Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients

NCT ID: NCT02006836

Last Updated: 2014-06-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type OTHER

Pomelo

Intervention Type 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.

Glucose

Intervention Type DIETARY_SUPPLEMENT

We dissolved 50 g of glucose in 200 ml water.

met or diet

Intervention Type 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.

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.

Group Type OTHER

Pomelo

Intervention Type 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.

Glucose

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type OTHER

Blank

Intervention Type 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

Intervention Type 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).

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).

Group Type OTHER

Pomelo

Intervention Type 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.

Insulin

Intervention Type 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).

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.

Intervention Type DIETARY_SUPPLEMENT

Glucose

We dissolved 50 g of glucose in 200 ml water.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type OTHER

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).

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Majia pomelos Citrus grandis cv. Majiayou Anhydrous glucose Insulin aspart NovoRapid metformin diet control

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Xuefeng Yu

Director of Division of Endocrinology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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China

Other Identifiers

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Tongji201201

Identifier Type: -

Identifier Source: org_study_id

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