Type 2 Diabetes MellitusHYPOGLYCEMIA16NCT07887334
Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus
An observational study of Type 2 Diabetes Mellitus and Hypoglycemia, run by Samara State Medical University at 1 site in Russia.
Trial 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%. Read more about this study
- Who is it for?
- Ages 60 to 86 years, women only
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypoglycemia, Frailty
- What is being tested?
- Comprehensive Geriatric Assessment, Sarcopenia assessment and Laboratory assessment
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 86 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Female sex
- Presence of type 2 diabetes mellitus
- Signed informed consent
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Russia1 site
Samara City Hospital No. 6, Endocrinology Department
Samara, Samara Oblast, 443099
About this study
Official title: Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus: A Cross-Sectional Study
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.
Read the 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:
- To determine the frequency of hypoglycemic episodes in elderly and senile female patients considering antidiabetic medications, T2DM duration, glycemic variability, and HbA1c level.
- 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.
- 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.
- 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.
- To identify significant clinical, laboratory and instrumental predictors of hypoglycemia in elderly and senile female patients with T2DM.
- To develop and implement in clinical practice hypoglycemia risk assessment models for elderly and senile female patients with T2DM.
- Conditions
- Type 2 Diabetes Mellitus, Hypoglycemia, Frailty, Sarcopenia
- Being tested
- Comprehensive Geriatric Assessment, Sarcopenia assessment, Laboratory assessment
- Keywords
- Hypoglycemia, Type 2 diabetes mellitus, Elderly, Comprehensive geriatric assessment, Frailty, Sarcopenia, Risk assessment, Predictive modeling
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia, Frailty, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Geriatric AssessmentDiagnostic test
Also called CGA
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 assessmentDiagnostic test
Also called EWGSOP2 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.
Laboratory assessmentDiagnostic test
Also called Biochemical analysis
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Comprehensive Geriatric Assessment; Diagnostic Test: Sarcopenia assessment; Diagnostic Test: Laboratory assessment | |
| 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. Receives: Diagnostic Test: Comprehensive Geriatric Assessment; Diagnostic Test: Sarcopenia assessment; Diagnostic Test: Laboratory assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia frequency
Frequency of hypoglycemic episodes documented in medical history and medical records.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (1)
Sarcopenia prevalence
Assessment of sarcopenia prevalence according to EWGSOP2 criteria.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samara State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Svetlana V. Bulgakova, MD, PhD, Professor, Principal investigator, Samara State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887334
- Sponsor's protocol ID
- HYPOGLYCEMIA_RISK_2026
- Acronym
- HYPOGLYCEMIA16
- Status last verified
- Sep 2026
- First submitted
- 30 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia Risk Assessment in Elderly and Senile Female Patients With Type 2 Diabetes Mellitus: A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07887334
- Acronym / sponsor ID
- HYPOGLYCEMIA16 / HYPOGLYCEMIA_RISK_2026
- Conditions
- Type 2 Diabetes Mellitus, Hypoglycemia, Frailty, Sarcopenia
- Keywords
- Hypoglycemia, Type 2 diabetes mellitus, Elderly, Comprehensive geriatric assessment, Frailty, Sarcopenia, Risk assessment, Predictive modeling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Samara State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the frequency of hypoglycemic episodes in elderly and senile female patients considering antidiabetic medications, T2DM duration, glycemic variability, and HbA1c level.
- 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.
- 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.
- 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.
- To identify significant clinical, laboratory and instrumental predictors of hypoglycemia in elderly and senile female patients with T2DM.
- To develop and implement in clinical practice hypoglycemia risk assessment models for elderly and senile female patients with T2DM.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elderly patients (60-74 years) | – | Diagnostic Test: Comprehensive Geriatric Assessment, Diagnostic Test: Sarcopenia assessment, Diagnostic Test: Laboratory assessmentFemale 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) | – | Diagnostic Test: Comprehensive Geriatric Assessment, Diagnostic Test: Sarcopenia assessment, Diagnostic Test: Laboratory assessmentFemale 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. |
Who may qualify
- Ages
- 60 to 86 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Female sex
- Presence of type 2 diabetes mellitus
- Signed informed consent
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Geriatric AssessmentAlso: CGAComprehensive 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 | Elderly patients (60-74 years), Senile patients (75-86 years) |
| Sarcopenia assessmentAlso: EWGSOP2 assessmentSarcopenia 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 | Elderly patients (60-74 years), Senile patients (75-86 years) |
| Laboratory assessmentAlso: Biochemical analysisLaboratory 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. | Diagnostic test | Elderly patients (60-74 years), Senile patients (75-86 years) |
Primary outcome
Hypoglycemia frequency
Time frame: From enrollment to the end of treatment at 12 weeks
Frequency of hypoglycemic episodes documented in medical history and medical records.
1 secondary outcome
Sarcopenia prevalence
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Svetlana V. Bulgakova, MD, PhD, Professor principal investigator
Samara State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus and Hypoglycemia, run by Samara State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia frequency (time frame: From enrollment to the end of treatment at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.