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Diabetes Prevention & Education for Prediabetes

N/A

Recruiting

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Qualify for DPP with a diagnosis of pre-diabetes and elevated BMI (≥25 kg/m2 , ≥23kg/m2 if Asian)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of calendar year enrollment, yearly for 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce risk of type 2 diabetes in people with pre-diabetes by increasing access to lifestyle interventions. We will also study changes in body fat & liver fat in those who complete the program.

Who is the study for?

This trial is for adults with prediabetes, obesity, or type 2 diabetes who want to prevent or manage their condition. Participants should have a BMI of at least 25 (or 23 if Asian) indicating overweight status. Those with normal blood sugar levels are not eligible.

What is being tested?

The trial tests the Diabetes Prevention Program (DPP) and Diabetes Self-Management Training (DSMT). It aims to see if these programs can reduce the risk of developing type 2 diabetes and improve body composition and liver health in participants.

What are the potential side effects?

As DPP and DSMT are educational programs focusing on lifestyle changes rather than medications, they typically do not have direct side effects like drugs do. However, changing diet and exercise might cause temporary discomfort.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am pre-diabetic with a BMI of 25 or higher, or 23 if I'm Asian.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of calendar year enrollment, yearly for 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of calendar year enrollment, yearly for 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of calendar year enrollment, yearly for 3 years 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 body weight for DPP participants

Enrollees into DPP and DSMT

Secondary study objectives

Change in diabetes control for DSMT participants

change in body composition in DPP participants

change in liver elastography in DPP participants

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: InterventionExperimental Treatment1 Intervention

All subjects participating in the diabetes prevention program will be offered body composition analysis and liver fat analysis, before, during, and after the lifestyle intervention

0 / 1Eligibility criteria met