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Hypoglycemia risk assessment in elderly and senile female patients with type 2 diabetes mellitus: a Cross-Sectional study

NCT ID NCT07887334

Sponsor: Samara State Medical University Source: ClinicalTrials.gov ↗

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Not yet recruiting
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Running, but no longer taking on new participants.
Completed This study
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Stopped early
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Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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The treatment has been approved, so it is available normally rather than through this programme.

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First seen Oct 21, 2026 · Last updated Oct 22, 2026 · Updated 1 time

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.

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Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

Jan 2020

Finished

Dec 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

60 to 86 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Frailty hypoglycemia Sarcopenia type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Frailty Hypoglycemia Sarcopenia Type 2 diabetes mellitus

Contacts and locations

Locations

  • Samara City Hospital No. 6, Endocrinology Department

    Samara, Samara Oblast, 443099, Russia

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