Obesity Clinical Trial
— SEVOfficial title:
Effect of Small Extracellular Vesicles From Adipose Tissue on Insulin Action
NCT number | NCT05933707 |
Other study ID # | 202005117 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 14, 2023 |
Est. completion date | December 2028 |
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.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | December 2028 |
Est. primary completion date | October 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 25 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - History of diabetes, liver disease other than NAFLD or other serious diseases, - Consume excessive amounts of alcohol (>21 units/week for men and >14 units/week for women), - Take medications that could affect the study outcome measures, engage in regular exercise (>120 min/week), - Are pregnant or lactating |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of exosomes on insulin sensitivity in cultured cells | Exosomes obtained from the plasma and adipose tissue of metabolically healthy lean participants, and participants with metabolically healthy or metabolically unhealthy obesity will be tested in cultured cells and mice to determine their effect on insulin sensitivity. | Baseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity). | |
Primary | Change in the effect of exosomes on insulin sensitivity | Exosomes obtained from the plasma and adipose tissue of participants with metabolically unhealthy obesity before and after 10% weight loss will be tested in cultured cells and mice to determine their effect on insulin sensitivity. | Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity | |
Secondary | Differences in the content of microRNAs within exosomes obtained from plasma and adipose tissue | Exosomes obtained from the plasma and adipose tissue of metabolically healthy lean participants, and participants with metabolically healthy or metabolically unhealthy obesity will be analyzed to determine their microRNA composition. | Baseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity). | |
Secondary | Differences in the content of lipids within exosomes obtained from plasma and adipose tissue | Exosomes obtained from the plasma and adipose tissue of metabolically healthy lean participants, and participants with metabolically healthy or metabolically unhealthy obesity will be analyzed to determine their lipid composition. | Baseline only (cross-sectional comparison of metabolically healthy lean, and of people with metabolically healthy or metabolically unhealthy obesity). | |
Secondary | Changes in the content of microRNAs within exosomes obtained from plasma and adipose tissue | Exosomes obtained from the plasma and adipose tissue of metabolically unhealthy obesity before and after weight loss will be analyzed to determine changes in their microRNA content after weight loss. | Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity | |
Secondary | Changes in the content of lipids within exosomes obtained from plasma and adipose tissue | Exosomes obtained from the plasma and adipose tissue of metabolically unhealthy obesity before and after weight loss will be analyzed to determine changes in their lipid content after weight loss. | Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity | |
Secondary | Insulin sensitivity | Whole-body insulin sensitivity will be assessed by using the hyperinsulinemic-euglycemic clamp procedure | Baseline only (cross-sectional comparison of metabolically healthy lean, and people with metabolically healthy or metabolically unhealthy obesity). | |
Secondary | Change in insulin sensitivity | Whole-body insulin sensitivity will be assessed by using the hyperinsulinemic-euglycemic clamp procedure | Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity | |
Secondary | Fat mass and fat free mass | Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA) | Baseline only (cross-sectional comparison of metabolically healthy lean, and people with metabolically healthy or metabolically unhealthy obesity). | |
Secondary | Change in fat mass and fat free mass | Fat mass and fat free mass will be assessed using dual-energy x-ray absorptiometry (DXA) | Before and after 10% weight loss (~4-5 months) in people with metabolically abnormal obesity | |
Secondary | Abdominal adipose tissue volumes | Abdominal subcutaneous and intra-abdominal adipose tissue volumes will be assessed by magnetic resonance imagining (MRI) | Baseline only (cross-sectional comparison of metabolically healthy lean, and people with metabolically healthy or metabolically unhealthy obesity). | |
Secondary | Change in abdominal adipose tissue volumes | Abdominal subcutaneous and intra-abdominal adipose tissue volumes will be assessed by magnetic resonance imagining (MRI) | Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity | |
Secondary | Intra-hepatic triglyceride content | Intra-hepatic triglyceride content will be assessed by magnetic resonance techniques | Baseline only (cross-sectional comparison of metabolically healthy lean, and people with metabolically healthy or metabolically unhealthy obesity). | |
Secondary | Change in intra-hepatic triglyceride content | Intra-hepatic triglyceride content will be assessed by magnetic resonance techniques | Before and after ~10% weight loss (~4-5 months) in people with metabolically abnormal obesity |
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