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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic | Other | 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. |
|
| Healthy | Other | 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. |
|
| Diabetic 2 - without pomelo | Other | 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. |
|
| Diabetic 2 - with pomelo | Other |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomelo | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
| ∆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.
| 9 days |
| ∆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.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xuefeng Yu, PhD MD | Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Wuhan | Hubei | 430030 | China |
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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Case-control Period: Month 1- Month 6 |
| |||||||||||||
| Self-control Period: Month 7-month 12 |
|
We chose the petients who met the inclusion/exclusion criteria and completed the study for the final analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Healthy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percentage of AUC from GI100 | 3 days |
|
3 days for Diabetic and Healthy group. 9 days for Diabetic 2 - without pomelo and Diabetic 2 - with pomelo group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diabetic | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Yu | Huazhong University of Science and Technology | 862783662883 | xfyu188@163.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D007328 | Insulin |
| D061267 | Insulin Aspart |
| D019859 | Proto-Oncogene Proteins c-met |
| D004032 | Diet |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D011384 |
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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). |
|
|
| Glucose | Dietary Supplement | We dissolved 50 g of glucose in 200 ml water. |
|
|
| Blank | Other | 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. |
|
| Insulin | Drug | 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). |
|
|
| met or diet | Drug | 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. |
|
|
| 9 days |
| ∆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.
| 9 days |
| 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. | 9 days |
| NOT COMPLETED |
|
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.
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body weight | Mean | Standard Deviation | kg |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| HbA1c | Mean | Standard Deviation | % |
|
For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos. |
| OG001 | Healthy | For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos. |
|
|
|
| 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.
| The patients met the inclusion/exclusion criteria and completed the study. | Posted | Mean | Standard Deviation | mmol/l | 9 days |
|
|
|
|
| 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.
| Posted | Mean | Standard Deviation | mmol/l | 9 days |
|
|
|
|
| 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.
| Posted | Mean | Standard Deviation | mmol/l | 9 days |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmol*hour/L | 9 days |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Healthy | 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. | 0 | 20 | 0 | 20 |
| EG002 | Diabetic 2 - 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. 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. | 0 | 19 | 0 | 19 |
| EG003 | Diabetic 2 - With 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. 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). | 0 | 19 | 0 | 19 |
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| Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061266 | Insulin, Short-Acting |
| D020794 | Receptor Protein-Tyrosine Kinases |
| D011505 | Protein-Tyrosine Kinases |
| D011494 | Protein Kinases |
| D017853 | Phosphotransferases (Alcohol Group Acceptor) |
| D010770 | Phosphotransferases |
| D014166 | Transferases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D011506 | Proteins |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D017978 | Receptors, Growth Factor |
| D018000 | Receptors, Peptide |
| D011518 | Proto-Oncogene Proteins |
| D015513 | Oncogene Proteins |
| D009363 | Neoplasm Proteins |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |