Effects of Insulin on Hypotension and Sarcopenia

Study Overview
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Brief Summary
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In this study investigator's aim to determine the impact of insulin therapy on hypotension and sarcopenia

Detailed Description
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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.

Official Title
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Effects of Insulin on Hypotension and Sarcopenia

Conditions
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Diabetes, Sarcopenia, Hypotension, Orthostatic

Intervention / Treatment
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* Drug: Insulin Lispro


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 Diabetes, Insulin Naive<br>Study participants will be tested prior to and 3 and 6 months after starting insulin to manage their diabetes | Drug: Insulin Lispro<br>* Insulin<br>* Other names: Humalog;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Measured by DEXA Scan | Change from months 0, 3 and 6 months post insulin start | 
| Grip strength | measured by Hand Dynamometer | 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 | 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 | 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 | 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 | Change from months 0, 3 and 6 months post insulin start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nadir of middle cerebral artery velocity as measured by transcranial doppler | Lowest middle cerebral artery velocity obtained during the Tilt Table Test | 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 | Change from months 0, 3 and 6 months post insulin start | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Sarcopenia, Hypotension, Tilt Table Test