RECRUITING

Extracellular Vesicles, Insulin Action, and Exercise

Talk to us

Conditions

Type 2 DiabetesObesity

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-02-10
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06546085

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female 30 - 80 years old.
  2. * HbA1c \<5.7% and fasting glucose \<100mg/dl to be considered NGT
  3. * T2D diagnosis or confirmation HbA1c ≥6.5% and fasting glucose ≥126 mg/dl
  4. * Prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors ≥1 year.
  5. * Has a body mass index of 20-25 or 28-45 kg/m2.
  6. * Not diagnosed with Type 1 diabetes.
  7. * Not currently engaged in \>150 min/wk of exercise.
  1. * Participants with morbid obesity (BMI \>45 kg/m2) and under-/overweight patients (BMI: ≤18 or 25-27.99 kg/m2).
  2. * Intolerance to insulin
  3. * Evidence of type 1 diabetes and diabetics requiring insulin therapy.
  4. * Participants who have not been weight stable (≥2 kg weight change in past 6 months)
  5. * Participants who have been recently active in past 6 months via health screening questions (≥150 min of moderate/high intensity exercise)
  6. * T2D with HbA1c ≥8.0%
  7. * Participants who are smokers or who have quit smoking ≤5 years ago
  8. * Participants prescribed metformin, GLP-1 agonists (oral/injectable), TZDs, DPP-IV inhibitors, Acarbose, SGLT-2 inhibitors within 1 year.
  9. * Hypertriglyceridemic (≥400 mg/dl) and hypercholesterolemic (≥260 mg/dl) participants as determined from LabCorp samples.
  10. * 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).
  11. * Hypertensive (≥160/100 mmHg) at time of screening.
  12. * Abnormal liver function (reflective from comprehensive panel liver enzymes Alk (≥121 IU/L), AST (≥40 IU/L) and ALT (≥32 IU/L) via LabCorp).
  13. * 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.
  14. * Pregnant (as evidenced by positive pregnancy test) or nursing women
  15. * Participants with contraindications to participation in an exercise training program
  16. * Known hypersensitivity to perflutren (contained in Definity).
  17. * Anemic as confirmed by hematocrit (HCT) (women ≤36%, Men ≤38%) at time of screening.
  18. * Suggested infections at time of screening as confirmed by WBC (≥10.8 x10E3/uL) and/or platelets (≥450 x10E3/uL).

Contacts and Locations

Study Contact

Steven K Malin, PhD
CONTACT
848-932-7540
steven.malin@rutgers.edu
Emily M Heiston, PhD
CONTACT
848-932-7540
emily.heiston@rutgers.edu

Principal Investigator

Steven K Malin, PhD
PRINCIPAL_INVESTIGATOR
Rutgers University - New Brunswick

Study Locations (Sites)

Institute for Food, Nutrition, and Health
New Brunswick, New Jersey, 08901
United States
Robert Wood Johnson University Hospital Clinical Research Center
New Brunswick, New Jersey, 08901
United States
Rutgers University Loree Gymnasium
New Brunswick, New Jersey, 08901
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Steven K Malin, PhD, PRINCIPAL_INVESTIGATOR, Rutgers University - New Brunswick

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-10
Study Completion Date2029-04

Study Record Updates

Study Start Date2025-02-10
Study Completion Date2029-04

Terms related to this study

Additional Relevant MeSH Terms

  • Type 2 Diabetes
  • Obesity