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

Tracking Information

• First Submitted Date: December 5, 2013
• First Posted Date: December 10, 2013
• Results First Submitted Date: December 21, 2013
• Results First Posted Date: June 26, 2014
• Last Update Posted Date: June 26, 2014
• Study Start Date: January 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 25, 2014)

• 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.
• ∆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.
• ∆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.
• ∆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.
• 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.

• Original Primary Outcome Measures (submitted: December 9, 2013): glucose levels [ Time Frame: 9 days ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients
• Official Title: Glycemic Index & Glycemic Responses to Majia Pomelos
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
• Condition: Diabetes

Intervention

• 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
• 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
• 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

Study Arms

• 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.
  Interventions:

  • Dietary Supplement: Pomelo
  • Dietary Supplement: Glucose
  • Drug: met or diet
• 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.
  Interventions:

  • Dietary Supplement: Pomelo
  • Dietary Supplement: 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.
  Interventions:

  • Other: Blank
  • Drug: Insulin
• 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).
  Interventions:

  • Dietary Supplement: Pomelo
  • Drug: Insulin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 9, 2013): 59
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2013
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02006836
• Other Study ID Numbers: Tongji201201
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Xuefeng Yu, Huazhong University of Science and Technology
• Original Responsible Party: Same as current
• Current Study Sponsor: Huazhong University of Science and Technology
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Xuefeng Yu, PhD MD; Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology

• PRS Account: Huazhong University of Science and Technology
• Verification Date: April 2014