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Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients

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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:
Information provided by (Responsible Party):
Xuefeng Yu, Huazhong University of Science and Technology

Study Description
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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).

Condition or disease Intervention/treatment Phase
Diabetes Dietary Supplement: Pomelo Dietary Supplement: Glucose Other: Blank Drug: Insulin Drug: met or diet Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Glycemic Index & Glycemic Responses to Majia Pomelos
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
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.
 Dietary Supplement: 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.
Other Names:
  • Majia pomelos
  • Citrus grandis cv. Majiayou

Dietary Supplement: Glucose
We dissolved 50 g of glucose in 200 ml water.
Other Name: Anhydrous glucose

Drug: 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 Names:
  • metformin
  • diet control
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.
 Dietary Supplement: 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.
Other Names:
  • Majia pomelos
  • Citrus grandis cv. Majiayou

Dietary Supplement: Glucose
We dissolved 50 g of glucose in 200 ml water.
Other Name: Anhydrous glucose
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.
 Other: 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.

Drug: 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).
Other Names:
  • 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).
 Dietary Supplement: 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.
Other Names:
  • Majia pomelos
  • Citrus grandis cv. Majiayou

Drug: 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).
Other Names:
  • Insulin aspart
  • NovoRapid


Outcome Measures
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Primary Outcome Measures :
  1. Glycemic Index [ Time Frame: 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.


  2. ∆g of Breakfast With/Without Pomelo [ Time Frame: 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.

  3. ∆g of Lunch With/Without Pomelo [ Time Frame: 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.

  4. ∆g of Dinner With/Without Pomelo [ Time Frame: 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.

  5. AUCs With/Without Pomelo [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02006836


Locations
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China, Hubei
Tongji Hospital
Wuhan, Hubei, China, 430030
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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Principal Investigator: Xuefeng Yu, PhD MD Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology
More Information
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Responsible Party: Xuefeng Yu, Director of Division of Endocrinology, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT02006836    
Other Study ID Numbers: Tongji201201
First Posted: December 10, 2013    Key Record Dates
Results First Posted: June 26, 2014
Last Update Posted: June 26, 2014
Last Verified: April 2014
Keywords provided by Xuefeng Yu, Huazhong University of Science and Technology:
glycemic index
glycemic response
diabetes
pomelo
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Metformin
 Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs