BridgeMD
New treatment option for Type 2 Diabetes
Official title Extracellular Vesicles, Insulin Action, and Exercise
ClinicalTrials.gov ID: NCT06546085
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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%
See the full eligibility 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.
- 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...
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- New Brunswick, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Brunswick, New Jersey, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.