Lean and overweight children sought for study

(Sept. 24, 2009) The Health Influences in Puberty “HIP” study is seeking lean and overweight children -- at least 9 years old and in early puberty –- for a study on insulin resistance.

The study:

1. Involves a screening visit, two long visits in a period of two years and several short visits.
2. Questionnaires, and a blood draw at the outpatient Endocrinology Clinic at The Children’s Hospital
3. Oral glucose tolerance test

Study subjects will be compensated for their time.

Principal Investigator: Megan Kelsey, MD; COMIRB:07-0988. Information: kelsey.megan@tchden.org, 720-777-0991; Study Coordinator: Teresa Witten witten.teresa@tchden.org.

Sleep-wake patterns of mothers and children

(Sept. 24, 2009) Mothers of healthy children (ages 3 to 12) are being recruited to see if sleep is different between mothers of healthy children and mothers of children with leukemia. (Mothers of children with leukemia will be recruited from Children’s Hospital.)

We are looking for mother and child pairs:

Mothers:

1. 21 years of age or older
2. Primary caregiver for the child
3. Speak and write English

Children:

1. Between 3 and 12 years of age
2. No chronic illness or disability
3. Able to wear a watch for 7-8 days

Participants will:

1. Complete questionnaires in your home or other place that is convenient. This will take 45 to 60 minutes.
2. Collect saliva samples for salivary cortisol by placing a piece of filter paper on your tongue for 10 seconds four times a day for 3 consecutive days. Cortisol is a substance that shows how  one’s body adapts during times of stress and when at rest. 
3. Wear a watch that measures sleep for about 7-8 days. This watch is lightweight and the size of a standard watch.
4. We will ask children to wear a watch that measures their sleep for about 7-8 days.

Compensation is provided. Information: Madalynn Neu, RN, PhD 303.724.8550 or Ellyn Matthews, RN, PhD, AOCN 303.724.8552. E-mail: madalynn.neu@ucdenver.edu, ellyn.matthews@ucdenver.edu. COMIRB # 08-1354.

Pregnant women sought for behavior study

(Aug. 10, 2009) Pregnant women are invited to take part in a project to help up better understand health behaviors of women during pregnancy.

Participants must be:

• Women who are currently in their second or third trimester of pregnancy

• English speaking

• 18-46 years of age

• Not experiencing a ‘high-risk’ pregnancy

What is involved:

• Participants will participate in a focus group discussion for 1 to 1 ½ hours

• Participants will also complete a brief survey regarding thoughts about physical activity.

Compensation will be provided.

This study is funded by the Centers for Disease Control and Prevention. If you are interested, contact Katie Moseley at 303.916.3448 or kathleen.moseley@ucdenver.edu, Principal Investigator: Jenn Leiferman, PhD. COMIRB #07-0862

Children needed for study on lupus

(Aug. 3, 2009) The University of Colorado Denver is looking for healthy children over the age of 8 to participate in a research study investigating the cause of lupus. Volunteers will be asked to donate a small amount of blood at five successive three-month intervals.

Eligibility is limited to children who have no personal history of autoimmune diseases or chronic infections. There should also be no history of autoimmune diseases in the family.

Compensation for participation will be provided.

If interested contact Kara McCoy at 303-724-7522 or by email at kara.mccoy@uchsc.edu. COMIRB #03-833, Principal Investigator: Susan A. Boackle, MD; Co-Investigator: Jennifer Soep, MD.

Children needed for breakfast study

(July 22, 2009) The University of Colorado Denver is currently recruiting children age 8-13 for a research study to look at how the body handles a breakfast meal.

Screening assessments will include:

• a health and physical examination

• 2 blood draws; 2 hours between each blood draw

If you qualify to continue to participate in the study, based on the screening results, you will then complete the following tests over a 2 week period:

• measurement of your muscle and body fat content by DEXA

• measurement of how much energy your body uses when you are resting

You will then participate in the main part of the study. This will require you to participate in one test day. For three days before the test day, we will provide you with all your food and we will ask you not to play any sports or be very active. The night before the test day you will stay overnight in the Clinical Translational Research Center at The Children’s Hospital. The test day will include:

• Ultrasound measures of blood vessel health, three times on the study day

• Drawing of several blood samples from a small tube placed in a forearm vein on the study day.

The test day will last approximately 7 hours.

Compensation will be provided upon completion of the study.

COMIRB No. 07-0521; Principal Investigator Teresa Sharp, PhD. Contact Coordinator: Cherith Gordon at 303-724-3309 or cherith.gordon@ucdenver.edu.

Macrovascular disease in adolescents with type 1 diabetes

(July 10, 2009) The purpose of this research study is to assess risk for cardiovascular disease in adolescents with and with out type 1 diabetes.

Eligibility criteria:

• Adolescents with type 1 diabetes between the ages of 12-19 years for at least 5 years and no other serious medical problems.

• Adolescents without diabetes between the ages of 12-19 who have no serious medical problems.

Benefits: There are no expected benefits to participating.

Compensation: Subjects who participate in the study will receive compensation for the blood draw after an overnight fast, urine collection, vital signs and measurements.

For further information contact Franziska Bishop at 303-724-6764 or email, franziska.bishop@uchsc.edu. Paul Wadwa, MD, Principal Investigator. COMIRB Protocol 07-0780.

EAGeR study for Women who have had pregnancy loss and want to try again

(June 5, 2009) Available information shows that low-dose aspirin (LDA) might improve pregnancy outcomes. LDA appears to be safe and has few side effects. In this study, we will study the effects of LDA taken before pregnancy and continuing through week 36 of pregnancy.

Can I participate?

1. If you are between 18-40 years old,
2. have had ONE or TWO pregnancy losses in the past,
3. and want to become pregnant again, you may qualify for this very important study. Please contact us.

What will I need to do if I join the EAGeR study?

1. You will meet with a research nurse or staff once or twice a month.
2. We will ask you questions about your past and present medical and reproductive history.
3. We will take some simple measurements on you such as weight and height.
4. We will collect and test a small amount of your blood and urine at your visits.
5. You will take a daily folic acid pill along with a daily LDA pill or a placebo (a pill that contains NO medication).
6. You will collect and freeze a small amount of your urine each morning for two to three months. We will provide the supplies.
7. You will complete a short daily diary, which we will provide, for up to two months.
8. You be provided with a home fertility monitor to use throughout the study as well as home pregnancy tests.

What if I become pregnant?

1. You will continue to take your study pills.
2. We will provide you with an additional ultrasound early in your pregnancy.
3. We will keep in regular contact with you throughout your pregnancy.
4. You will collect and freeze a small amount of your urine each morning and complete a daily diary for one month.
5. We will get your permission to collect information about you and your baby from medical records.
6. You will continue to see your personal obstetrician as usual.

Are there risks?

1. There are small risks such as pain and bruising from the blood draw.
2. There are no known risks to you or your baby of LDA in the first 36 weeks of pregnancy.
3. If you have any side-effects, we will discuss the problem with you and act appropriately.

Potential Benefits

1. Close medical evaluations.
2. Use of a fertility monitor supplied by the study.

You will be paid for your time and travel to study appointments.

Information: Phone: 303-724-3525. E-mail: eager.trial@ucdenver.edu.

Stress hormones during pregnancy

(June 1, 2009) At the University of Colorado Denver we are conducting a research study designed to determine how to best measure stress hormones during pregnancy and how to apply this information to identify and treat prenatal stress.

We are looking for volunteers who:

• Are women less than 17 weeks pregnant

• Are non-smoking

• Currently not taking any medications (other than prenatal vitamins, etc.)

Participants will be asked to:

• Read and sign a consent form

• Complete surveys about stressors in their life and their current mood

• Collect multiple at home saliva samples

• Attend 4 hair stylist visits to have hair samples collected

The first visit will last from 1 to 1 ½ hours explain the study and fill out initial questionnaires. The following visits include 4 trips to a hair stylist for hair sample collection, including a complementary haircut and style. At home saliva collection will also occur 6 times throughout the prenatal period and can be done at the participant’s convenience.

Salon level hair care (cut and style) from a local hair stylist and monetary compensation will be provided to participants for their time.

Principle Investigator: Kimberly L. D’Anna, PhD. COMIRB No. 09-0117. For more information contact Kimberly L. D’Anna, PhD, 303-724-6237 or kimberly.danna@ucdenver.edu.

Pregnant women who want support

(April 29, 2009) Pregnant women who want support are encouraged to participate in an 8-week health program with other pregnant women.

The program includes:

• Participation in safe and effective physical activity

• Information on health behaviors during pregnancy

• A chance to meet and connect with other pregnant women

Compensation will be provided. If you are interested in participating, contact the study coordinator at 303-724-4396 to learn more. COMIRB Protocol No. 08-1237. PI: Jenn Leiferman, PhD, University of Colorado.

Teen boys, youth who have anger control problems needed

(Feb. 2, 2009) Healthy teenage boys and children with anger control problems are invited to take part in a research study involving brain imaging in aggressive youth.

Healthy teen boys needed:

1. between 11-17 years old
2. in good health
3. free of medication
4. without serious medical conditions, metal implants, braces, or permanent metal retainers

Youth with anger management issues:

1. between 11-17 years old who get easily angered and strike back if teased or threatened
2. claim others are to blame if they get into a fight
3. tend to assume intentional harm from peers
4. without serious medical conditions, metal implants, braces, or permanent metal retainers

The study offers compensation for completing the program and all assessments. For more information please contact Leah Jappe at: imagingresearch@tchden.org. Principal Investigator Dr. Guido Frank. COMIRB No. 08-0208.

Teens using drugs needed for study

(Jan. 30, 2009) Teens using marijuana, tobacco or other kinds of drugs who have a difficult time paying attention and are easily distracted are encouraged to take part in a study.

The University of Colorado Denver and Adolescent Research Center are offering payment for time and travel to teenagers (13-19) with marijuana and tobacco problems (and possibly other drugs) and who are experiencing problems with attention and concentration (symptoms of Attention-Deficit Hyperactivity Disorder or ADHD).

Participants will receive state-of-the-art treatment (cognitive behavioral therapy) for substance use at no cost. Teenagers will be paid for their participation in a 16-week medication study for ADHD.

If you or someone you know would be interested in more information about this no cost treatment and paid study participation, call Ashley, Jill, Michelle or Julie at 303-935-5892, or email Ashley at Ashley.Myracle@ucdenver.edu.

The study principal investigator is Paula Riggs, MD, associate professor of psychiatry. COMIRB: 08-0178

Breast feeding through 10 months

(Jan. 8, 2008) Women who have a new baby that is less than 5 months old and plan on breast feeding (no formula) through the first 10 months might be eligible for an infant nutrition study by researchers in the Section of Pediatric Nutrition at University of Colorado Denver School of Medicine and The Children’s Hospital. You must be planning on exclusively breast feeding for the first 5-6 months and to continue breast feeding (no formula) as you begin to add solid foods to the your baby’s diet through 10 months of age.

This study includes:

1. Exclusive breast feeding (no formula) through 10 months of age
2. Feeding your baby 1 of 3 randomly assigned diets
3. Monthly home visits (from ages 5-9 months) by a research team member
4. A single visit (at 9-10 months) to The Children’s Hospital of Denver for lab tests and procedures
5. Participation in a 9-day metabolic study, including urine, fecal and breast milk sample collections
6. An electric breast pump, monetary compensation, and baby food will be provided to participants.

If you are interested or have questions, please contact Diana Culbertson, MS, research coordinator, at 970-631-3627 (cell), 303-724-3248 (office) or Diana.Culbertson@uchsc.edu.

Overweight, pregnant women needed

(Dec. 15, 2008) Healthy, overweight women in their first trimester of pregnancy are needed for a study on “Dietary Habits And Blood Glucose Profiles In Non-Diabetic Pregnant Women.”

We are looking for:

1. Healthy women less than 15 weeks pregnant between the ages of 18-35
2. No prior history of diabetes BMI between 30-40 you may check this at: http://nhlbisupport.com/bmi/
3. Participants willing to wear a blood glucose monitor for two time periods during pregnancy
4. Participants willing to attend 6 visits for study related materials

Participants receive

1. Dietary analysis and counseling
2. Laboratory testing
3. Resting metabolic rate measurement Financial compensation

COMIRB 05-1134. Co-investigator Kristin Harmon MD. Pregnancy Study 303-315-9089 or eats.study@uchsc.edu  

Children needed for food use study

(Dec. 2, 2008) Children age 8-13 are needed for a research study looking at food use by the Body and resulting blood vessel health: how the body handles a breakfast meal.

Screening assessments will include:

• a health and physical examination

• 2 blood draws; 2 hours between each blood draw

If you qualify to continue to participate in the study, based on the screening results, you will then complete the following tests over a 2 week period:

• measurement of your muscle and body fat content by DEXA

• measurement of how much energy your body uses when you are resting

You will then participate in the main part of the study. This will require you to participate in one test day. For three days before the test day, we will provide you with all your food and we will ask you not to play any sports or be very active. The night before the test day you will stay overnight in the Clinical Translational Research Center at The Children’s Hospital. The test day will include:

• Ultrasound measures of blood vessel health, three times on the study day

• Drawing of several blood samples from a small tube placed in a forearm vein on the study day.

The test day will last approximately 7 hours. Compensation will be provided upon completion of the study.

COMIRB # 07-0521. Principal Investigator Teresa Sharp, PhD, contact Cherith Gordon cherith.gordon@ucdenver.edu or 303-724-3309.

Environmental, individual factors that influence children’s activity

(Nov. 21, 2008) The goal of Taking Neighborhood Health to Heart: Kids Project is to learn more about the health of children in these neighborhoods in the East Montclair, Northwest Aurora, Stapleton, and Park as it relates to physical activity. This is an extension of a project done in 2007 looking at the health of adults in the same neighborhoods.

The study involves the following:

1. Recruiting households in these neighborhoods with children living in the home between the ages of 10 and 14
2. The parent or guardian of the child and the child will each be asked to answer a short survey
3. The child will be asked to participate in some voluntary exercise tests similar to what is performed in school to measure physical fitness

For participating in the project, the household will receive one gift card. If you live in one of these neighborhoods and are interested in participating or would like more information about the study, please contact the study PRA Leah.M.Haverhals@ucdenver.edu  or call Kyla Krause at 303-399-2700 x 100 to see if you are eligible and to arrange an appointment to be interviewed in your home.

Principle investigator: Ira Gorman, PT, MSPH – HSRC Protocol 2008-131

Youth needed for pediatric research procedures

(Nov. 11, 2008) Researchers are looking for children and adolescents to participate in a study on pediatric research procedures.

Participants must be:

1. aged 11-14 years
2. accompanied by a parent

Participants will look at animated, video and word descriptions of two research procedures. The children will then answer a series of questions about the descriptions. The entire process will take about 1.5 hours.

Participants will receive a store gift card for their time. For more information, call 720-777-8529. Principal Investigator: Terri O’Lonergan; COMIRB # 08-0557.

Pregnancy and flu shot research

(Oct. 16, 2008) Pregnant volunteers are needed for a research study on immune responses to the flu shot during pregnancy.

Participant requirements:

* female in good health, less than 24 weeks pregnant (estimated delivery between November 2008 and July 2009)

* 15 to 55 years of age

* willing to attend six study visits

* no allergy to the vaccine products (eggs, neomycin)

Qualified participants will receive financial compensation.

For more information, contact Kelly Richardson at 303-315-0634 or kelly.richardson@uchsc.edu. Principle Investigator: Adriana Weinberg, MD; COMIRB# 04-0059.

Children’s nutrition study

(Oct. 9, 2008) Caucasian and Hispanic children aged 8-13 years are needed to participate in a research study looking at how the body breaks down food from a breakfast meal.

The research study involves three parts. First, researchers will perform screening assessments including a health and physical examination and two blood draws two hours apart.

Next, qualified participants will complete the following tests over a two week period:

*measurement of muscle and body fat content by DEXA

*measurement of amount of energy body uses when at rest

During the main and final test day, participants will stay overnight in the Clinical Translational Research Center at The Children’s Hospital. All food will be provided. Participants will be asked to refrain from physical activity. The main test day will last approximately seven hours, and will include:

*blood samples from a small tube placed in a forearm vein

*breath sampling via a plastic hood

*urine samples

Compensation will be provided upon the completion of these studies. For more information, contact Teresa Sharp at teresa.sharp@uchsc.edu or call 303-724-3309.

Principal Investigator: Tracy Horton, PhD; COMIRB # 04-0940.

Pregnant Hispanic women needed

(Oct. 1, 2008) The purpose of the study is to collect information about bile acid levels in the blood during pregnancy.

Bile acids are naturally occurring substances in the blood, but if increased in pregnancy, can cause health problems.

Study participant requirements:

ü   Healthy pregnant women planning on delivering at the University of Colorado Hospital

ü   Must be 16-24 weeks gestation at entry into study

ü   Obtaining pre-natal care at University of Colorado Hospital

Study entails:

ü   Three study visits with a blood draw (will try to coordinate with clinic appointment)

ü   Tests for Hepatitis B, C and D and HIV will be done if not part of your current health care

ü   Complete a short questionnaire

ü   Umbilical cord blood will be collected at delivery

ü   Compensation will be provided at each study visit

If interested, please contact one of the Perinatal Clinical Translational Research Center’s nurses at 720-848-6038 or e-mail donna.rodden@uchsc.edu.              

1. Sponsored by the Pediatric Clinical Translational Research Center, The Children's Hospital and University of Colorado Denver. COMIRB # 03-1001. Principle investigator: Adriana Weinberg, MD