What side effects are associated with this type of intervention?

Common treatments for obesity include lifestyle modifications, pharmacotherapy, and surgical interventions. Lifestyle changes such as diet and exercise are generally safe but may lead to temporary discomfort or injury if not done properly. Pharmacotherapy, including drugs like metformin and GLP-1 receptor agonists, can cause gastrointestinal issues (nausea, diarrhea), hypoglycemia, and, in rare cases, more severe effects like lactic acidosis (metformin) or pancreatitis (GLP-1 agonists). Surgical interventions, such as bariatric surgery, carry risks of infection, nutrient deficiencies, and complications related to anesthesia. Each treatment has its own risk profile, and patients should discuss these with their healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for obesity that influence metabolic pathways include GLP-1 analogs like liraglutide and semaglutide. These drugs mimic the action of the glucagon-like peptide-1 hormone, which helps regulate appetite and food intake, thereby promoting weight loss. Liraglutide (Saxenda) was approved for chronic weight management in 2014, and semaglutide (Wegovy) received approval in 2021. Both drugs have shown efficacy in reducing body weight and improving metabolic health, making them relevant to the study of metabolic influences similar to those being investigated with small extracellular vesicles (sEVs).

What other types of research exist?

Promising novel alternatives to Small Extracellular Vesicles (sEVs) for obesity treatment in 2024 include Glucagon-Like Peptide-1 (GLP-1) receptor agonists such as semaglutide and liraglutide. These medications have demonstrated significant efficacy in weight reduction and improving metabolic parameters in patients with obesity. Additionally, Sodium-Glucose Cotransporter-2 (SGLT-2) inhibitors, which have shown benefits in weight management and cardiovascular outcomes, may also be considered.

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Behavioral Intervention

Low Calorie Diet for Obesity (SEV Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for obesity include dietary interventions, pharmacological treatments, and lifestyle changes. Dietary interventions, such as low-carbohydrate or Mediterranean diets, aim to reduce caloric intake and improve metabolic health. Pharmacological treatments, like GLP-1 analogs (e.g., liraglutide, semaglutide), work by enhancing insulin sensitivity, reducing appetite, and promoting weight loss. These treatments are crucial for obesity patients as they target metabolic pathways, helping to manage weight and reduce the risk of obesity-related conditions like type 2 diabetes and cardiovascular disease. Understanding these mechanisms can guide personalized treatment plans and improve patient outcomes.

N/A

Recruiting

Led By Dmitri Samovski, PhD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after 10% weight loss (~4-5 months) in people with metabolically abnormal obesity

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand why some people with obesity develop conditions like type 2 diabetes while others do not. Researchers will study tiny particles called small extracellular vesicles (sEVs) from different groups of people to see how they affect insulin use in cells and mice. The findings could lead to new treatments for obesity-related health issues.

Who is the study for?

This trial is for adults with obesity and signs of insulin resistance, such as high blood sugar or HbA1c levels. Participants should have a BMI between 30.0-50.0 kg/m2 if they're obese, or 18.5-24.9 kg/m2 if lean and healthy. They shouldn't have diabetes, liver diseases other than NAFLD, engage in regular exercise, drink excessively, take interfering medications, or be pregnant/lactating.

What is being tested?

The study aims to understand why some obese individuals don't develop type 2 diabetes or heart disease while others do. It involves examining the effects of small extracellular vesicles from humans on metabolic functions in cells and mice and includes a low-calorie diet intervention for those with unhealthy obesity.

What are the potential side effects?

While specific side effects are not detailed here since it's more observational regarding sEVs' impact on metabolism; however, potential side effects may arise from dietary changes which can include fatigue, hunger pangs, nutrient deficiencies if not monitored properly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is either between 18.5-24.9 or 30.0-50.0.

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My blood sugar and insulin resistance levels are within healthy ranges.

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I am obese with high insulin resistance or blood sugar levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after 10% weight loss (~4-5 months) in people with metabolically abnormal obesity

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after 10% weight loss (~4-5 months) in people with metabolically abnormal obesity

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after 10% weight loss (~4-5 months) in people with metabolically abnormal obesity for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the effect of exosomes on insulin sensitivity

Effect of exosomes on insulin sensitivity in cultured cells

Secondary study objectives

Abdominal adipose tissue volumes

Change in abdominal adipose tissue volumes

Change in fat mass and fat free mass

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: People with Metabolically Unhealthy Obesity - Low Calorie DietExperimental Treatment1 Intervention

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.

Group II: Metabolically healthy lean - Baseline testing onlyActive Control1 Intervention

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.

Group III: People with Metabolically Healthy Obesity - Baseline testing onlyActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include dietary interventions, pharmacological treatments, and lifestyle changes. Dietary interventions, such as low-carbohydrate or Mediterranean diets, aim to reduce caloric intake and improve metabolic health. Pharmacological treatments, like GLP-1 analogs (e.g., liraglutide, semaglutide), work by enhancing insulin sensitivity, reducing appetite, and promoting weight loss. These treatments are crucial for obesity patients as they target metabolic pathways, helping to manage weight and reduce the risk of obesity-related conditions like type 2 diabetes and cardiovascular disease. Understanding these mechanisms can guide personalized treatment plans and improve patient outcomes.

Dermatopontin, A Novel Adipokine Promoting Adipose Tissue Extracellular Matrix Remodelling and Inflammation in Obesity.A role for leukocyte integrins and extracellular matrix remodeling of adipose tissue in the risk of weight regain after weight loss.