Baraniuk Lab

 

CNDP1 in GWI

 
 

CNDP1 in GWI Study Participant Login

This link require a login and password for access. If you do not have a login or password, please contact us.

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 CNDP1 in GWI. CNDP1 is the abbreviation for an enzyme called carnosine dipeptidase 1. GWI is short for Gulf War Illness. You can participate if you were in the Armed Forces for at least 30 days between August 1, 1990 and July 31, 1991. You may also participate if you have Chronic Fatigue Syndrome (CFS) and were not in the military during those dates.


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 principal investigator (person in charge of this research study) is James N. Baraniuk, M.D.


The research is being sponsored by the Department of Defense (DOD). DOD is called the sponsor. Georgetown University is being paid by the DOD to conduct this study with James N. Baraniuk, M.D. as the primary investigator. The title of the study is CNDP1 in GWI.


This research study follows the directives of the U.S. Army Medical Research and Materiel Command (USAMRMC) Guidelines for Human Research (June 21, 2007) and its Guidelines for Investigators: Requirements for U.S. Army Medical Research and Materiel Command (USAMRMC) Headquarters Review and Approval of Research Involving Human Volunteers, Human Anatomical Substances, and/or Human Data under the guidance of the USAMRMC Human Research Protection Office (HRPO).


  1. 1.As a volunteer, you must be aware that representatives of the USAMRMC have the authority to review research records.

  2. 2.You have the right to decline to participate in this research study based on the DOD source of funding.

  3. 3.You may NOT participate if you are Active Duty Military.




Why is the study being done?


You are being asked to participate in this study because you were enlisted in the military for at least 30 days during the Persian Gulf War of August 1, 1990 to July 31, 1991. You may have developed Gulf War Illness (GWI) or be healthy (healthy veteran). Participants with and without Gulf War Illness will be compared to better define GWI. This will help discover new methods for diagnosis and treatment.




Reasons Why you may not take part in this study (Exclusion Criteria)


You may not participate in this protocol if any of the following exclusion criteria apply to you:


  1. 1.HIV / AIDS subjects will be excluded. This infection alters many of the tests that will be part of this study. Everyone will have an HIV test. If your HIV test is positive, Dr. Baraniuk and the study team will contact you immediately. You will be immediately referred to your local primary care physician, infectious disease or other medical facility for follow-up and to start treatment.

  2. 2.Pregnant women will be excluded because of hormone effects and the fatigue that is common in pregnancy. Every woman will have a pregnancy test.

  3. 3.    Active duty military personnel

  4. 4.Children will be excluded because they are not old enough to have participated in the Persian Gulf War.

  5. 5.Incarcerated people (in jail) will be excluded because it is not fair to include them in this research study.

  6. 6.Cognitive impairment (problems thinking; brain fog) can make it difficult to understand this informed consent form, the questionnaires, and how to perform other parts of this study. If you have problems like this, then you cannot be in this study. However, we recognize that problems concentrating, selecting the right word, and other issues are part of GWI. You will have an interview with Dr. Baraniuk who will decide if you can join the study or not. You will be able to take part if you have GWI but do not have another cause for a problem with thinking such as mental retardation, severe head injury, stroke, proven multiple sclerosis, melancholic suicidal major depression, schizophrenia, dementia, or other serious neurological cause. A Mini-Mental Status Examination will be administered. A cut-off score of ≥ 24 must be achieved to be part of this study.

  7. 7.Abnormal laboratory and questionnaire results. Everyone will complete questionnaires, have blood work and other tests. We have set limits for these studies of blood, kidney, liver, blood pressure, heart, psychological status, and other measures that will allow you to be recruited into the study (inclusion criteria). If your results are outside these limits (exclusion criteria), then Dr. Baraniuk will exclude you from the study. He and his study staff will help arrange for you to see your personal physician or another doctor to investigate abnormal test results.

  8. 8.Refusal to have CNDP1 and other gene testing. Everyone who participates in this study will have a test of their CNDP1 gene. This is a genetic test of a very short piece of your body’s genetic material. We will determine if you have the usual short version or one of the long versions of this gene. This result will be important because we will test to see if people with the long version have different test results compared to those with the short version. Cheek swabs are used to obtain the genetic material. Samples will also be obtained so that other similar genetic tests can be done. These results will also be used to separate GWI from healthy control subjects to see if these gene changes are found more often in GWI than healthy veterans.



The purpose of this study:


The purpose of this study is to compare several characteristics between GWI and healthy veterans. These characteristics include which version of CNDP1 gene you have, hand grip strength, blood tests, questionnaire answers, and other test results. Significant differences will help define the reasons who some people develop GWI. This is an observational study to learn about the differences in health between subjects with GWI and healthy veterans who do not have GWI.



Why is this clinical research study design being used?


This research is being done because there is still a lot of confusion about the causes and long term effects experienced by veterans of the Persian Gulf War of 1990 to 1991. Most of the research studies that have been published have focused on differences in responses to questionnaires. We are taking a different approach.



Long and Short versions of the CNDP1 gene.


Genes are the genetic memory material that code for proteins. Proteins carry out the functions of the body. About 99% of the genetic material is the same in all humans. However, we have identified one potential genetic difference between veterans who have GWI and healthy veterans. We propose that a difference in a gene called CNDP1 may be a risk factor for developing GWI. CNDP1 is the protein that breaks down the body chemical called carnosine. If there is too much CNDP1, then the carnosine is broken down too fast. This may be bad, since carnosine is very important for protecting the brain, eyes, kidneys and muscles from damage. The CNDP1 protein produced by the long versions of the CNDP1 gene may break down the protective carnosine very quickly. We propose that this may lead to more tissue damage when compared to the lower amount of CNDP1 protein produced from the short CNDP1 gene. Therefore, we think that GWI subjects will have more people with the long form of CNDP1 than the healthy veteran group.