An observational study in Diabetes, Sarcopenia and Hypotension, Orthostatic, sponsored by Kenneth Madden. Withdrawn at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-01-12.
Sponsored by Kenneth Madden · Observational
In this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia
Diabetes is common in the elderly. By the age of 70, approximately 25% of the population has diabetes and another 25% is at risk for diabetes. Elderly patients with diabetes are at increased risk for disability and reduction in their instrumental and basic activities of daily living. The prevalence of frailty is higher in people with diabetes that with age matched controls without diabetes. One of the major contributing factors to frailty is sarcopenia.
Insulin is an important anabolic hormone that prevents protein breakdown and to a lesser extent stimulates protein synthesis. There is some evidence that the ability of insulin to stimulate anabolic processes may be reduced in diabetes.
Insulin has cardiovascular properties, resulting in simultaneous adrenergic and vasodilatory responses that have opposing influences on blood pressure. Epidemiological studies have demonstrated that the use of insulin is a risk factor for syncope.
The investigators will study 30 older adults age 65 and older with type 2 diabetes who have never taken insulin to manage their diabetes but now need insulin to manage their diabetes. Data will be compared pre insulin start and 3 and 6 months after starting insulin.
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
Browse Sarcopenia studies →Kenneth Madden is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Older adults age 65 and older with type 2 diabetes who do not use insulin to manage their diabetes.
Exclusion Criteria:
Study participants will be tested prior to and 3 and 6 months after starting insulin to manage their diabetes
Drug: Insulin Lispro
Insulin
Also known as: Humalog
Body composition
Measured by DEXA Scan
Time frame: Change from months 0, 3 and 6 months post insulin start
Grip strength
measured by Hand Dynamometer
Time frame: Change from months 0, 3 and 6 months post insulin start
Physical functioning Survey
measured by the Physical Component Summary from the SF-12 Health
Time frame: Change from months 0, 3 and 6 months post insulin start
Presence or absence of orthostatic hypotension
Drop in systolic blood pressure of greater than 20 mmHg after 3 minutes of standing
Time frame: Change from months 0, 3 and 6 months post insulin start
Nadir of systolic blood pressure during the Tilt Table Test
Lowest systolic blood pressure obtained during the Tilt Table Test
Time frame: Change from months 0, 3 and 6 months post insulin start
Nadir of diastolic blood pressure during the Tilt Table Test
Lowest diastolic blood pressure obtained during the Tilt Table Test
Time frame: Change from months 0, 3 and 6 months post insulin start
Nadir of middle cerebral artery velocity as measured by transcranial doppler
Lowest middle cerebral artery velocity obtained during the Tilt Table Test
Time frame: Change from months 0, 3 and 6 months post insulin start
Presence or absence of a positive Tilt Table Test (vasovagal syncope)
Sudden drop in blood pressure and heart rate that leads to fainting
Time frame: Change from months 0, 3 and 6 months post insulin start
Plan to share: No
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Kenneth Madden