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Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
RECRUITINGN/ASponsored by University of Delaware
Actively Recruiting
PhaseN/A
SponsorUniversity of Delaware
Started2026-05
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07450118
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * 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) Exclusion Criteria: * 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)
Conditions2
DiabetesPreDiabetes
Locations1 site
Nutrition Clinic, University of Delaware
Newark, Delaware, 19713
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Actively Recruiting
PhaseN/A
SponsorUniversity of Delaware
Started2026-05
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT07450118