Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients

Huazhong University of Science and Technology

Status: Completed

Conditions: Diabetes

Treatments: Dietary Supplement: Pomelo; Other: Blank; Drug: met or diet; Dietary Supplement: Glucose; Drug: Insulin

Study type: Interventional

Funder types: Other

Identifiers

NCT02006836

Tongji201201

Details and patient eligibility

About

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).

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 4 patient groups

Diabetic

Other group

Description:

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.

Treatment:

Drug: met or diet

Dietary Supplement: Glucose

Dietary Supplement: Pomelo

Healthy

Other group

Description:

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.

Treatment:

Dietary Supplement: Glucose

Dietary Supplement: Pomelo

Diabetic 2 - without pomelo

Other group

Description:

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.

Treatment:

Drug: Insulin

Other: Blank

Diabetic 2 - with pomelo

Other group

Description:

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).

Treatment:

Drug: Insulin

Dietary Supplement: Pomelo