Official Title Concurrent optical and magnetic stimulation (COMS) for treatment of refractory diabetic foot ulcer; a prospective randomized, sham-controlled, double-blinded, pivotal clinical trial

Purpose

The purpose of this study is to evaluate the safety and effectiveness of the treatment with the COMS One device in subjects with refractory diabetic foot ulcers (DFUs). 

The duration of this study will last up to 28 weeks. 

Could this study be right for you?

Inclusion

• Male and females aged 22 to 90 years old 
• Able to understand and sign the informed consent form (ICF) and comply with requirements set in the protocol including trial visits, trial treatment and dressing regimens and compliance with required offloading device (if applicable)
• Type 1 or Type 2 diabetes mellitus

Exclusion

• Known pregnancy or lactating
• Active skin cancer, a history of skin cancer or any other localized cancer, precancerous lesions or large moles in the areas to be treated
   

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

Age Range

22 - 90 years

Official Title Essential Fats For Enhancing Cognitive Thinking (EFFECT) Study: Dietary Fat Quality and Cognitive Impairment

Purpose

The purpose of the EFFECT Study is to determine how dietary fats influence cognitive (mental) function in adults.

 

During the 7-week study participants will

• Consume one study food per day for a total of 3 weeks
• Have their blood drawn
• Have their body weight and shape measured
• Complete cognitive tests
• Fill out questionnaires
• Complete diet and physical activity recalls

Could this study be right for you?

• Feel your memory or concentration is not as good as you'd like it to be
• Are overweight
• Do NOT have diabetes
• Do NOT have dementia or Alzheimer's
• Do NOT have food allergies 
• Are NOT pregnant or nursing an infant

Age Range

40 - 75 years

Official Title Strategies to Augment Ketosis- Variations in Ketone Metabolism

Purpose

This study is being done to see how individuals respond to a ketone ester (KE) across different age groups and health statuses. With the ketogenic diet becoming more popular, research on ketones (a molecule created when fat is broken down in the body) has grown as well. 

These findings will be used to help develop future research studies and help others to pick the right doses of ketone supplement.

Could this study be right for you?

• Do NOT smoke or have diabetes, liver disease, kidney disease, cardiovascular disease, or any form of endocrine dysfunction
• Have NOT experienced >10% weight loss in the last 6 months
• Do NOT currently consume a low carbohydrate diet
• Do NOT consume alcohol more than 3 drinks/daily or 14 drinks/weekly
• Do NOT suffer from food allergies or gastrointestinal disorders

Age Range

20 - 70 years

Official Title Strategies to Augment Ketosis: Ketone Conferred Resiliency Against Sleep Restriction (STAK-Sleep)

Purpose

To examine if drinking a ketone supplement, twice a day, can improve brain, digital shooting, and physical performance during short-term sleep restriction (4 nights, 50% of normal sleep).

Could this study be right for you?

• Healthy
• Age: 18 - 40 years old
• BMI: 20-35 kg/m2
• No diagnosed sleep disorders
• Not consuming a ketogenic diet

Age Range

18 - 40 years

Official Title Strategies to Augment Ketosis: Optimization of Ketone Delivery Strategies (STAK: OK'd)

Purpose

This study is intended to evaluate the effects of different dosing measurements for different ketone products in healthy male adults. After giving consent to this study you will schedule 9 testing sessions about 3 days apart. During these sessions you will come into the Physical Activity and Education Services (PAES) building in the morning, having had no food that day and take a study product. Various tests will be administered after ingestion. You will have blood draws to tell us more about your metabolic response to the product.

Could this study be right for you?

• Have a BMI >18 kg/m2 or ≤29 kg/m2
• Do NOT smoke or have diabetes, liver disease, kidney disease, cardiovascular disease, or any form of endocrine dysfunction
• Do NOT currently consume a low carbohydrate diet

Age Range

20 - 30 years

Official Title Associations between Race, Gut Microbiota-Metabolites, and Long-Term Symptom Toxicity in African Americans and Caucasian Americans Colorectal Cancer Survivors

Purpose

The purpose of this study is to learn about the associations of symptoms such as fatigue, depression, and gastrointestinal distress including constipation, abdominal pain, and diarrhea with stool microbiomes and metabolites in patients with colorectal cancer. We will compare the associations of symptoms with microbiomes among colorectal cancer patients and healthy patients. You will be asked to complete several surveys that ask questions about your dietary habits, your health history, your social demographics, and your symptoms. You will also be asked to collect a stool sample with an at-home stool sample collection kit that will be provided to you.

Could this study be right for you?

• Diagnosed with stage I-IV colorectal cancer (ICD-10 C18, C19 and C20) OR Healthy.
• 18+ years of age at time of diagnosis.
• Able to communicate in English and provide consent.
• African American OR White.
• Not currently in cancer treatment.
• No current ostomy.
• No chronic bowel disorders (e.g., irritable bowel syndrome).
• No diagnosis of functional GI disorders.
• No food allergies or dietary restrictions.
• No use of probiotics or antibiotics within the past two months prior to fecal collection.
• No significant cognitive or developmental delay that precedes cancer diagnosis (e.g., down syndrome, autism spectrum disorder).

Age Range

18 years and up

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

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