RightFit
RecruitingNot applicable

Extracellular Vesicles, Insulin Action, and Exercise

Extracellular Vesicles, Insulin Action, and Exercise on Vascular Function in Type 2 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
30 Years to 80 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how tiny particles released by cells, called extracellular vesicles (EVs), affect insulin and blood vessels in type 2 diabetes. It also tests whether exercise changes how EVs affect blood flow and how the body uses food for energy. It is for adults ages 30–80 with normal blood sugar or type 2 diabetes.

Extracellular vesicles (EVs) play a role in obesity-induced insulin resistance and likely impact the development of cardiovascular disease. However, little is known on how EVs affect vascular insulin action in people. The purpose of this study is to understand how EVs play a role in type 2 diabetes related cardiovascular disease. This research will also study if exercise can change how EVs impact blood flow and metabolic health. This study will contribute to designing precision medicine to treat/prevent cardiovascular disease in type 2 diabetes.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 30–80.
  • Normal blood sugar: HbA1c below 5.7% and fasting blood sugar below 100 mg/dL. HbA1c measures average blood sugar over time.
  • Type 2 diabetes: a diagnosis, or HbA1c of at least 6.5% and fasting blood sugar of at least 126 mg/dL.
  • The listing requires at least 6 years of prescribed use of these diabetes medicines: metformin, GLP-1 drugs, TZDs, DPP-IV inhibitors, acarbose, or SGLT-2 inhibitors.
  • Body mass index (BMI), a measure of weight compared with height, from 20 to 45.
  • No type 1 diabetes.
  • Not currently exercising more than 150 minutes per week.

Who can't join

  • BMI above 45 or 18 or lower; weight change of at least 2 kg (about 4.4 pounds) in the past 6 months; or recent moderate or hard exercise of at least 150 minutes, as checked during screening.
  • Cannot tolerate insulin, have type 1 diabetes, need insulin treatment, or have type 2 diabetes with HbA1c of 10% or higher.
  • Smoke now or quit within the past 2 years; or were prescribed any of the listed diabetes medicines within the past 6 years.
  • High blood fats: triglycerides of at least 400 mg/dL or cholesterol of at least 260 mg/dL; or blood pressure of at least 160/100 at screening.
  • Kidney or liver test results outside the study's limits; or a major illness or cancer that the study doctor thinks could affect safety or results.
  • Pregnant, breastfeeding, or unable to safely take part in exercise training.
  • Known allergy to perflutren, an ingredient in Definity.
  • Anemia (too few red blood cells), or high white blood cell or platelet counts that suggest an infection at screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Male or female 30 - 80 years old. * HbA1c \<5.7% and fasting glucose \<100mg/dl to be considered NGT * T2D diagnosis or confirmation HbA1c ≥6.5% and fasting glucose ≥126 mg/dl * Prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors ≥6 year. * Has a body mass index of 20-24.99 or 25.0-45 kg/m2. * Not diagnosed with Type 1 diabetes. * Not currently engaged in \>150 min/wk of exercise. Exclusion Criteria: * Participants with morbid obesity (BMI \>45 kg/m2) and underweight patients (BMI: ≤18 kg/m2). * Intolerance to insulin * Evidence of type 1 diabetes and diabetics requiring insulin therapy. * Participants who have not been weight stable (≥2 kg weight change in past 6 months) * Participants who have been recently active in past 6 months via health screening questions (≥150 min of moderate/high intensity exercise) * T2D with HbA1c ≥10.0% * Participants who are smokers or who have quit smoking ≤2 years ago * Participants prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors within 6 year. * Hypertriglyceridemic (≥400 mg/dl) and hypercholesterolemic (≥260 mg/dl) participants as determined from LabCorp samples. * Kidney dysfunction as determined from LabCorp biochemical outcomes (e.g. creatinine (≥1.0 mg/dl), eGFR (≤59 ml/min/1.73), BUN (≥24 mg/dl) as derived from comprehensive metabolic panels). * Hypertensive (≥160/100 mmHg) at time of screening. * Abnormal liver function (reflective from comprehensive panel liver enzymes Alk (≥121 IU/L), AST (≥40 IU/L) and ALT (≥32 IU/L) via LabCorp). * History of significant metabolic, cardiac, cerebrovascular, hematological, pulmonary, gastrointestinal, liver, renal, or endocrine disease or cancer that in the investigator's opinion would interfere with or alter the outcome measures, or impact subject safety. * Pregnant (as evidenced by positive pregnancy test) or nursing women * Participants with contraindications to participation in an exercise training program * Known hypersensitivity to perflutren (contained in Definity). * Anemic as confirmed by hematocrit (HCT) (women ≤36%, Men ≤38%) at time of screening. * Suggested infections at time of screening as confirmed by WBC (≥10.8 x10E3/uL) and/or platelets (≥450 x10E3/uL).

Study sites (3)

NJ