Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 25
Maximum Age: 55
Healthy Volunteers: t
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• 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

• 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.

• 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.

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Kyle Timmons
nutritionresearch@wustl.edu
3142731879
Backup
Beth Henk
bhenk@wustl.edu
3143628250
Time Frame
Start Date: 2023-06-08
Estimated Completion Date: 2029-09-01
Participants
Target number of participants: 72
Treatments
No_intervention: Metabolically healthy lean - Baseline testing only
Metabolically healthy lean - Lean individuals that have good glucose (sugar) control (defined as normal fasting glucose, glucose tolerance and hemoglobin A1c), normal insulin sensitivity (defined as Homeostatic Model Assessment of Insulin Resistance \[HOMA-IR\] \<2.5) and normal intrahepatic triglyceride (fat) levels.~Dietary intervention - None.
No_intervention: People with Metabolically Healthy Obesity - Baseline testing only
People with Metabolically Healthy Obesity - Persons with obesity that have good glucose (sugar) control, normal insulin sensitivity and normal intrahepatic triglyceride (fat) levels.~Dietary intervention - None.
Experimental: People with Metabolically Unhealthy Obesity - Low Calorie Diet
People with Metabolically Unhealthy Obesity - Persons with obesity with plasma glucose and intrahepatic triglyceride (fat) levels higher than recommended in combination with insulin resistance (defined as HOMA-IR ≥2.5).~Dietary intervention - Low calorie diet.
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine

This content was sourced from clinicaltrials.gov