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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

Must not have

Taking dietary supplements or medications known to affect our study outcomes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 8 weeks of adi-peg20 or placebo

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%).

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.

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 below

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I have prediabetes based on my blood sugar or HbA1C levels.

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I am between 18 and 22 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking supplements or medications that could interfere with the study.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 8 weeks of adi-peg20 or placebo 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 insulin sensitivity

Secondary study objectives

Change in intrahepatic triglyceride content

Change in muscle mitochondrial respiration

Change in oral glucose tolerance

+2 more

Other study objectives

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

0 / 3Eligibility criteria met