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Hypoglycemia | Hypoglycemia (Low Blood Sugar) and the Heart

Hypoglycemia research study

What is the primary objective of this study?

The risk of hypoglycemia (low blood sugar) associated with the treatment of diabetes increases with age. Hypoglycemia is a common reason for admission to hospital for older patients with diabetes. Older patients are often unaware that their blood sugar is low and asymptomatic hypoglycemia, as assessed by continuous blood sugar monitoring, is frequent in the elderly. There is also evidence that older people with diabetes are more likely to develop cardiovascular events such a heart attack and more likely to die suddenly when compared to older people without diabetes. It is possible that low blood sugar levels contribute to the increased frequency of these events, but this possibility has never been studied. The purpose of this study is to assess how frequently low blood sugar occurs in older patients with diabetes and to see if low blood sugars adversely affect heart function in these patients.

Who is eligible to participate?

Inclusion Criteria: - 70 years old and over - had type 2 diabetes for at least 5 years - treated with insulin glargine. - BMI of between 20 and 35 Kg/M2, - A1c between 7 and 8.5 %. - well controlled hypertension and hyperlipidemia. Exclusion Criteria: - cannot speak english or give informed consent, or cognitive impairment - glomerular filtration rate (GFR) less than 40ml/min, - poorly controlled Chronic Heart Failure - active coronary artery disease - active cerebrovascular disease although a past history of CAD or stroke will not results in exclusion.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hypoglycemia

Type 2 Diabetes

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Recruiting

Start Date: March 2015

Completed Date: December 2018

Phase:

Type: Observational

Design:

Primary Outcome: blood sugar measurement

Secondary Outcome: Monitor cardiac function

Study sponsors, principal investigator, and references

Principal Investigator: Graydon S Meneilly, MD

Lead Sponsor: University of British Columbia

Collaborator: icentia

More information:https://clinicaltrials.gov/show/NCT01980914

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