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Enzyme Preparation
ADI-PEG20 for Prediabetes
Phase 2
Waitlist Available
Led By Samuel Klein, MD
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
Prediabetes, defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7%, or HOMA-IR ≥2.5
Age: ≥18 and ≤22 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 8 weeks of adi-peg20 or placebo
Awards & highlights
Study Summary
This trial will look at how a new enzyme preparation affects insulin, energy usage & breath in teens with prediabetes.
Who is the study for?
This trial is for young adults aged 18 to 22 with a BMI between 25.0 and 44.9 who have prediabetes, indicated by specific blood sugar levels or insulin resistance markers. It's not open to those on certain meds or supplements, with serious health issues, allergies to the study drugs, metallic implants affecting MRI scans, or diabetes (HbA1C ≥6.5%).Check my eligibility
What is being tested?
The study tests if ADI-PEG20 improves how the body uses insulin and energy in adolescents with prediabetes compared to a placebo (a substance with no therapeutic effect). Participants will be randomly assigned to receive either ADI-PEG20 or placebo.See study design
What are the potential side effects?
Possible side effects of ADI-PEG20 may include allergic reactions due to its ingredients and potential unknown risks since it's being tested for new uses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have prediabetes based on my blood sugar or HbA1C levels.
Select...
I am between 18 and 22 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 8 weeks of adi-peg20 or placebo
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 8 weeks of adi-peg20 or placebo
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in insulin sensitivity
Secondary outcome measures
Change in intrahepatic triglyceride content
Change in muscle mitochondrial respiration
Change in oral glucose tolerance
+2 moreOther outcome measures
Change in the transcriptome in adipose tissue
Change in the transcriptome in muscle
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ADI-PEG20Experimental Treatment1 Intervention
ADI-PEG20 (ADI-PEG20 is arginine deiminase (ADI) conjugated to polyethylene glycol (PEG) of 20,000 molecular weight) will be weekly intramuscularly at a dose of 18 mg/m2 body surface area/week for 8-week.
Group II: PlaceboPlacebo Group1 Intervention
Will be weekly intramuscularly for 8-week
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,661 Total Patients Enrolled
77 Trials studying Obesity
13,769 Patients Enrolled for Obesity
Polaris Pharmaceuticals, Inc.UNKNOWN
Children's Discovery InstituteOTHER
4 Previous Clinical Trials
427 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have prediabetes based on my blood sugar or HbA1C levels.Your HbA1C level is higher than 6.5%.You are allergic to the ingredients in ADI-PEG20 or the placebo.You have metal implants that would prevent you from having an MRI.I am not taking supplements or medications that could interfere with the study.Your body mass index (BMI) is between 25.0 and 44.9.I am between 18 and 22 years old.I have a major organ system that is not working properly.
Research Study Groups:
This trial has the following groups:- Group 1: ADI-PEG20
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Do I meet the requirements to participate in this research?
"Qualified candidates for this medical trial must suffer from obesity and be between the ages of 18 to 22. The total number of participants needed is 48."
Answered by AI
Are geriatric patients being included in the research for this clinical trial?
"As this clinical trial is specifically designed for young adults, only those aged 18 to 22 are allowed to participate. Moreover, there are 205 trials being conducted on minors and 777 studies targeting elderly patients."
Answered by AI
Has ADI-PEG20 been certified by the FDA?
"The safety of ADI-PEG20 has been assessed to a score of 2, as there is some evidence of its security but no proof yet that it will yield the desired effects."
Answered by AI
Are there any available openings to join this investigation?
"As indicated by information on clinicaltrials.gov, this trial is no longer accepting participants at the current time. It was initially posted June 1st 2023 and last updated April 24th 2023. However, 1183 other studies are actively looking for volunteers as of now."
Answered by AI
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