Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans

Recruiting now · Not applicable

Conditions studied: Prediabetes

In brief

This nested pilot Randomized Clinical Trial will determine whether the Diabetes Prevention Program (DPP) enhanced with evidence-based sleep health and time restricted eating interventions ("DPP++") is more effective than the DPP alone for improving metabolic and cardiovascular metrics in 40 overweight/obese adults with prediabetes.

Key facts

Study ID

NCT07450118

Run by

University of Delaware

People needed

40

Starts

2026-05-01

Expected to finish

2027-06-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18 years or older
• Prediabetes confirmed by blood test result within 12 months of enrollment, previous diagnosis of gestational diabetes mellitus (GDM), or positive screening for prediabetes based on the Prediabetes Risk Test
• BMI of 25 kg/m² or greater (23 kg/m² or greater for Asian Americans)

You may not qualify if…

• Age younger than 18 years
• BMI less than 25 kg/m² (less than 23 kg/m² for Asian Americans)
• No current diagnosis of prediabetes or gestational diabetes mellitus
• Prior diagnosis of type 1 or type 2 diabetes
• Pregnancy at the time of enrollment
• Development of a medical condition that, in the PI's judgment, could be exacerbated by the study interventions (e.g., eating disorder, severe sleep disorder)

Where it is running

• Nutrition Clinic, University of Delaware — Newark, Delaware, United States (enrolling)

Full record on ClinicalTrials.gov

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