ACT1ON Phase 2 (SMART Pilot) and Phase 3 (Efficacy Trial Development) (ACT1ON DP3)
Diabetes Mellitus, Type 1, Overweight and Obesity
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 diabetes, T1D, Type 1 diabetes mellitus (T1DM), weight management, overweight, obese
Eligibility Criteria
Inclusion Criteria:
- Individuals 19-30 years old at enrollment
- History of Type 1 diabetes for greater than one year
- Latest hemoglobin A1c less than 13%
- BMI of 27-39
Exclusion Criteria:
- Individuals with other metabolic disorders, unstable thyroid disease, diagnosed eating disorder, prohibitive strict dietary restrictions or those with other serious condition that renders participation inappropriate
- Individuals who have experience diabetic ketoacidosis (DKA) or severe hypoglycemia requiring outside assistance in the last 6 months
- Females who are pregnant, breastfeeding, have delivered a baby in the last 12 months, or are planning to become pregnant during the study period.
- Individuals unwilling to follow any of the three study diets
- Individuals who monitor blood glucose less than 3 times a day
Sites / Locations
- Stanford University
- University of North Carolina at Chapel Hill
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Hypocaloric, low carbohydrate
Hypocaloric, moderate low fat
Mediterranean, no caloric restriction
Behavioral intervention to include lifestyle counseling on hypocaloric, low carbohydrate diet (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat). Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Behavioral intervention to include lifestyle counseling on hypocaloric, moderate low fat diet (30% calories from fat) weight management based on the Look AHEAD study. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.
Behavioral intervention to include lifestyle counseling on selecting a healthy Mediterranean diet, no caloric restriction. Using a priori decision rules at 3.5 and 7 months post-initial randomization, those for whom the diet assigned is not acceptable or is not effective will be re-randomized.