Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients
NCT ID: NCT02006836
Last Updated: 2014-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
59 participants
INTERVENTIONAL
2013-01-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Diabetic
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.
Pomelo
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.
Glucose
We dissolved 50 g of glucose in 200 ml water.
met 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.
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.
Pomelo
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.
Glucose
We dissolved 50 g of glucose in 200 ml water.
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.
Blank
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
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).
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).
Pomelo
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.
Insulin
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).
Interventions
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Pomelo
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.
Glucose
We dissolved 50 g of glucose in 200 ml water.
Blank
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
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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)
18 Years
70 Years
ALL
Yes
Sponsors
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Huazhong University of Science and Technology
OTHER
Responsible Party
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Xuefeng Yu
Director of Division of Endocrinology
Principal Investigators
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Xuefeng Yu, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology
Locations
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Tongji Hospital
Wuhan, Hubei, China
Countries
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Other Identifiers
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Tongji201201
Identifier Type: -
Identifier Source: org_study_id
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