Accelerating Solutions to Optimize Glycemic Control and Weight Management In Young Adults With Type 1 Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Change in Weight - Randomization 2
Study Overview
Brief Summary
An initial pilot and feasibility study will be conducted using a Sequential, Multiple Assignment, Randomized Trial (SMART) design to identify acceptable and effective dietary strategies to optimize both glycemic control and weight management in young adults with Type 1 diabetes (T1D). This pilot trial will include a ten-and-a-half month behavioral intervention, with co-primary outcomes of glycemic control (HbA1C and hypoglycemia) and weight loss. The pilot trial will assess acceptability and adherence to three distinct, evidence-based dietary approaches designed to address weight management and glycemic control. Behavioral counseling strategies, use of carbohydrate counting for insulin dosing, and encouragement of physical activity will be the same across the three dietary approaches.
COVID-19 PROVISIONS: Due to restrictions in place on in-person visits due to COVID-19 precautions, some subjects may remain in the study longer than 10.5 months. As of June 2020, the study transitioned to a completely virtual format. Those who were due for a measurement visit during the time that research activities were halted, prior to the approval of the virtual procedures, remained on the diet they were currently assigned to, supported by bi-weekly Registered Dietitian (RD) counseling, until they were able to be scheduled for a virtual visit.
Detailed Description
Eight-four participants will be randomized in total; 42 at the University of North Carolina (UNC), 42 at Stanford.
COVID-19 Provisions: Due to impacts of COVID-19, the study was forced to cease recruitment early. 40 subjects were randomized at UNC and 29 were randomized at Stanford, for a total of 69 subjects across sites.
Procedures (methods):
Three distinct dietary approaches will be tested. Dietary approaches are as follows:
Diet 1: hypocaloric, moderate low fat (30% calories from fat) weight management based on the Look AHEAD study Diet 2: hypocaloric, low carbohydrate (15-20% calories from carbohydrate, 59-63% as total fat (<10% saturated fat, at least 37% monounsaturated fat, remaining as polyunsaturated fat) Diet 3: advice to select a healthy Mediterranean dietary pattern with no caloric restriction
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 30 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Hypocaloric, low carbohydrate
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.
Intervention: Hypocaloric, low carbohydrate diet (Behavioral)
Hypocaloric, moderate low fat
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.
Intervention: Hypocaloric, moderate low fat diet (Behavioral)
Mediterranean, no caloric restriction
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.
Intervention: Mediterranean diet, no caloric restriction (Behavioral)
Outcomes
Primary Outcomes
Change in Weight - Randomization 2
Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit
Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Change in Weight - Randomization 3
Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit
Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Change in HbA1C - Randomization 1
Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit
HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Change in HbA1C - Randomization 3
Time Frame: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit
HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Change in Time in Clinical Hypoglycemia - Randomization 2
Time Frame: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit
Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 2 Visit and from CGM insertion at Measurement 3 Visit.
Change in Weight - Randomization 1
Time Frame: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit
Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Change in Time in Clinical Hypoglycemia - Randomization 1
Time Frame: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) Visit
Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during Continuous Glucose Monitor (CGM) wear time will be assessed between the two weeks of wear from CGM insertion at Baseline Visit (-14 days) and the two weeks of wear from the insertion of the CGM at Measurement Visit 2.
Change in HbA1C - Randomization 2
Time Frame: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit
HbA1c will be measured from a blood sample collected from participants. Blood will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Change in Time in Clinical Hypoglycemia - Randomization 3
Time Frame: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit
Change in the percent of time spent in clinical hypoglycemia (54-69 mg/dl) during CGM wear time will be assessed between the two weeks of wear from CGM insertion at Measurement 3 Visit and from CGM insertion at Measurement 4 Visit.
Secondary Outcomes
- Change in Time in Target Glucose Range - Randomization 1(2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit)
- Change in Body Fat - Randomization 1(Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) Visit)
- Change in Body Fat - Randomization 2(3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) Visit)
- Change in Time in Target Glucose Range - Randomization 2(2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) Visit)
- Change in Time in Target Glucose Range - Randomization 3(2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit)
- Change in Body Fat - Randomization 3(6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) Visit)