Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients

• ClinicalTrials.gov Identifier: NCT02006836
• Recruitment Status: Completed
• First Posted: December 10, 2013
• Results First Posted: June 26, 2014
• Last Update Posted: June 26, 2014
• Sponsor: Huazhong University of Science and Technology
• Information provided by (Responsible Party): Xuefeng Yu, Huazhong University of Science and Technology

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Diabetes
• Interventions: Dietary Supplement: Pomelo; Dietary Supplement: Glucose; Other: Blank; Drug: Insulin; Drug: met or diet
• Enrollment: 59

Participant Flow

Recruitment Details	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
Pre-assignment Details	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.

Arm/Group Title	Case-Control: Diabetic	Case-Control: Healthy	Self-Control: Diabetic 2
Arm/Group Description	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.	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.	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).
Period Title: Case-control Period: Month 1- Month 6
Started	20	20	0
Completed	20	20	0
Not Completed	0	0	0
Period Title: Self-control Period: Month 7-month 12
Started	0	0	19
Completed	0	0	19
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Diabetic	Healthy	Diabetic 2	Total
Arm/Group Description		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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		20	20	19	59
Baseline Analysis Population Description		We chose the petients who met the inclusion/exclusion criteria and completed the study for the final analysis.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	20 participants	20 participants	19 participants	59 participants
		55.15 (2.52)	54.30 (2.42)	50.42 (2.48)	53.34 (1.43)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	20 participants	20 participants	19 participants	59 participants
	Female	8 40.0%	8 40.0%	7 36.8%	23 39.0%
	Male	12 60.0%	12 60.0%	12 63.2%	36 61.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
China	Number Analyzed	20 participants	20 participants	19 participants	59 participants
		20	20	19	59
Body weight; Mean (Standard Deviation); Unit of measure: Kg
	Number Analyzed	20 participants	20 participants	19 participants	59 participants
		69 (2.9)	66.24 (2.43)	68.59 (2.64)	67.93 (1.52)
BMI; Mean (Standard Deviation); Unit of measure: Kg/m2
	Number Analyzed	20 participants	20 participants	19 participants	59 participants
		25.51 (0.97)	24.49 (0.64)	24.76 (0.69)	24.92 (0.45)
Systolic blood pressure; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	20 participants	20 participants	19 participants	59 participants
		129.8 (3.5)	124.65 (3.66)	128.32 (3.36)	127.58 (2.01)
Diastolic blood pressure; Mean (Standard Deviation); Unit of measure: mmHg
	Number Analyzed	20 participants	20 participants	19 participants	59 participants
		78.05 (2.11)	75.25 (1.96)	82.0 (1.74)	78.37 (1.16)
HbA1c; Mean (Standard Deviation); Unit of measure: %
	Number Analyzed	20 participants	20 participants	19 participants	59 participants
		7.53 (0.45)	5.57 (0.06)	10.06 (0.61)	7.60 (0.33)

Outcome Measures

1. Primary Outcome

Title	Glycemic Index
Description	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.
Time Frame	3 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic	Healthy
Arm/Group Description:	For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.	For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
Overall Number of Participants Analyzed	20	20
Mean (Standard Deviation); Unit of Measure: percentage of AUC from GI100
	76.79 (1.83)	86.92 (2.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic, Healthy
	Comments	H0: GI of pomelo for diabetic patients - GI of pomelo for healthy people = 0 H1: GI of pomelo for diabetic patients - GI of pomelo for healthy people > 0 α=5%
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

2. Primary Outcome

Title	∆g of Breakfast With/Without Pomelo
Description	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.
Time Frame	9 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	19	19
Mean (Standard Deviation); Unit of Measure: mmol/l
	2.93 (0.72)	3.61 (0.58)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic 2 - Without Pomelo, Diabetic 2 - With Pomelo
	Comments	H0：∆g after breakfast- ∆g before breakfast = 0 H1：∆g after breakfast- ∆g before breakfast > 0 α=5%; 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.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

3. Primary Outcome

Title	∆g of Lunch With/Without Pomelo
Description	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.
Time Frame	9 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	19	19
Mean (Standard Deviation); Unit of Measure: mmol/l
	1.39 (0.63)	2.87 (0.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic 2 - Without Pomelo, Diabetic 2 - With Pomelo
	Comments	H0：∆g after lunch - ∆g before lunch = 0 H1：∆g after lunch - ∆g before lunch > 0 α=5%; g of lunch without pomelo=mean of 3 days of postprandial blood glucose after lunch - 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 - mean of 3 days of blood glucose before this lunch.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

4. Primary Outcome

Title	∆g of Dinner With/Without Pomelo
Description	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.
Time Frame	9 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	19	19
Mean (Standard Deviation); Unit of Measure: mmol/l
	0.34 (0.41)	1.41 (0.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic 2 - Without Pomelo, Diabetic 2 - With Pomelo
	Comments	H0：∆g after dinner- ∆g before dinner = 0 H1：∆g after dinner- ∆g before dinner > 0 α=5%; g of dinner without pomelo=mean of 3 days of postprandial blood glucose after dinner - 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 - mean of 3 days of blood glucose before this dinner.
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

5. Primary Outcome

Title	AUCs With/Without Pomelo
Description	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.
Time Frame	9 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	19	19
Mean (Standard Deviation); Unit of Measure: mmol*hour/L
	164.04 (7.58)	163.07 (6.90)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Diabetic 2 - Without Pomelo, Diabetic 2 - With Pomelo
	Comments	H0: AUC
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	>0.05
	Comments	[Not Specified]
	Method	t-test, 1 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	3 days for Diabetic and Healthy group. 9 days for Diabetic 2 - without pomelo and Diabetic 2 - with pomelo group.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Diabetic	Healthy	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
Arm/Group Description	Diabetic patients use oral antidiabetic drugs(metformin or pioglitazone or both) or only life style modification. 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.	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.	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.	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).
All-Cause Mortality
	Diabetic	Healthy	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--	--/--	--/--
Serious Adverse Events
	Diabetic	Healthy	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)	0/19 (0.00%)	0/19 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Diabetic	Healthy	Diabetic 2 - Without Pomelo	Diabetic 2 - With Pomelo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/20 (0.00%)	0/20 (0.00%)	0/19 (0.00%)	0/19 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr.Yu
• Organization: Huazhong University of Science and Technology
• Phone: 862783662883
• EMail: xfyu188@163.com

• Responsible Party: Xuefeng Yu, Huazhong University of Science and Technology
• ClinicalTrials.gov Identifier: NCT02006836
• Other Study ID Numbers: Tongji201201
• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Results First Submitted: December 21, 2013
• Results First Posted: June 26, 2014
• Last Update Posted: June 26, 2014