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Behavioral Intervention

Low Calorie Diet for Obesity (SEV Trial)

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

SEV Trial Summary

This trial seeks to understand why some people with obesity are protected from health risks while others are not, and to test the effect of tiny particles from human cells on metabolic health.

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.Check my eligibility
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.See study design
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.

SEV Trial 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.

SEV Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the effect of exosomes on insulin sensitivity
Effect of exosomes on insulin sensitivity in cultured cells
Secondary outcome measures
Abdominal adipose tissue volumes
Change in abdominal adipose tissue volumes
Change in fat mass and fat free mass
+9 more

SEV 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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,937 Previous Clinical Trials
2,299,623 Total Patients Enrolled
77 Trials studying Obesity
13,745 Patients Enrolled for Obesity
Dmitri Samovski, PhDPrincipal InvestigatorWashington University School of Medicine

Media Library

People with Metabolically Unhealthy Obesity (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05933707 — N/A
Obesity Research Study Groups: Metabolically healthy lean - Baseline testing only, People with Metabolically Healthy Obesity - Baseline testing only, People with Metabolically Unhealthy Obesity - Low Calorie Diet
Obesity Clinical Trial 2023: People with Metabolically Unhealthy Obesity Highlights & Side Effects. Trial Name: NCT05933707 — N/A
People with Metabolically Unhealthy Obesity (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05933707 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accommodate geriatric participants?

"This medical study is accepting participants between the ages of 25 and 55."

Answered by AI

Could I potentially take part in this research investigation?

"This clinical research requires 72 volunteers, between the ages of 25 and 55 years old with obesity."

Answered by AI

What are the primary intentions of this clinical experiment?

"The primary outcome of this trial and the time frame to measure it is a modification in insulin sensitivity due to exosomes. Secondary outcomes encompass disparity in lipid content among plasma and adipose tissue exosomes from metabolically healthy lean people, as well as those with metabolically healthy or unhealthy obesity; microRNA variation within pre- and post-weight loss exosomes amongst individuals with metabolically unhealthy obesity; and lastly, changes in lipid composition between pre-and post-weight loss exosome samples taken from participants who are suffering from an unhealthily obese state."

Answered by AI

Is enrollment for this research experiment currently being accepted?

"This investigation is actively searching for subjects, as reported on clinicaltrials.gov; the trial was initially promulgated on June 14th 2023 and its last update occurred two weeks later on June 27th."

Answered by AI

What is the target number of participants for this clinical trial?

"Affirmative, according to the clinicaltrials.gov database this study is currently enrolling participants. It was posted on June 14th 2023 and updated most recently on June 27th 2023. 72 patients are needed at 1 medical centre for the project."

Answered by AI

Who else is applying?

What site did they apply to?
Washington University School of Medicine
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I am obese and concerned about my future health.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Small Extracellular Vesicles and Insulin Action
2023. "Small Extracellular Vesicles and Insulin Action". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05933707.
~48 spots leftby Oct 2028
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