Hypoglycemia (Low Blood Sugar) and the Heart
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|ClinicalTrials.gov Identifier: NCT01980914|
Recruitment Status : Recruiting
First Posted : November 11, 2013
Last Update Posted : January 18, 2018
|Condition or disease|
|Hypoglycemia Type 2 Diabetes|
Investigators propose a pilot study in 20 patients over age 70 who have type 2 diabetes and are being treated with insulin. These patients will be enrolled from the elderly diabetes clinic at Vancouver General Hospital. Patients will be asked to come to the Gerontology research laboratory in the Research Pavilion at Vancouver General Hospital. A trained research nurse will instrument each patient with an iPro2 glucose sensor (Medtronic Canada). These sensors reliably and continuously measure blood glucose for periods of up to 7 days. Briefly, the skin will be swabbed with a disinfectant and a small catheter will be inserted subcutaneously. This needle will be attached to a glucose sensor. Patients will wear this sensor for 6 days. Patients will measure their glucose using a glucometer 4 times each day during this period and will also be given a log book to keep track of glucose values. Patients will also be asked to record any symptoms of hypoglycemia. At the end of 6 days the sensor will be removed.
At the same time the glucose sensor is started, a trained research nurse will connect the patient to a single use CardioSTAT ECG recorder. The archived ECG waveforms will be downloaded for QT and T-wave alternans analysis. The heart rate and QT interval will be measured at baseline and the end of each interval from the digitized ECG.
Patients and relevant family will be provided with in person education regarding the function and use of the monitor, implications for bathing and sleep, and contact information for troubleshooting. Patients will be asked to change the leads at home twice during the 6 days of the study. Patients will be asked to keep a log book of any cardiac symptoms during the 6 days of the study, as well as their activities. The glucose and CardioSTAT monitor will undergo time synchronization to ensure ability to do correlative analysis.
This is a feasibility pilot to establish preliminary data for analysis. The CardioSTAT monitor will allow assessment of cardiac arrhythmias, myocardial ischemia and cardiovascular autonomic function. The results from the glucose sensor and the CardioSTAT monitor will be correlated and compared to each other to determine if hypoglycemia has an adverse effect on heart function. Hypoglycemia is likely to induce autonomic responses captured on the CardioSTAT monitor and concordant ischemic S-T segment changes if coronary disease is present. It may also detect any resultant arrhythmias, although ischemic arrhythmias are uncommon in 6 days of monitoring. If investigators determine that hypoglycemia has negative effects on cardiac function, investigators may able to design treatments that would prevent these effects from happening in the future.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Impact of Hypoglycemia on Cardiac Function in Elderly Patients With Diabetes|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
- blood sugar measurement [ Time Frame: 6 days ]Track hypoglycemia with continuous glucose monitor
- Monitor cardiac function [ Time Frame: 6 days ]Track alterations in cardiac rhythm, alterations in cardiovascular autonomic function and myocardial ischemia, collect baseline data to design a subsequent study to assess the effects of various interventions designed to protect the cardiovascular system against hypoglycemia.
- Correlation [ Time Frame: 6 days ]Try to correlate blood sugar (hypoglycemic events) and cardiac function (alterations in cardiac rhythm, alterations in cardiovascular autonomic function and myocardial ischemia).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01980914
|Contact: Boris Feldmanemail@example.com|
|Canada, British Columbia|
|Vancouver Coastal Health Research Institute (VCHRI/VCHA) site -Vancouver General Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V6M 1N7|
|Contact: Boris Feldman 604-875-5115 firstname.lastname@example.org|
|Principal Investigator: Graydon S Meneilly, MD|
|Sub-Investigator: Kenneth M Madden, MD, MSc|
|Sub-Investigator: Andrew D Krahn, MD|
|Principal Investigator:||Graydon S Meneilly, MD||University of British Columbia|