RECRUITING

Small Extracellular Vesicles and Insulin Action

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Conditions

ObesityInsulin ResistanceMetabolically Healthy ObesityObesity, Metabolically BenignWeight LossExosomesExtracellular vesicles

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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

The goals of this research study are to: 1) understand why some people with obesity are protected from developing conditions such as type 2 diabetes and cardiovascular disease while others are more likely to develop obesity-related conditions; 2) assess the effect of small extracellular vesicles (sEVs also called exosomes), obtained from human participants, on metabolic function in cultured cells and in mice.

Official Title

Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action

Quick Facts

Study Start:2023-06-08
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05933707

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:25 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Metabolically healthy lean subjects must have a BMI ≥18.5 and ≤24.9 kg/m²; Subjects with obesity must have a BMI ≥30.0 and ≤50.0 kg/m²
  2. * Metabolically healthy lean and people with metabolically healthy obesity must have intrahepatic triglyceride (IHTG) content ≤5%; fasting plasma glucose concentration \<100 mg/dl, 2-hr oral glucose tolerance plasma glucose concentration \<140 mg/dl, hemoglobin A 1C (HbA1c) ≤5.6% and HOMA-IR \<2.5.
  3. * People with metabolically unhealthy obesity must have intrahepatic triglyceride (IHTG) content ≥5.6%; HOMA-IR ≥2.5, and HbA1c 5.7%-6.4%, or fasting plasma glucose concentration ≥100 mg/dl, or 2-hr oral glucose tolerance test (OGTT) plasma glucose concentration ≥140 mg/dl.
  1. * History of diabetes, liver disease other than NAFLD or other serious diseases,
  2. * Consume excessive amounts of alcohol (\>21 units/week for men and \>14 units/week for women),
  3. * Take medications that could affect the study outcome measures, engage in regular exercise (\>120 min/week),
  4. * Are pregnant or lactating

Contacts and Locations

Study Contact

Johanna Sonnenschein
CONTACT
3142731879
nutritionresearch@wustl.edu
Beth Henk
CONTACT
3143628250
bhenk@wustl.edu

Principal Investigator

Dmitri Samovski, PhD
PRINCIPAL_INVESTIGATOR
Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine
Saint Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

  • Dmitri Samovski, PhD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

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 Date2023-06-08
Study Completion Date2028-12

Study Record Updates

Study Start Date2023-06-08
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Obesity
  • Weight Loss
  • Exosomes
  • Extracellular vesicles

Additional Relevant MeSH Terms

  • Obesity
  • Insulin Resistance
  • Metabolically Healthy Obesity
  • Obesity, Metabolically Benign