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

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Description

The study is looking for 200 adults diagnosed with T2D within the last 12 months. CU will enroll 100 of those participants. Participants will be assigned to one of two groups. The first group will receive individualized routine care. The second group will receive individualized routine care paired with the glucose excursion minimization guide and program. All participants will receive standard glycemic treatment management from their primary care doctor.. There are three in-person visits for this study. Participants will receive some blood work at the beginning, and at both 4.5 months and 13.5 months later. Tests 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 symptoms will be tracked.

Duration of Participation: 13.5 months

Details
Age

30 to 80 years

Eligibility

Key Inclusion Criteria 1. Type 2 diabetes for 12 months or less 2. Age 30-80 years 3. Hemoglobin A1c = ≥6.5-≤9% Key Exclusion Criteria 1. Medications that impede weight loss (e.g., prednisone) within the last 3 months 2... 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) 3. 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 4. Currently undergoing treatment for cancer 5. Currently pregnant or anticipating pregnancy in the next 14 months

Compensation

300

Locations

Department Specific Free Standing Clinic
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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