with and without hypoglycemia. 5. To identify significant clinical, laboratory and instrumental predictors of hypoglycemia in elderly and senile female patients with T2DM. 6. To develop and implement in clinical practice hypoglycemia risk assessment models for elderly and senile female patients with T2DM.
Interventions
DIAGNOSTIC_TESTComprehensive 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_TESTSarcopenia 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_TESTLaboratory 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.
Sponsors
Samara State Medical University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
60 Years to 86 Years
Healthy volunteers
No
Inclusion criteria
* Female sex * Presence of type 2 diabetes mellitus * Signed informed consent
Exclusion criteria
* Type 1 diabetes mellitus * Acute decompensation of carbohydrate metabolism at the time of the study * Acute infectious diseases and exacerbation of concomitant chronic pathologies * Oncological diseases at the time of the study * Systemic joint and connective tissue diseases * Osteoarthritis of large joints with impaired joint function II-IV degree * Severe cognitive impairments preventing survey and examination * Presence of a pacemaker * Bilateral endoprosthetics of large joints or metal structures in the spine * Glucocorticoid intake at the time of the study and within 1 month prior * Terminal stage of chronic kidney disease (eGFR less than 15 ml/min/1.73m² by CKD-EPI) * Impaired liver function (transaminase activity exceeding 5 times the upper limit of normal)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia frequency | From enrollment to the end of treatment at 12 weeks | Frequency of hypoglycemic episodes documented in medical history and medical records. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sarcopenia prevalence | From enrollment to the end of treatment at 12 weeks | Assessment of sarcopenia prevalence according to EWGSOP2 criteria. |
Countries
Russia
Contacts
PRINCIPAL_INVESTIGATORSvetlana V. Bulgakova, MD, PhD, Professor
Samara State Medical University
Outcome results
None listed