PROMISE

Official Title
PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life (PROMISE)
Purpose

The purpose of this study is to find out more about how health and exposures during pregnancy, such as having an infection, diet and growth may impact later risk of islet autoimmunity in the
child. We are also interested in finding out more about why having a father or sibling with type 1 diabetes increases risk of autoimmunity in the child than having a mother with type 1 diabetes.

Could this study be right for you?

Inclusion:
Pregnant women:
- who is between 8-24 weeks gestation with a singleton pregnancy
- have had type 1 diabetes for at least 12 months, or the father of the baby or a full sibling of the baby has type 1 diabetes
- is 18 years of age or older
- is willing to have blood collected and to complete questionnaires about prenatal exposures once per trimester during their pregnancy (up to 3 visits) and up to 12
weeks after they deliver their baby
- is willing to have their baby screened for genetic risk for type 1 diabetes, to complete online questionnaires, and to have their child followed for measurement
of islet autoimmunity according to the determined risk for type 1 diabetes, through 5-7 years of age.
o If low risk, two screenings: the first at 2 years of age and the second between 5-7 years of age
o If high risk, five screenings: every six months through 2 years of age, and one between 5-7 years of age

The father of the baby will also be asked to complete one visit during pregnancy but it is not mandatory.

Exclusion:
- Multiple Gestation pregnancy
- Mother unable to consent due to intellectual impairment
- Fetus with known medical issue that would affect study participation
- Surrogate / gestational mothers who are not biologically related to offspring they are carrying

Age Range
18 years and up

Healthy Diet Study

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 heart failure and diabetes or pre-diabetes or metabolic syndrome.

 

Could this study be right for you?
  • 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 ≥50% 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

Understanding Patient Experiences of Gestational Diabetes

Official Title
A Multi-Actor Examination of Gestational Diabetes Mellitus (GDM)
Purpose

This study aims to examine the experience of people who have been diagnosed or are currently living with gestational diabetes, including how they manage and make sense of their diagnosis. 

Could this study be right for you?
  • Aged 18 years or older
  • Must live in the state of Ohio
  • Must be currently pregnant and have been diagnosed with gestational diabetes OR must have been diagnosed with gestational diabetes during a recent pregnancy (within the last 12 months)
Age Range
18 years and up

A Study for Participants with Type 2 Diabetes Mellitus and Atrial Fibrillation

Official Title
Effect of Glucose Fluctuations on Atrial Fibrillation Burden among Patients with Diabetes Mellitus and Paroxysmal Atrial Fibrillation or Recent Atrial Fibrillation Ablation
Purpose

The purpose of this study is to examine the effects of glucose levels on atrial fibrillation episodes in people with diabetes and history of atrial fibrillation.

The duration of the study lasts 6 months. 

Could this study be right for you?
  • Participants diagnosed with type 2 diabetes mellitus
  • Body mass index between 25 and 45 kg/m2
  • Insulin use at least 10 units per day or more than 1 glucose lowering medication with a hemoglobin A1c greater than 7%
  • ICM placement
  • Paroxysmal atrial fibrillation (irregular heartbeat that goes back to normal after a week) or atrial fibrillation ablation (procedure to treat irregular heartbeat) within 30 days
Age Range
40 - 79 years

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 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 Understand How Medications Can Affect Prediabetes in African Americans

Official Title
The Role of the Renin-Angiotensin-Aldosterone System in Adiposity, Blood Pressure and Glucose Metabolism among African Americans: Pilot Study
Purpose

The purpose of this study is to find out if taking one medication Diovan (valsartan) or a combination of two medications (valsartan and sacubatril) in one pill called Entresto, will improve prediabetes in Blacks /African Americans over the course of 6 months. We will also look for changes in blood pressure and blood vessel stiffness throughout the course of the study in order to better understand how these medications may impact prediabetes.

Could this study be right for you?

Inclusion Criteria: - African American aged 18-65 years old - History of impaired fasting glucose - Impaired glucose tolerance - A1c 5.7-6.4% or other risk factors for diabetes Exclusion Criteria: - Type 2 diabetes - Systolic blood pressure greater than 150/100 or medications to lower your blood pressure - Systolic blood pressure less than 100/60 - Steroid use - Hyperkalemia (high potassium levels)

Age Range
18 and up

A Study for those with Type 2 Diabetes AND Depression

Official Title
Mindfulness-based cognitive therapy for comorbid depression and type 2 diabetes
Purpose

The aim of this study is to improve mood and diabetes-related outcomes for those with type 2 diabetes mellitus (T2DM) AND symptoms of depression. The present study will examine the effect of mindfulness-based cognitive therapy (MBCT) on symptoms of depression and diabetes.

Your participation in this study will last 8 weeks.

Could this study be right for you?

You may qualify if:
• You are between the ages 18-75
• You have type 2 diabetes
• You are feeling symptoms of depression

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

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