Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus
HYPOGLYCEMIA16
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFirst Submitted
Initial submission to the registry
July 30, 2026
CompletedFirst Posted
Study publicly available on registry
October 21, 2026
CompletedOctober 21, 2026
September 1, 2026
6 years
July 30, 2026
October 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hypoglycemia frequency
Frequency of hypoglycemic episodes documented in medical history and medical records.
From enrollment to the end of treatment at 12 weeks
Secondary Outcomes (1)
Sarcopenia prevalence
From enrollment to the end of treatment at 12 weeks
Other Outcomes (1)
Predictive model development
From enrollment to the end of treatment at 12 weeks
Study Arms (2)
Elderly patients (60-74 years)
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.
Senile patients (75-86 years)
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.
Interventions
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.
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.
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.
Eligibility Criteria
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.
You may qualify if:
- Female sex
- Presence of type 2 diabetes mellitus
- Signed informed consent
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samara City Hospital No. 6, Endocrinology Department
Samara, Samara Oblast, 443099, Russia
Biospecimen
Blood and serum samples were collected for laboratory analysis including complete blood count, biochemical analysis, and HbA1c measurement.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Svetlana V. Bulgakova, MD, PhD, Professor
Samara State Medical University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2026
First Posted
October 21, 2026
Study Start
January 1, 2020
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
October 21, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share