Official Title A prospective randomized unblinded study of ketogenetic versus mixed diet on exercise tolerance in subjects with the metabolic phenotype of heart failure with preserved ejection fraction

Purpose

The purpose of this study is to compare the effects of a well-formulated ketogenic diet with a low-fat diet on exercise tolerance in patients with diabetes or pre-diabetes or obesity; with shortness of breath or heart failure.

Could this study be right for you?

Inclusions:

• Age ≥ 18 years old and ≤ 80 years old & willingness to be randomized to either diet.
• NYHA class I – III for at least 3 months.
• Ejection fraction ≥40% by biplane 2D, or 3D echo, or CMR.
• Echo findings of abnormal or indeterminant diastolic function or RHC data: At rest: mean pulmonary capillary wedge pressure (PCWP) > 15 mmHg. Pulmonary vascular resistance (PVR) < 3 Wood Units.
• Stable medical therapy for at least 3 months as determined by the treating physician (no new cardiac or diabetic medications within 3 months of enrollment or during enrollment and dosage should be stable for 1 month prior to enrollment).
• Dose of oral diuretics changes allowed but must be stable for 1 week prior to randomization.
• Body Mass Index (BMI) ≥ 25 and ≤ 50 or Type 2 Diabetes Mellitus or prediabetes (fasting glucose of 100 - 125 mg/dL or hemoglobin A1C 5.7-6.4%) or metabolic syndrome.
• Ability to participate in exercise treadmill testing.
• Ability to sign written consent.

Exclusions:

• Women who are pregnant, current breast-feeding, or have intention to become pregnant while in the study.
• Known allergy or sensitivity to gadolinium-based contrast agents.
• Implanted pacemaker, cardioverter defibrillator, Cardiac resynchronization therapy, left ventricular assist devices.
• Other metallic implants/aneurysm clips that are contraindicated in MRI.
• Claustrophobia
• History of severe kidney disease of eGFR < 30 ml/kg/1.73m2.

Exclusion Criteria varies, please contact Study Coordinator.

Age Range

18 - 80 years

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

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

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

Official Title An Examination of the Diet Quality of Low-Income Children 6-24 months old

Purpose

The purpose of the research is to determine the dietary patterns and calculate the dietary quality of children 6 to 24 months of age and enrolled in childcare centers, WIC, and other places that serve parents of young children; and to identify the most important cultural, social, and economic factors influencing the dietary and feeding patterns of these children. The total amount of time you will be asked to volunteer for this study is 2 hours and 10 minutes.

Could this study be right for you?

• Parent or caregiver of a child 6 to 24 months old
• Receiving WIC, SNAP, or similar benefits
• Live in Franklin County, Ohio

Age Range

18 and up

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

*Calculate your BMI

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

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

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

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