Clinical trial NCT02006836
Conditions: Diabetes
Keywords: glycemic index glycemic response diabetes pomelo
Sponsor: Huazhong University of Science and Technology
Start date: 2013-01-01; Completion date: 2013-12-01
Enrollment: 59 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Food intake has a great influence on blood glucose of patients with diabetes. This study was designed to determine the glycemic index (GI) of a particular pomelo named Majia pomelo and its effects on postprandial glucose (PPG) excursions in both healthy subjects and patients with type 2 diabetes (T2DM).

Detailed description:
The purpose of this study was to evaluate the GI and effects on glucose excursion of Majia pomelo in both healthy and diabetic subjects. The results may help diabetic subjects and their health care providers in developing a diet that is both medically and culturally appropriate.

Arms: arm 1: Diabetic patients use metformin or only on diet control(met or diet).18 of the patients were on metformin treatment and 2 patients were on diet control due to the early stage of this disease. On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of diabetic patients enrolled for the case control period. arm 2: On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of volunteers enrolled for the case control period. arm 3: Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank. arm 4: Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
Interventions: intervention 1: Pomelo intervention 2: Glucose intervention 3: Blank intervention 4: Insulin intervention 5: met or diet
Intervention descriptions: intervention 1: The sugar content of the pomelo was 5.86% of full weight, and we use 922g Majia pomelos which contained about 50g sugar equal to 50g glucose for GI measurement. intervention 2: We dissolved 50 g of glucose in 200 ml water. intervention 3: For the self-control period the diabetic patients underwent 3-day CSII treatment without change of insulin dose and we did not applied any intervention. intervention 4: Patients who were included in the test of glycemic responses to postprandial pomelo consumption were hospitalized with the treatment of Continuous Subcutaneous Insulin Infusion(CSII), and the insulin for CSII was insulin aspart(NovoRapid). intervention 5: In diabetic group, 20 diabetic patients were included for GI measurement , 18 of whom were on metformin treatment. Only 2 patients were on diet control due to the early stage of this disease.

Protocol documents: