Trial Outcomes & Findings for Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients (NCT NCT02006836)
NCT ID: NCT02006836
Last Updated: 2014-06-26
Results Overview
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.
COMPLETED
NA
59 participants
9 days
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
| 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
| 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=99 Participants
|
54.30 years
STANDARD_DEVIATION 2.42 • n=107 Participants
|
50.42 years
STANDARD_DEVIATION 2.48 • n=206 Participants
|
53.34 years
STANDARD_DEVIATION 1.43 • n=7 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
36 Participants
n=7 Participants
|
|
Region of Enrollment
China
|
20 participants
n=99 Participants
|
20 participants
n=107 Participants
|
19 participants
n=206 Participants
|
59 participants
n=7 Participants
|
|
Body weight
|
69 kg
STANDARD_DEVIATION 2.9 • n=99 Participants
|
66.24 kg
STANDARD_DEVIATION 2.43 • n=107 Participants
|
68.59 kg
STANDARD_DEVIATION 2.64 • n=206 Participants
|
67.93 kg
STANDARD_DEVIATION 1.52 • n=7 Participants
|
|
BMI
|
25.51 kg/m2
STANDARD_DEVIATION 0.97 • n=99 Participants
|
24.49 kg/m2
STANDARD_DEVIATION 0.64 • n=107 Participants
|
24.76 kg/m2
STANDARD_DEVIATION 0.69 • n=206 Participants
|
24.92 kg/m2
STANDARD_DEVIATION 0.45 • n=7 Participants
|
|
Systolic blood pressure
|
129.8 mmHg
STANDARD_DEVIATION 3.5 • n=99 Participants
|
124.65 mmHg
STANDARD_DEVIATION 3.66 • n=107 Participants
|
128.32 mmHg
STANDARD_DEVIATION 3.36 • n=206 Participants
|
127.58 mmHg
STANDARD_DEVIATION 2.01 • n=7 Participants
|
|
Diastolic blood pressure
|
78.05 mmHg
STANDARD_DEVIATION 2.11 • n=99 Participants
|
75.25 mmHg
STANDARD_DEVIATION 1.96 • n=107 Participants
|
82.0 mmHg
STANDARD_DEVIATION 1.74 • n=206 Participants
|
78.37 mmHg
STANDARD_DEVIATION 1.16 • n=7 Participants
|
|
HbA1c
|
7.53 %
STANDARD_DEVIATION 0.45 • n=99 Participants
|
5.57 %
STANDARD_DEVIATION 0.06 • n=107 Participants
|
10.06 %
STANDARD_DEVIATION 0.61 • n=206 Participants
|
7.60 %
STANDARD_DEVIATION 0.33 • n=7 Participants
|
PRIMARY outcome
Timeframe: 3 daysGlycemic 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
| Measure |
Diabetic
n=20 Participants
For case-control period. 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. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
|---|---|---|
|
Glycemic Index
|
76.79 percentage of AUC from GI100
Standard Deviation 1.83
|
86.92 percentage of AUC from GI100
Standard Deviation 2.17
|
PRIMARY outcome
Timeframe: 9 daysPopulation: 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
| Measure |
Diabetic
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
Healthy
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
|---|---|---|
|
∆g of Breakfast With/Without Pomelo
|
2.93 mmol/l
Standard Deviation 0.72
|
3.61 mmol/l
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: 9 daysAfter 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
| Measure |
Diabetic
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
Healthy
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
|---|---|---|
|
∆g of Lunch With/Without Pomelo
|
1.39 mmol/l
Standard Deviation 0.63
|
2.87 mmol/l
Standard Deviation 0.47
|
PRIMARY outcome
Timeframe: 9 daysAfter 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
| Measure |
Diabetic
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
Healthy
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
|---|---|---|
|
∆g of Dinner With/Without Pomelo
|
0.34 mmol/l
Standard Deviation 0.41
|
1.41 mmol/l
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: 9 daysPatients 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
| Measure |
Diabetic
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
Healthy
n=19 Participants
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
|
|---|---|---|
|
AUCs With/Without Pomelo
|
164.04 mmol*hour/L
Standard Deviation 7.58
|
163.07 mmol*hour/L
Standard Deviation 6.90
|
Adverse Events
Diabetic
Healthy
Diabetic 2 - Without Pomelo
Diabetic 2 - With Pomelo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place