Diabetes
Conditions
Keywords
glycemic index, glycemic response, diabetes, pomelo
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.
Interventions
DIETARY_SUPPLEMENTPomelo
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.
DIETARY_SUPPLEMENTGlucose
We dissolved 50 g of glucose in 200 ml water.
OTHERBlank
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.
DRUGInsulin
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).
DRUGmet or diet
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.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* In the diabetic and diabetic 2 groups, it required that their diabetes was controlled (HbA1c ≤ 8%) on diet with or without metformin.
Exclusion criteria
* Morbid obesity (BMI \> 40 kg/m2) * Pre diabetes * Pregnancy * Presence of gastroenterological disorders * Alimentary tract surgery * A history of gastroenteritis in the prior six months * Any alcohol intake * Smoking * Taking any medications (except metformin) * Poorly controlled diabetes (HbA1c \> 8%) * Presence of chronic diseases (such as bronchial asthma or rheumatoid arthritis) or acute illness (such as upper respiratory tract or urinary tract infection)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Index | 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. |
| ∆g of Breakfast With/Without Pomelo | 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 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. |
| ∆g of Lunch With/Without Pomelo | 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. |
| ∆g of Dinner With/Without Pomelo | 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. |
| AUCs With/Without Pomelo | 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. |
Countries
China
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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. | 20 |
| Diabetic 2 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. | 19 |
| Total | 59 |
Baseline characteristics
| Characteristic | Diabetic | Healthy | Diabetic 2 | Total |
|---|---|---|---|---|
| Age, Continuous | 55.15 years STANDARD_DEVIATION 2.52 | 54.30 years STANDARD_DEVIATION 2.42 | 50.42 years STANDARD_DEVIATION 2.48 | 53.34 years STANDARD_DEVIATION 1.43 |
| BMI | 25.51 kg/m2 STANDARD_DEVIATION 0.97 | 24.49 kg/m2 STANDARD_DEVIATION 0.64 | 24.76 kg/m2 STANDARD_DEVIATION 0.69 | 24.92 kg/m2 STANDARD_DEVIATION 0.45 |
| Body weight | 69 kg STANDARD_DEVIATION 2.9 | 66.24 kg STANDARD_DEVIATION 2.43 | 68.59 kg STANDARD_DEVIATION 2.64 | 67.93 kg STANDARD_DEVIATION 1.52 |
| Diastolic blood pressure | 78.05 mmHg STANDARD_DEVIATION 2.11 | 75.25 mmHg STANDARD_DEVIATION 1.96 | 82.0 mmHg STANDARD_DEVIATION 1.74 | 78.37 mmHg STANDARD_DEVIATION 1.16 |
| HbA1c | 7.53 % STANDARD_DEVIATION 0.45 | 5.57 % STANDARD_DEVIATION 0.06 | 10.06 % STANDARD_DEVIATION 0.61 | 7.60 % STANDARD_DEVIATION 0.33 |
| Region of Enrollment China | 20 participants | 20 participants | 19 participants | 59 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 7 Participants | 23 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 12 Participants | 36 Participants |
| Systolic blood pressure | 129.8 mmHg STANDARD_DEVIATION 3.5 | 124.65 mmHg STANDARD_DEVIATION 3.66 | 128.32 mmHg STANDARD_DEVIATION 3.36 | 127.58 mmHg STANDARD_DEVIATION 2.01 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 19 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 19 | 0 / 19 |
Outcome results
Primary
AUCs With/Without Pomelo
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | AUCs With/Without Pomelo | 164.04 mmol*hour/L | Standard Deviation 7.58 |
| Healthy | AUCs With/Without Pomelo | 163.07 mmol*hour/L | Standard Deviation 6.9 |
Comparison: H0: AUCp-value: >0.05t-test, 1 sided
Primary
Glycemic Index
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | Glycemic Index | 76.79 percentage of AUC from GI100 | Standard Deviation 1.83 |
| Healthy | Glycemic Index | 86.92 percentage of AUC from GI100 | Standard Deviation 2.17 |
Comparison: 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%p-value: 0.005t-test, 1 sided
Primary
∆g of Breakfast With/Without Pomelo
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
Population: The patients met the inclusion/exclusion criteria and completed the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | ∆g of Breakfast With/Without Pomelo | 2.93 mmol/l | Standard Deviation 0.72 |
| Healthy | ∆g of Breakfast With/Without Pomelo | 3.61 mmol/l | Standard Deviation 0.58 |
Comparison: 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.p-value: >0.05t-test, 1 sided
Primary
∆g of Dinner With/Without Pomelo
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | ∆g of Dinner With/Without Pomelo | 0.34 mmol/l | Standard Deviation 0.41 |
| Healthy | ∆g of Dinner With/Without Pomelo | 1.41 mmol/l | Standard Deviation 0.24 |
Comparison: 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.p-value: >0.05t-test, 1 sided
Primary
∆g of Lunch With/Without Pomelo
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diabetic | ∆g of Lunch With/Without Pomelo | 1.39 mmol/l | Standard Deviation 0.63 |
| Healthy | ∆g of Lunch With/Without Pomelo | 2.87 mmol/l | Standard Deviation 0.47 |
Comparison: 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.p-value: >0.05t-test, 1 sided