Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle Modification

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Description

The study will randomize 200 adults diagnosed with T2D within the last 12 months. Participants will be randomized to individualized RC or RC paired with individualized post-nutrient glucose excursion minimization (GEM) (RC+GEM). A Randomized Control Trial (RCT) with 1:1 randomization will be used to assign participants to treatment groups. All participants will receive glycemic treatment management from their PCP. Participants will be assessed before treatments, and at both 4.5 months and 13.5 months later. Assessments Visits will include clinical (hemoglobin A1c, lipids, blood pressure, weight, risk of cardiovascular disease, medication evaluation), behavioral (physical activity, carbohydrate intake) and psychosocial (depression, empowerment, diabetes distress) outcomes. Throughout the 13.5 month study period, each participant’s diabetes-related expenditures will be tracked.

Details
Age

Adult

Eligibility

Key Inclusion Criteria • Type 2 diabetes for 12 months or less • Age 30-80 years • Hemoglobin A1c = ≥6.5-≤9% Key Exclusion Criteria • Medications that impede weight loss (e.g., prednisone) within the last 3 months • Conditions that preclude increasing physical activity (e.g. severe neuropathy cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke, or severe mental disease like manic depressive illness, severe depression, active substance abuse) • Conditions that prevent doing the self-directed GEM program, such as inability to read English as GEM is only available in English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression • Currently undergoing treatment for cancer • Currently pregnant or anticipating pregnancy in the next 14 months

Type of Study

Outcomes Research

Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Tamara Oser,  MD

Tamara Oser, MD

Study ID

Protocol Number: 23-1398

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