An observational study in Type 2 Diabetes Mellitus, Hypoglycemia and Frailty, sponsored by Samara State Medical University. Completed at 1 site in Russia. Open to female participants aged 60 Years to 86 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Samara State Medical University · Observational
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.
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:
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 200 is below the median of 300 across 1,622 observational studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Samara State Medical University is the lead sponsor of 17 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female patients aged 60-86 years with type 2 diabetes mellitus undergoing inpatient treatment at endocrinology departments of Samara City Hospital No. 6. Consecutive sampling was used among patients meeting inclusion criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Female patients aged 60-74 years with type 2 diabetes mellitus (n=153), divided into subgroups with hypoglycemia (n=59, 38.6%) and without hypoglycemia (n=94, 61.4%). Comprehensive geriatric assessment and laboratory evaluation performed.
Diagnostic Test: Comprehensive Geriatric Assessment · Diagnostic Test: Sarcopenia assessment · Diagnostic Test: Laboratory assessment
Female patients aged 75-86 years with type 2 diabetes mellitus (n=47), divided into subgroups with hypoglycemia (n=34, 72.3%) and without hypoglycemia (n=13, 27.7%). Comprehensive geriatric assessment and laboratory evaluation performed.
Diagnostic Test: Comprehensive Geriatric Assessment · Diagnostic Test: Sarcopenia assessment · Diagnostic Test: Laboratory 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.
Also known as: CGA
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.
Also known as: EWGSOP2 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.
Also known as: Biochemical analysis
Hypoglycemia frequency
Frequency of hypoglycemic episodes documented in medical history and medical records.
Time frame: From enrollment to the end of treatment at 12 weeks
Sarcopenia prevalence
Assessment of sarcopenia prevalence according to EWGSOP2 criteria.
Time frame: From enrollment to the end of treatment at 12 weeks
Predictive model development
Development of extended and shortened mathematical models for hypoglycemia risk .
Time frame: From enrollment to the end of treatment at 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2020 to primary completion in Dec 2025, 71 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Samara State Medical University