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Informed Consent Form Study ID: HUM00039723 IRB: IRBMED Date Approved: 11/8/2018 Expiration Date: 11/7/2019 UNIVERSITY OF MICHIGAN CONSENT TO BE PART OF A RESEARCH STUDY INFORMATION ABOUT THIS FORM You may be eligible to take part in a research study. This form gives you important information about the study. It describes the purpose of the study, and the risks and possible benefits of participating in the study. Please take time to review this information carefully. After you have finished, you should talk to the researchers about the study and ask them any questions you have. You may also wish to talk to others (for example, your friends, family, or other doctors) about your participation in this study. If you decide to take part in the study, you will be asked to sign this form. Before you sign this form, be sure you understand what the study is about, including the risks and possible benefits to you. 1. GENERAL INFORMATION ABOUT THIS STUDY AND THE RESEARCHERS 1.1 Study title: The impact of metabolic syndrome on the incidence of neuropathy in obese subjects. 1.2 Company or agency sponsoring the study: A. Alfred Taubman CA&UP Administration American Diabetes Association Impeto Medical Neurology Department Department of Health and Human Services, National Institutes of Health 1.3 Names, degrees, and affiliations of the researchers conducting the study: Dr. Brian Callaghan, M.D. Principal Investigator Dr. Charles Burant, M.D., Ph.D. Co- Investigator Dr. Eva Feldman, M.D, Ph.D. Co- Investigator Dr. Rodica Pop-Busui, M.D. Co- Investigator Dr. Amy Rothberg, M.D. Co- Investigator Dr. Ann Little, M.D. Co-Investigator Dr. James Teener, M.D. Co-Investigator Dr. Henry Paulson, MD, PhD Co-Investigator Dr. Bruno Giordani, PhD Co-Investigator Dr. James Richardson Consultant Bin Nan, BS, MS, Ph.D. Consultant Emily Villegas-Umana, RN, BSN Study Coordinator/Project Manager Ericka Chant, MPH Study Coordinator/Project Manager Jayna Duell, RN, BSN Study Coordinator/Project Manager Carey Backus, B.A. Staff Crystal Pacut, B.S. Staff 2. PURPOSE OF THIS STUDY 2.1 Study purpose: The purpose of our study is to show that obesity and its associated medical problems affect how likely an individual is to develop peripheral neuropathy. Neuropathy is nerve damage which often causes numbness, pain, and tingling, usually beginning in the feet. The problems associated with obesity that we are interested in studying for this study include excess fat (especially around the mid-section), problems with cholesterol and Consent Subtitle: Obese Subject Page 1 of 11 Consent Version: VI Study ID: HUM00039723 IRB: IRBMED Date Approved: 11/8/2018 Expiration Date: 11/7/2019 triglycerides (fat in the blood), high blood pressure, diabetes and other problems with your body’s processing of sugar and insulin. These factors together are referred to as the metabolic syndrome. Thin participants of the same age and gender without any factors of the metabolic syndrome will also be included in this study to see if they are less likely to develop neuropathy than individuals with obesity and other factors of the metabolic syndrome. 3. INFORMATION ABOUT STUDY PARTICIPANTS (SUBJECTS) Taking part in this study is completely voluntary. You do not have to participate if you don't want to. You may also leave the study at any time. If you leave the study before it is finished, there will be no penalty to you, and you will not lose any benefits to which you are otherwise entitled. 3.1 Who can take part in this study? You may be included in the study if: You are at least 18 years old and are able and willing to provide written informed consent for the study. You are enrolled in the Investigational Weight Management Clinic (IWMC). This is the weight management program through the Department of Endocrinology which is helping you to lose weight. You are enrolled in the IWMC’s associated research study (HUM00030088) called “Identification of phenotypic factors that predict success for weight loss and long-term weight maintenance” and agree to be contacted regarding other studies related to obesity. You may not be included in the study if: You are taking any blood-thinning medications (anti-coagulants), other than aspirin. You are not participating in the IWMC and/or its associated research study (HUM00030088), either due to lack of interest or because you were not eligible to participate. 3.2 How many people (subjects) are expected to take part in this study? Up to 400 obese participants and 200 thin participants are expected, for a total of up to 600 participants. 4. INFORMATION ABOUT STUDY PARTICIPATION 4.1 What will happen to me in this study? The following will occur at the beginning and end (2 years after study initiation) time points of the study. We will be repeating all of the testing after two years to see how your weight loss, increased exercise, and/or the passage of time will affect each of these measures. We will test for any changed in the nerves that surround your heart by recording your heart rate, blood pressure, and breathing at rest compared to during a regulated breathing exercise, when you stand up, and when you blow into a mouthpiece. This takes about 60 minutes to complete and is called Heart Rate Variability testing. You will lie flat and quietly for 20 minutes before the recording begins and must follow special preparation instructions for this test provided by the study coordinator. We will apply a small electric current to the skin at the ankle, knee, wrist and elbow in a test called Nerve Conduction Studies. This feels similar to a static shock and is used to measure the health of the nerve being tested. This will take 30-45 minutes to complete. We will measure how much you seat which will tell us about how much your body’s system is able to control your sweating. This body system is called your autonomic nervous system. We will use two tests to measure your sweat function, the QSART and the SUDOSCAN tests. o During the QSART test, plastic straps will be used to secure a small capsule to the forearm, knee, ankle and foot. A liquid solution called acetylcholine will be put into the capsules so that it touches that skin Consent Subtitle: Obese Subject Page 2 of 11 Consent Version: VI Study ID: HUM00039723 IRB: IRBMED Date Approved: 11/8/2018 Expiration Date: 11/7/2019 and causes it so sweat. Your sweat output beneath the capsules is then measured. This takes about 20 minutes to complete and often causes a “pins and needles” sensation. o You will be asked to complete a SUDOSCAN test, unless you have an embedded pacemaker or defibrillator. The SUDOSCAN device will be used to measure your how well your skin produces sweat. You will be asked to place your bare hands and feet on stainless-steel electrode plates, and a Direct Current of less than 4 volts total will stimulate your sweat glands. This is a fast, 3-minute, non-invasive, pain-free test that will scan the soles of your feet and the palms of your hands. You will be instructed to take off your shoes and socks and roll up your pants, shirt sleeves, remove any large obtrusive jewelry and wash off lotion. You will be examined by a neurologist who specializes in nerve and muscle problems, including neuropathy (neuromuscular specialist). He/she will ask you some questions about yourself, any medical problems that you may have, any symptoms that are consistent with neuropathy, and do a brief physical examine. The examine will include things such as checking your reflexes; checking how well you can feel vibration, cold, and pinprick sensations; watching you walk; and looking at your feet for any signs of neuropathy. He/she will complete the Michigan Neuropathy Screening Instrument which includes 15 questions about nerve symptoms and a neurologic examination, as well as a standardized Neurological Exam form geared towards assessing neuropathy. You will be asked to complete some questionnaires as part of participation in the study. This will be completed either at home before your study visit or at the time of the visit, as instructed by the study coordinator: o A neuropathy-specific quality of life questionnaire named NeuroQoL. This questionnaire will assess if and how symptoms of neuropathy have affected your quality of life. This will take about 15 minutes to complete. o The McGill Pain Questionnaire. This questionnaire assesses the level of pain that you experience in your feet. This should take less than 5 minutes to complete o Two surveys related to symptoms that appear if you may have problems with the nerves which control the autonomic system. The autonomic system is the body system which controls muscle function which you do not have direct control over, such as your heart and digestion. The surveys are called the Survey of Autonomic Symptoms and Autonomic Symptoms Profile and may take you up to 15 minutes to complete. o A brief eight question survey to assess risk for obstructive sleep apnea, called the STOP-BANG questionnaire. You will be asked to stand on one foot for a period of time to evaluate any problems with balance that you may because balance can be affected in individuals with neuropathy. You will also be asked lie on your side and raise your hips from the ground and maintain this position. This is called a plank test will be informative regarding how abdominal or hip strength may affect balance. We will measure how well you can feel cold and vibration sensations in your feet because these sensations are often reduced in individuals with neuropathy.
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