Mentoring to be Active: Peer Mentoring for Rural Appalachian Children to Reduce Overweight and Obesity

Official Title
Mentoring to be Active: Peer Mentoring for Rural Appalachian Children to Reduce Overweight and Obesity
Purpose

The purpose of this study is to lower the rate of type 2 diabetes in rural Appalachia youth due to obesity and/or being overweight. Our long-term goal is to improve the health of underserved, high-risk youth.

This study will test the effectiveness of the Mentored Planning to be Active + Family on physical activity outcomes and health outcomes among rural Appalachian middle school aged youth suffering from either overweight or obesity.

We have local high school-aged teen mentors work closely with middle school youth to increase social support, self-efficacy, and self-regulation skills to sustain physical activity and improve health before the children enter high school.

The peer mentoring is followed by a 6-month family reinforcement program.

Some parents will provide child assessment data of perceived child physical activity behaviors and child health.

 

Could this study be right for you?
  • Child has access to a computer or tablet device at home for virtual mentoring sessions/meetings
  • Child suffers from overweight or obesity - does not need to be under the care of a health care professional for this condition
  • Child and Parent able to participate read English at a 4th grade level. 
  • Family not expected to move from rural Appalachia within the 18 months. 
Age Range
12 - 13

A Study Evaluating Treatment for Intrahepatic Cholestasis of Pregnancy (ICP) - A liver disorder that can develop in pregnancy

Official Title
A Phase 2a/2b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in Adult Women with Intrahepatic Cholestasis of Pregnancy and Elevated Serum Bile Acid Concentrations (OHANA)
Purpose

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment intrahepatic cholestasis of pregnancy (ICP).

Depending upon how many weeks pregnant you are when you are screened at the first study visit, study participation could last up to 27 weeks

Could this study be right for you?

Inclusion Criteria:
• Females aged 18 to 45 years old
• Viable pregnancy of 20 weeks 0 days above
• Diagnosis of intrahepatic cholestasis of pregnancy (ICP)
• Willing and able to not use of any of the following for the duration of the study: statins, rifampin, bile acid sequestrants (e.g., cholestyramine), peroxisome proliferator-activated receptor (PPAR) agonists/fibrate drugs (e.g., fenofibrate, bezafibrate), S-adenosyl methionine.

Exclusion Criteria:
• Presence of triplets or higher multiple gestation
• Breastfeeding
• Alcohol use disorder or substance abuse within 12 months
• Known diagnosis of HIV infection or HIV antibody positivity

Exclusion Criteria varies, please contact Study Coordinator for more information.

Age Range
18 and up

A Study for Those With Type 2 Diabetes AND Who Are Experiencing Food Insecurity

Official Title
Linking Education, Produce Provision, and Community Referrals to Improve Diabetes Care (LINK)
Purpose

The purpose of this study is to improve hemoglobin A1c levels in patients with type 2 diabetes experiencing food insecurity.

The study will examine the effects of a produce referral program alone and in combination with other interventions. Our research is designed to develop a deeper understanding of how to provide patients with type 2 diabetes that are experiencing food insecurity with the resources, skills, and education to manage their health and social needs.

Could this study be right for you?

Inclusion Criteria:
- Age 18 years and older
- Type 2 diabetes based on American Diabetes Association Criteria
- Hemoglobin A1c level > 7.5%
- Worried about running out of food before you have money to buy more

Exclusion Criteria:
- Pregnant

A Study to Examine How Art Reduces Stress in People Who Suffer from Chronic Digestive Issues (ART-GUT study)

Official Title
Art to promote Reduction in stress, Truncate severity of Gastrointestinal symptoms Understand its role in Therapy (ART-GUT study)
Purpose

The purpose of this study is to evaluate whether group-art sessions can reduce stress, improve sleep quality, improve quality of life and decrease severity of digestive symptoms in participants who suffer from chronic digestive issues. Participants will meet virtually once per week for 1.5 hour sessions, via Zoom, and will be provided with art supplies.

The start date will be determined by the date the 1st session starts for a given group. Thus participants can be in the study for up to 14 weeks.

Could this study be right for you?

• Male or females aged 18 years or older
• Suffer from Chronic Digestive Symptoms
• Willing to meet virtually once per week for 1.5 hour group sessions

Age Range
18 and up

A Study to Help Improve Symptoms of Gastroparesis (BREATHE)

Official Title
Breathing Reduces Enteric symptoms and Anxiety promoting Therapeutic Healing Experience (BREATHE) – A Randomized Clinical Trial in Patients with Symptoms of Gastroparesis
Purpose

The purpose of this research study is to see if practicing mindful breathing daily can reduce stress, improve sleep
and possibly improve symptoms in patients with Gastroparesis.

Gastroparesis is a condition characterized by symptoms such as nausea, vomiting, feeling excessively full after eating a little bit, bloating and abdominal pain. One or more of these symptoms can be present in a given patient.

Your participation throughout the study will last 6 weeks.

Could this study be right for you?

• At least 18 years of age
• Able to read and understand English
• Has symptoms of gastroparesis for at least 6 months (gastric emptying study is NOT required for inclusion)

Age Range
18 and up

Metabolism Research Study--Healthy Volunteers Needed

Official Title
Adipocyte-T Cell Interactions Modulate Adipose Inflammation and Insulin Sensitivity Following Weight Gain
Purpose

The purpose of this research study is to better understand the role of fat tissue, how cells in fat tissue communicate, and determine what signals specific cells use to cause inflammation and insulin resistance during weight gain. This may help researchers better understand the process that happens in Type 2 Diabetes.

As a result, through the course of six--nine weeks, participants will be asked to gain at least 10% of their starting body weight. A dietitian will meet with participants to give advice to help with meeting the study weight gain goals, as well as provide additional meal vouchers and supplemental shakes as needed. Following the study, participants will receive guidance how to lose the weight they've gained if they would like to do that.

Could this study be right for you?

You may be eligible if you:
- Are 18-60 years of age
- Are lean; Have a BMI 18-24.9 kg/m2 (*see link below for calculating your BMI --Body Mass Index)
- Have healthy levels of cholesterol and triglycerides (These will be tested at screening)
- Are a non-smoker
- Are non-diabetic
- Are free of chronic illness
- Are not pregnant or breastfeeding

*If you want to calculate your BMI https://www.cdc.gov/healthyweight/assessing/bmi/adult_bmi/english_bmi_c…

Exclusion Criteria:
- Fasting triglycerides > 150 mg/dL or nonfasting triglycerides ˃ 250 mg/dl
- LDL-Cholesterol level > 150 mg/dL,
- Presence of significant anemia (hemoglobin <10.0 gm/dL),
- Currently or planning to take blood thinners ,
- Current smokers
- Have taken steroids or anti-inflammatory meds for >6 months in the last 6 months
- >10% body weight loss within 3 months of enrollment
*Other exclusions may apply

Age Range
18 and up

A Study for Those with Chronic Pancreatitis - The PROCEED Study

Official Title
Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies PROCEED Study)
Purpose

This study is done for researchers to understand pancreatitis and learn how the disease progresses naturally over time.

From the results of this study, researchers hope to develop some lab tests to support early diagnosis of chronic pancreatitis and to also discover any genetic factors that may affect your chances of developing chronic pancreatitis. The results of this study may also provide information that will open opportunities for new drug discovery.

Could this study be right for you?

• You have a history of acute or chronic pancreatitis OR
• You have experienced pain in your abdomen that a doctor has suggested could be due to pancreatitis
• You are between the ages of 18 and 75

Age Range
18 and up

A Study for Those with Chronic Pancreatitis

Official Title
A PHASE 1, SINGLE DOSE PK AND SAFETY STUDY WITH NI-03 FOLLOWED BY A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP DOSE-RANGING STUDY TO EVALUATE THE SAFETY AND EFFICACY OF NI-03 COMPARED TO PLACEBO IN SUBJECTS WITH CHRONIC PANCREATITIS
Purpose

The purpose of this study is to learn if a study drug called NI-03 (also known as Camostat) can help people with chronic pancreatitis. We want to find out what effects, good or bad, the study drug has on the disease. It has been approved in Japan and has been available by prescription for the treatment of the acute pain associated with chronic pancreatitis. The study drug will not be approved for sale in the United States until tests from studies like this one show that it is safe and effective.

Could this study be right for you?

-You are between the ages of 18-80
-You have a diagnosis of chronic pancreatitis
-For males: documented surgical sterilization, sexual abstinence, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required
-For females: documented surgical sterilization, sexual abstinence, postmenopausal status for at least 1 year, or agreed upon means of contraception from screening until 28 days after final dose of study medication is required

Age Range
18 and up

The REGENERATE Study - A study to evaluate the effectiveness and safety of a medication (Obeticholic Acid) for those with NASH (nonalcoholic steatohepatitis)

Official Title
A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis
Purpose

This research study is for those who have nonalcoholic steatohepatitis (NASH) (meaning your liver is swollen and damaged because of a buildup of fat in your liver) and some liver fibrosis (which is damaged and scarred liver tissue). Because of your condition, you may be eligible for a research study on an investigational drug for your condition. The Regenerate Study will assess the safety and effectiveness of the investigational medication obeticholic acid (OCA) compared to placebo in delaying specific medical conditions or health related issues that can occur in patients with nonalcoholic steatohepatitis (NASH) (meaning your liver is swollen and damaged because of a buildup of fat in your liver) and some liver fibrosis (which is damaged and scarred liver tissue).

Could this study be right for you?

- Age 18 or older
- Diagnosed with Stage 2 or 3 NASH (nonalcoholic steatohepatitis--meaning your liver is swollen and damaged because of a buildup of fat in your liver) and some liver fibrosis (which is damaged and scarred liver tissue).

If you are eligible and decide to take part in this research study, you will need to complete 1 or 2 screening visits to see if you are eligible to participate in the study. Once the study doctor determines you can participate in the study, you will be asked to come back to the clinic 8 times (for the Month 0 [Day 1] Visit, the Month 1 Visit, the Month 3 Visit, and then every 3 months) for the first 18 months you are in the study and then 2 times per year (every 6 months) for each additional year you are in the study.

Age Range
18 and up