INTRODUCTION

We would like to invite you to be part of a research study in the Department of Kinesiology. Before you decide if you would like to participate, we want you to know why we are doing the study. We also want you to know about any risks (anything unexpected that might happen) and what you will be expected to do in the study.

The study personnel will talk to you about the study and answer any questions you have. We will ask you to sign this form to show that you understand the study. We will give you a copy of this form to keep. It is important that you know:

• You do not have to join the study;

• You may change your mind and stop being in the study any time you want.

This study requires 3 visits to the lab and only one blood sample.

PURPOSE OF STUDY: In this research study, we are interested in metabolic syndrome and factors that cause it. Metabolic syndrome is a term used to describe a group of health factors that together put an individual at risk to develop more significant health concerns, such as heart disease, diabetes, lung disease and cancer. Metabolic syndrome includes the following health factors: obesity, cholesterol levels, blood levels such as glucose (or sugar) as well as blood pressure. Although we know that inactivity and eating high caloric food plays a role in the development of obesity and the other metabolic disease indicators, we also believe that genes play a role. Therefore, this study will examine why individuals have this increased risk by looking at: fitness, metabolic syndrome contributing factors, family history, and genes. By knowing this, we hope to develop ways of changing this increase risk in the future.

You are being invited to participate in this study because you are between the ages of 18-35 years of age, are not a diabetic and meet the exclusion criteria discussed below.

Exclusion Criteria: You will be excluded from participating in this study if:

(1) you show evidence of diabetes or diabetes-like problems

(2) you use glucocorticoid (steroids) or appetite suppressants

(3) you use drugs known to alter glucose metabolism, Metformin, thiazolidinediones, sulfonylurea receptor agonists and inhibitors of alpha-glucoside hydrolase; other medications known to alter blood levels being tested in this study

(4) you are unable to provide the requested fasting blood sample

(5) you are a female subject who is pregnant by self report

(6) you are unable to provide informed consent / assent

(7) you have previous diagnosis or treatment for hematologic-oncologic (blood) disorder

(8) you have a history or current treatment for an eating disorder

(9) you are being treated for weight loss

(10) you have a history of bariatric (obesity related) surgery

(11) you have a history of neurosurgical procedure

(12) you are currently participating in another clinical trial involving an investigational drug

(13) you have a history of psychiatric disorder, which in the opinion of the investigator would

affect the conduct of the proposed study.

PROCEDURES

You will be asked to meet with the research team a total of three times. Each visit will take approximately 1-2 hours.

Visit one: Personal Health Information- After you have read and signed this consent form, you will be asked to complete some brief questionnaires. These questionnaires include a family history questionnaire to assess if there is a history in your immediate family of metabolic syndrome or related health conditions, and ancestry, dietary, and physical activity questionnaires as well a questionnaire about your personal views of your health. We will also take your blood pressure twice during this visit.

Prior to visit two: You will be instructed on what is needed the night and morning before your second visit. You will be asked to not eat or drink (except water) for 12 hours before visit two.

Visit two: Your height, weight, and waist circumference (with a tape measure) will be measured, blood pressure will be measured twice, and a blood sample will be taken. The blood draw will be scheduled in the morning as to allow you to eat shortly after the visit. You will also be asked to provide 35mL (or about seven teaspoons) of blood. Your blood will be tested for sugar (glucose), cholesterol levels (lipid profiles), insulin levels, and other factors (such as C-reactive proteins, hemoglobin A1-C) found in the blood that may be important factors in metabolic syndrome or related health problems. We will also use the blood to do genetic analysis. Genetic analysis involves looking at your genes, or “recipes” that tell your body how to work. These genes (recipes) are made up of four letters (called DNA), which spell out a meaningful code. These differences in the individual letters can sometimes change the message of the instructions.

A portion of your blood sample will be sent to Quest Diagnostics Laboratory for testing of the metabolic syndrome indicators and another portion will be sent for genetic analysis to Dr. Eric Hoffman’s laboratory in Washington, DC at Children’s National Medical Center. Each sample will be labeled with a unique identifier which does not include any identifying information to protect your privacy.

Results from genetic testing performed as part of this study will not be reported to you. Providing a blood sample for a study of genetics may cause you some anxiety related to the use and storage of genetic information. However, none of the information obtained through genetic testing will be released to you, your physician, or your insurance company.

You will receive results of your blood test for the following:

Glucose (sugar)

Insulin

C-reactive Proteins

Lipid profile (cholesterol levels)

If these blood results suggest to us that you might be in a moderate to high risk category (as determined by the American Heart Association/American College of Sports Medicine Risk criteria), you will not be able to participate in the VO2 max test and will be referred to your own health care provider.

You will not receive results from the genetic testing.

Once the study personnel have looked over results of your blood tests and questionnaires (approximately within 4 wks from visit two), you will be contacted by phone by the study personnel. During this discussion you will be given the results of the blood tests mentioned above.

You will be not asked to return to do the fitness test (VO2max) if we identify increased risk factors. You will be given the results over the phone and advised to speak with your physician further about these results.

We will ask you if you would like your results (except the genetic tests) sent to your physician. For us to send your results to your physician, you must request and complete a medical release form stating that you want us to do this and provide your physician’s information.

Visit Three: Fitness test (VO2max): The last part of the study is a fitness test, called a VO2 max test. You run on a treadmill during and the investigator will gradually increase the intensity of the exercise. During this test, the oxygen and other gasses you breathe in and out will be measured. You will breath out of your mouth into a tube connected to a machine that measures these gases. You will be asked to run on the treadmill until you feel that you cannot run any longer. At that point you will signal the investigator who will immediately stop the test.