Name (Synonyms) | Correlation | |
---|---|---|
drug1342 | Hypocaloric, low carbohydrate diet Wiki | 1.00 |
drug1343 | Hypocaloric, moderate low fat diet Wiki | 1.00 |
Name (Synonyms) | Correlation | |
---|---|---|
D003922 | Diabetes Mellitus, Type 1 NIH | 0.41 |
D050177 | Overweight NIH | 0.38 |
D003920 | Diabetes Mellitus, NIH | 0.24 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0100651 | Type I diabetes mellitus HPO | 0.41 |
HP:0000819 | Diabetes mellitus HPO | 0.24 |
There is one clinical trial.
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.
Description: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: Weight in kilograms will be obtained at measurement visits at the beginning and end of this three-and-a-half month time period.
Measure: Change in weight - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: 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.
Measure: Change in HbA1C - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: 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.
Measure: Change in HbA1C - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: 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.
Measure: Change in HbA1C - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: Change in the percent of time spent in hypoglycemia 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.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 1 Time: 2 weeks of wear from Baseline Visit (-14 Days), 2 weeks of wear from 3 Month (Measurement 2) VisitDescription: Change in the percent of time spent in hypoglycemia 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.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 2 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in the percent of time spent in hypoglycemia 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.
Measure: Difference in Percent Time Spent in Hypoglycemia - Randomization 3 Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this time three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 1 Time: Baseline (-14 Days prior to Randomization 1 Visit), 3 Month (Measurement 2) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 2 Time: 3 Month (Measurement 2) Visit, 6.5 Month (Measurement 3) VisitDescription: Percent fat mass and percent fat free mass will be measured via a dual-energy x-ray absorptiometry (DXA) scan at the beginning and end of this three-and-a-half-month time period. COVID-19 PROVISIONS: Due to precautions required to prevent the spread of COVID-19, all in-person visits were discontinued as of 3/25/2020. As of this date, DXA scans at both sites were discontinued. Analysis on existing data will continue, but no new DXA data will be collected.
Measure: Change in percent body fat - Randomization 3 Time: 6.5 Month (Measurement 3) Visit, 10 Month (Measurement 4) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) during 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 CGM insertion at Measurement Visit 2.
Measure: Difference in time spent within target blood glucose range - Randomization 1 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) 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.
Measure: Difference in time spent within target blood glucose range - Randomization 2 Time: 2 weeks of wear from 3 Month (Measurement 2) Visit, 2 weeks of wear from 6.5 Month (Measurement 3) VisitDescription: Change in percent of time spent in a pre-defined range of relative euglycemia (for a person with Type 1 diabetes) 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.
Measure: Difference in time spent within target blood glucose range - Randomization 3 Time: 2 weeks of wear from 6.5 Month (Measurement 3) Visit, 2 weeks of wear from 10 Month (Measurement 4) Visit