A RAGE of AGE in Aging (Diabetes)

RAGE Study Participant Login

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If you are interested in participating in our research, please contact:

1) Email: gwiresearch@georgetown. edu

2) Email: cfsresearch@georgetown. edu

3) Phone: 202-687-8231

Introduction

You are invited to consider participating in this study. The study is called A RAGE for AGE in Aging. Please take your time to make your decision. Discuss it with your family and friends. It is important that you read and understand several general principles that apply to all who take part in our studies:

1. a.Taking part in the study is entirely voluntary
   

2. b.Personal benefit to you may or may not result from taking part in the study, but knowledge may be gained from your participation that will benefit others
   

3. c.You may withdraw from the study at any time without any of the benefits you would have received normally being limited or taken away.
   

The purpose and nature of the study, possible benefits, risks, and discomforts, other options, your rights as a participant, and other information about the study are discussed below. Any new information discovered, at any time during the research, which might affect your decision to participate or remain in the study will be provided to you.   You are urged to ask any questions you have about this study with the staff members who explain it to you. You are urged to take whatever time you need to discuss the study with your physician, hospital personnel and your family and friends.   The decision to participate or not is yours.   If you decide to participate, please sign and date where indicated at the end of this form.

The research is being sponsored by Dr. Baraniuk until new funds are available to support this study. James N. Baraniuk, M. D. from Georgetown University, Washington, DC, is the primary investigator.

Why is the study being done

You are being asked to participate in this observational study because you may have diabetes, or are the same gender and general age of the diabetic people who are taking part in this study.

You may not participate in this study if any of the following apply to you (reasons for exclusion from the study):

1. 1.Other chronic illnesses that may interfere with the results of this diabetes study.
   

2. 2.HIV or hepatitis B viral infections.
   

3. 3.Endocrine diseases except for well controlled thyroid disease.
   

4. 4.Neurological problems such as dementia, inflammation (e. g. multiple sclerosis), or other significant brain conditions.
   

5. 5.Problems with blood coagulation including the use of coumadin or Plavix.
   

6. 6.Inflammatory bowel disease.
   

7. 7.Cancer.
   

8. 8.You cannot complete the English language questionnaires
   

9. 9.You are in jail (incarcerated).
   

10. 10.You are age 20 years or younger.
    

11. 11.You have fears, concerns, or other problems with giving blood (e. g. hard to draw blood sample).
    

12. 12.You do not want to have any genetic testing done using your DNA.  
    

If you are a diabetic subject with a kidney transplants and are taking transplantation medications, then you will be able to participate, but Dr. Baraniuk and his team will not be able to perform all of the tests that are planned. Your questionnaire and genetic tests will be very important, since one of the tests may help predict which diabetics develop kidney failure and need dialysis or transplantation. It will be very important to tell the study team the names of your drugs and their doses in order to determine if some of your complaints are caused by these drugs rather than the diabetes or its complications.

1. (A)The purpose of this study is to learn about the natural history of diabetes by studying (a) the ways that high blood sugar levels can alter blood proteins, and (b) determine if a short region of your DNA could determine how severe your diabetes could become.
   

2. (B)This research is being done to gather new information about the effects of diabetes on the heart and blood vessels (atherosclerosis), kidney (diabetic nephropathy), eye (diabetic retinopathy), and blood proteins. Differences between groups of diabetics and healthy subjects may give information about ways that high blood sugar levels damage tissues. The blood test information may provide clues to new, more effective treatments.
   

The DNA (genetic) test will sequence a short stretch of your DNA. German investigators have found that changes in this region predicted which diabetics would develop severe kidney disease. Dr. Baraniuk will sequence only this short segment of your DNA to determine if the German study is correct.

A hand held device will be used to apply pressure to 18 points on your body. You will say when the pressure becomes painful. This will help determine how your pain nerves are working.

You will be asked to complete an extensive questionnaire about pain, activity, sleep, your personal perceptions, the quality of your life, and other aspects of daily living. Your results will be added to those of over 600 other people to determine if there are differences between diabetics and people with other types of illnesses.

All of this information will be collected in a confidential manner so that it will not be possible to identify your personal results. This will protect your identity. It will also mean that you will not be able to learn your personal results for any of the studies. Protection of your identity and maintenance of your confidentiality will be ensured by labeling all samples with anonymous identification codes that can not be traced back to your hospital or any personal information.