Glycemic Responses to Majia Pomelos in Type 2 Diabetic Patients

NCT02006836 | Completed Results DMC

• 1 other identifier: Tongji201201
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes

Keywords

glycemic index; glycemic response; diabetes; pomelo

Outcome Measures

Primary Outcomes (5)

• Glycemic Index

  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.

  3 days

• ∆g of Breakfast With/Without Pomelo

  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.

  9 days

• ∆g of Lunch With/Without Pomelo

  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.

  9 days

• ∆g of Dinner With/Without Pomelo

  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.

  9 days

• AUCs With/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. 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.

  9 days

Study Arms (4)

Diabetic

OTHER

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; Dietary Supplement: Glucose; Drug: met or diet

Healthy

OTHER

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; Dietary Supplement: Glucose

Diabetic 2 - without pomelo

OTHER

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; Drug: Insulin

Diabetic 2 - with pomelo

OTHER

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; Drug: Insulin

Interventions

Pomelo 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.

Also known as: Majia pomelos, Citrus grandis cv. Majiayou

Diabetic; Diabetic 2 - with pomelo; Healthy

Glucose DIETARY_SUPPLEMENT

We dissolved 50 g of glucose in 200 ml water.

Also known as: Anhydrous glucose

Diabetic; Healthy

Blank 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.

Diabetic 2 - without pomelo

Insulin 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).

Also known as: Insulin aspart, NovoRapid

Diabetic 2 - with pomelo; Diabetic 2 - without pomelo

met or diet 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.

Also known as: metformin, diet control

Diabetic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In the diabetic and diabetic 2 groups, it required that their diabetes was controlled (HbA1c ≤ 8%) on diet with or without metformin.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Glucose; Insulin; Insulin Aspart; Proto-Oncogene Proteins c-met; Diet; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Short-Acting; Receptor Protein-Tyrosine Kinases; Protein-Tyrosine Kinases; Protein Kinases; Phosphotransferases (Alcohol Group Acceptor); Phosphotransferases; Transferases; Enzymes; Enzymes and Coenzymes; Intracellular Signaling Peptides and Proteins; Proteins; Receptors, Cell Surface; Membrane Proteins; Receptors, Growth Factor; Receptors, Peptide; Proto-Oncogene Proteins; Oncogene Proteins; Neoplasm Proteins; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr.Yu
• Organization: Huazhong University of Science and Technology

xfyu188@163.com

862783662883

Study Officials

• Xuefeng Yu, PhD MD

  Division of Endocrinology, Tongji Hospital, Huazhong University of Science & Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Division of Endocrinology

Study Record Dates

• First Submitted: December 5, 2013
• First Posted: December 10, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 26, 2014
• Results First Posted: June 26, 2014

Record last verified: 2014-04

Locations

CN (1)