Trial Outcomes & Findings for Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients (NCT NCT02006836)

Results Overview

Glycemic index (GI) measurement was carried out after an overnight fast on 2 occasions in every subject, each test being separated from the next by a "washout" day.The first test day utilized 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of the Majia pomelos. Venous blood samples were collected and monitored during 3 hrs for both the healthy and T2DM individuals at 0, 30, 60, 90, 120, 150, and 180 min. Areas under the curves (AUC) of blood glucose concentrations were obtained. The 50 g of glucose was used as the reference (GI = 100) according to the literature. The AUC under the incremental glycemic-response curves for Majia were expressed as a percentage of the areas under the glucose curves for the same subject. The resulting values for all subjects were averaged to calculate the GI. GI measurement is only calculated in case-control period.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

59 participants

Primary outcome timeframe

3 days

Results posted on

2014-06-26

Participant Flow

Dates of the recruitment period : 2013.1-2013.12, and there are two periods of the study. Case-control period: month 1- month 6, self-control period: month 7-month 12. Study participants were recruited from Tongji Hospital and local poster advertisements

In diabetic group, patients had taken metformin or pioglitazone or only on life modification for at least 3 months. In diabetic 2 group, patients were hospitalized treated with insulin for at least 6 days.We matched each of the diabetic patients to a healthy control according to age, BMI, and gender in the case-control period.

Participant milestones

Participant milestones
Measure	Case-Control: Diabetic For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.	Case-Control: Healthy For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.	Self-Control: Diabetic 2 For self-control period. 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. On the 4th to 6th day, patients with a constant dose of insulin did not consume Majia pomelos after meals, and this intervention was defined as blank. On the 7th to 9th day, patients with the same dose of insulin consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
Case-control Period: Month 1- Month 6 STARTED	20	20	0
Case-control Period: Month 1- Month 6 COMPLETED	20	20	0
Case-control Period: Month 1- Month 6 NOT COMPLETED	0	0	0
Self-control Period: Month 7-month 12 STARTED	0	0	19
Self-control Period: Month 7-month 12 COMPLETED	0	0	19
Self-control Period: Month 7-month 12 NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diabetic n=20 Participants For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.	Healthy n=20 Participants For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.	Diabetic 2 n=19 Participants For self-control period. The scheme and dose of Continuous Subcutaneous Insulin Infusion (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.	Total n=59 Participants Total of all reporting groups
Age, Continuous	55.15 years STANDARD_DEVIATION 2.52 • n=5 Participants	54.30 years STANDARD_DEVIATION 2.42 • n=7 Participants	50.42 years STANDARD_DEVIATION 2.48 • n=5 Participants	53.34 years STANDARD_DEVIATION 1.43 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	36 Participants n=4 Participants
Region of Enrollment China	20 participants n=5 Participants	20 participants n=7 Participants	19 participants n=5 Participants	59 participants n=4 Participants
Body weight	69 kg STANDARD_DEVIATION 2.9 • n=5 Participants	66.24 kg STANDARD_DEVIATION 2.43 • n=7 Participants	68.59 kg STANDARD_DEVIATION 2.64 • n=5 Participants	67.93 kg STANDARD_DEVIATION 1.52 • n=4 Participants
BMI	25.51 kg/m2 STANDARD_DEVIATION 0.97 • n=5 Participants	24.49 kg/m2 STANDARD_DEVIATION 0.64 • n=7 Participants	24.76 kg/m2 STANDARD_DEVIATION 0.69 • n=5 Participants	24.92 kg/m2 STANDARD_DEVIATION 0.45 • n=4 Participants
Systolic blood pressure	129.8 mmHg STANDARD_DEVIATION 3.5 • n=5 Participants	124.65 mmHg STANDARD_DEVIATION 3.66 • n=7 Participants	128.32 mmHg STANDARD_DEVIATION 3.36 • n=5 Participants	127.58 mmHg STANDARD_DEVIATION 2.01 • n=4 Participants
Diastolic blood pressure	78.05 mmHg STANDARD_DEVIATION 2.11 • n=5 Participants	75.25 mmHg STANDARD_DEVIATION 1.96 • n=7 Participants	82.0 mmHg STANDARD_DEVIATION 1.74 • n=5 Participants	78.37 mmHg STANDARD_DEVIATION 1.16 • n=4 Participants
HbA1c	7.53 % STANDARD_DEVIATION 0.45 • n=5 Participants	5.57 % STANDARD_DEVIATION 0.06 • n=7 Participants	10.06 % STANDARD_DEVIATION 0.61 • n=5 Participants	7.60 % STANDARD_DEVIATION 0.33 • n=4 Participants

PRIMARY outcome

Timeframe: 3 days

Glycemic index (GI) measurement was carried out after an overnight fast on 2 occasions in every subject, each test being separated from the next by a "washout" day.The first test day utilized 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of the Majia pomelos. Venous blood samples were collected and monitored during 3 hrs for both the healthy and T2DM individuals at 0, 30, 60, 90, 120, 150, and 180 min. Areas under the curves (AUC) of blood glucose concentrations were obtained. The 50 g of glucose was used as the reference (GI = 100) according to the literature. The AUC under the incremental glycemic-response curves for Majia were expressed as a percentage of the areas under the glucose curves for the same subject. The resulting values for all subjects were averaged to calculate the GI. GI measurement is only calculated in case-control period.

Outcome measures

Outcome measures
Measure	Diabetic 2 - With Pomelo n=20 Participants 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).	Diabetic 2 - Without Pomelo n=20 Participants 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.
Glycemic Index	86.92 percentage of AUC from GI100 Standard Deviation 2.17	76.79 percentage of AUC from GI100 Standard Deviation 1.83

PRIMARY outcome

Timeframe: 9 days

Population: The patients met the inclusion/exclusion criteria and completed the study.

After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after breakfast were obtained and analyzed. * g of breasfast without pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast. * g of breasfast with pomelo=mean of 3 days of postprandial blood glucose after breakfast - mean of 3 days of blood glucose before this breakfast.

Outcome measures

Outcome measures
Measure	Diabetic 2 - With Pomelo n=19 Participants 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).	Diabetic 2 - Without Pomelo n=19 Participants 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.
∆g of Breakfast With/Without Pomelo	3.61 mmol/l Standard Deviation 0.58	2.93 mmol/l Standard Deviation 0.72

PRIMARY outcome

Timeframe: 9 days

After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after lunch were obtained and analyzed. * g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch without pomelo - mean of 3 days of blood glucose before this lunch. * g of lunch with pomelo=mean of 3 days of postprandial blood glucose after lunch with pomelo- mean of 3 days of blood glucose before this lunch.

Outcome measures

Outcome measures
Measure	Diabetic 2 - With Pomelo n=19 Participants 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).	Diabetic 2 - Without Pomelo n=19 Participants 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.
∆g of Lunch With/Without Pomelo	2.87 mmol/l Standard Deviation 0.47	1.39 mmol/l Standard Deviation 0.63

PRIMARY outcome

Timeframe: 9 days

After the dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, there were 3-day CSII treatment without change of insulin dose. Capillary blood samples were detected before and after meals. Glucose difference (∆g) before and after dinner were obtained and analyzed. * g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner without pomelo - mean of 3 days of blood glucose before this dinner. * g of dinner with pomelo=mean of 3 days of postprandial blood glucose after dinner with pomelo - mean of 3 days of blood glucose before this dinner.

Outcome measures

Outcome measures
Measure	Diabetic 2 - With Pomelo n=19 Participants 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).	Diabetic 2 - Without Pomelo n=19 Participants 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.
∆g of Dinner With/Without Pomelo	1.41 mmol/l Standard Deviation 0.24	0.34 mmol/l Standard Deviation 0.41

PRIMARY outcome

Timeframe: 9 days

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. Capillary blood samples were detected before and after meals, 10pm, and 3am. Mean of each time point(before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner,10pm, and 3am ) of blood glucose concentrations on 4th to 6th day（without pomelo） were calculated and so as each time point of blood glucose concentrations on 7th to 9th day (with pomelo). Areas under the curves (AUC) of mean blood glucose concentrations of each time point were obtained with/without pomelo.

Outcome measures

Outcome measures
Measure	Diabetic 2 - With Pomelo n=19 Participants 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).	Diabetic 2 - Without Pomelo n=19 Participants 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.
AUCs With/Without Pomelo	163.07 mmol*hour/L Standard Deviation 6.90	164.04 mmol*hour/L Standard Deviation 7.58

Adverse Events

Diabetic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Healthy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetic 2 - Without Pomelo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diabetic 2 - With Pomelo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Yu

Huazhong University of Science and Technology

Phone: 862783662883

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place