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Exercise may unlock key to heart health in diabetes

NCT ID NCT06546085

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how tiny particles called extracellular vesicles affect blood flow in people with type 2 diabetes. Researchers will test whether 16 weeks of supervised treadmill exercise can change these particles and improve vascular function. The goal is to understand how exercise might help prevent heart disease in diabetes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
supervised treadmill exercise
What this could lead to
If successful, this could help design personalized exercise programs to prevent heart disease in people with type 2 diabetes.
What could go wrong
This is an early-stage observational study with only 60 participants, so results may not apply to everyone. It looks at biological markers, not direct health outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Institute for Food, Nutrition, and Health

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Robert Wood Johnson University Hospital Clinical Research Center

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Rutgers University Loree Gymnasium

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

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