Diabetes, Hypotension, Orthostatic, Sarcopenia
Conditions
Keywords
Diabetes, Sarcopenia, Hypotension, Tilt Table Test
Brief summary
In this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia
Detailed description
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.
Interventions
DRUGInsulin Lispro
Insulin
Sponsors
Kenneth Madden
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Inclusion criteria
* 65 years of age or older * Type 2 diabetes for at least 5 years * Insulin naive * now needs insulin to manage diabetes
Exclusion criteria
* anemia as defined by serum hematocrit * abnormal liver function tests * elevated serum creatinine * smoked within last 5 years * musculoskeletal or neurological condition that would preclude tilt table testing or orthostatic vitals * aortic stenosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nadir of diastolic blood pressure during the Tilt Table Test | Change from months 0, 3 and 6 months post insulin start | Lowest diastolic blood pressure obtained during the Tilt Table Test |
| Presence or absence of orthostatic hypotension | Change from months 0, 3 and 6 months post insulin start | Drop in systolic blood pressure of greater than 20 mmHg after 3 minutes of standing |
| Nadir of systolic blood pressure during the Tilt Table Test | Change from months 0, 3 and 6 months post insulin start | Lowest systolic blood pressure obtained during the Tilt Table Test |
| Body composition | Change from months 0, 3 and 6 months post insulin start | Measured by DEXA Scan |
| Grip strength | Change from months 0, 3 and 6 months post insulin start | measured by Hand Dynamometer |
| Physical functioning Survey | Change from months 0, 3 and 6 months post insulin start | measured by the Physical Component Summary from the SF-12 Health |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence or absence of a positive Tilt Table Test (vasovagal syncope) | Change from months 0, 3 and 6 months post insulin start | Sudden drop in blood pressure and heart rate that leads to fainting |
| Nadir of middle cerebral artery velocity as measured by transcranial doppler | Change from months 0, 3 and 6 months post insulin start | Lowest middle cerebral artery velocity obtained during the Tilt Table Test |
Countries
Canada
Outcome results
None listed