Does the distribution of carbohydrates in meals effect blood sugar responses for adults with Type 2 Diabetes following a low carbohydrate diet?

Authors
Category Primary study
Registry of TrialsANZCTR
Year 2022
INTERVENTION: This randomised cross over control trial compares 3 three intervention arms and a habitual control. All interventions are 3‐days with a 4‐day washout period. Participants will wear an activity monitor continuously during the 3‐day interventions and a continuous glucose monitor (CGM) for the entire 4 week intervention period. Participants will record daily intake daily using a weighed food record during the 4 week period. LC15: Participants will consume a diet of 90g carbohydrate distributed in 15g doses across 6 meals. LC30: Participants will consume a diet of 90g carbohydrate distributed in 30g doses across 3 meals, with the other 3 meals as close to 0g carbohydrate as possible. LC90: Participants will consume a diet of 90g carbohydrate distributed in any pattern they choose across 6 meals. For all intervention days food items will remain constant, with only the distribution of the food items as a variable. Participants will be provided with daily meal plans tailored to their intake needs using the Mifflin equation along with the raw ingredients required to construct the simple meals and snacks. No outside meals or snacks will be consumed during each 3‐day duration, however water and unsweetened black coffee/tea etc (non caloric beverages) can be consumed as desired. For LC15 and LC30 participants will consume 3 meals and 3 snacks as prescribed in their meal plan. The timing of the meals will be at the participants discretion but matched between conditions and recorded as part of the weighed food record. For LC90, participants will eat the same foods as during LC15 and LC30, however these foods may be consumed in any pattern and prepared as desired. CONDITION: Metabolic and Endocrine ‐ Diabetes Type 2 Diabetes; ; Type 2 Diabetes PRIMARY OUTCOME: 24 h incremental area under the glucose curve, measured using a continuous glucose monitor (CGM).[During each 3 day intervention period] SECONDARY OUTCOME: Time > 10.0 mmol/L measured via CGM[continuously during each 3 day intervention periods and control] adherence to interventions from food pictures and weighed food record[Daily for the 4 week study duration] Fasting blood glucose measured via CGM[Continuously during each 3 day intervention periods and control] glycaemic variability (including SD, MAG) measured via easy GV software[continuously during each of the 3 day intervention periods and control] Mean 24‐h glucose measured via CGM[continuously during each 3 day intervention periods and control] nocturnal/overnight glucose measured via CGM[continuously during 3‐day interventions and control] Physical activity and sedentary time measured from activity monitor[continuously during 3‐day interventions and control] postprandial glucose measured from the 2‐h post‐meal via CGM[continuously during 3‐day interventions and control] Time in range (4‐10 mmol/L) measured via CGM[continuously during each 3 day intervention periods and control] INCLUSION CRITERIA: Aged between 18 and 80 years Formal diagnosis of type 2 diabetes Stable medication for previous 3 months
Epistemonikos ID: 222b8934419956b967b72fd4a391623a5033dffa
First added on: Aug 25, 2024