Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients

The purpose of this study is to evaluate Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland; Other: Fasting therapy; Other: Exercise; Behavioral: Lifestyle guidance; Drug: Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk)

Detailed Description

This study was to investigate the effects of fasting therapy on blood glucose control and islet function in newly diagnosed type 2 diabetic patients.

60 participants will be recruited from outpatients or inpatients in First Affiliated Hospital of Sun Yat-sen University according the eligibility criteria. All the eligible subjects will be randomly allocated into 2 groups, the fasting group and the intense insulin therapy group. The former one will receive fasting therapy for 14 days and the latter be treated with an intense insulin therapy including short-term continuous subcutaneous insulin infusion treatment or four stage intensive insulin treatment for 2 weeks.

First of all, to determine whether fasting therapy is effective for glucose control or not, the investigators will observed the required time and control rate for a targeted glucose level, the average fasting blood glucose and postprandial blood glucose as well as the glucose amelioration degree in all the patients. Then, all the patients will undergo a follow-up period of 1 year, during which the fasting and postprandial blood glucose and glycosylated hemoglobin of each participant will be monitored to assess the long-term remission rate of diabetes. Patients are invited to review their glucose and lipid metabolic indices at 3 months, 6 months and 12 months of follow-up. Lifestyle guidance will be offered by specialist physicians throughout the follow-up period.

Secondly, all the patients are required to take the insulin and C-peptide releasing tests before and after fasting as well as in the follow-up to investigate the short-term and long-term treatment effect of islet function through accessing the first secretion function of pancreatic island and calculating insulin resistance(HOMA-IR) and HOMA-B through homeostasis model assessment.

In summary, this study aims to explore the short-term and long-term therapeutic effects in new onset type 2 diabetes, hoping to provide a novel, effective and more convenient treatment method for them.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • The First Affiliated Hospital of Sun Yat-sen University
      • Contact: Jian Qin, Doctor; Phone Number: 020-87330751; Email: himybox@yeah.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• aged from 27-65 years
• overweight or obese (body mass index[BMI] ≧25.0 kg/m2)
• The function of heart, liver, kidney is normal
• Newly diagnosed Type 2 diabetes according to the diagnostic criteria and classification of diabetes mellitus in 1999 World Health Organization standards with a fasting plasma glucose level ranged from 7.0 mmol/l to 16.7 mmol/l
• sign a consent form

Exclusion Criteria:

• Females who were pregnant or experiencing a menstrual period
• Abnormal function of heart, liver, kidney
• Aged below 25 or over 70
• Malignancy, hematopathy, active tuberculosis, peptic ulcer with gastric bleeding, binge-eating disorder, psychiatric disease, congestive heart failure, cancer or a history of cancer, unstable coronary artery disease
• With acute or severe chronic diabetic complications
• Without an informed consent
• Severe intercurrent illness
• Tested positive for glutamic acid decarboxylase antibody
• Patients with maturity onset diabetes in youth and mitochondria diabetes mellitus
• Other situations which the investigators think that it is inappropriate to include

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting therapy; Fasting therapy, lasting for 14 days, all subjects are isolated from ordinary food. However, drinking water is not limited and they are encouraged to drink more, at least 3 liters. Besides, they need to take some middle intensity exercise for at least 2 hours. They will take some prescribed medications except for hypoglycemic drugs.	Other: Fasting therapy; The target fasting plasma glucose is set below 6.1mmol/l and the postprandial blood glucose below 8.0 mmol/l. After intervention, all the accomplished patients undergo a 1 year period follow-up. Lifestyle guidance will be offered throughout the follow-up.; Other: Exercise; Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging; Behavioral: Lifestyle guidance; Lifestyle guidance is provided by specific physicians through phone calls
Active Comparator: Insulin intensive therapy; Insulin intensive therapy, receive continuous subcutaneous insulin infusion. (Human Insulin (Novolin-R, Novo Nordisk) Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland). The insulin dose used will be adjusted everyday according to their glucose by a physician until a target blood glucose level been reached.	Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland; Other: Exercise; Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging; Behavioral: Lifestyle guidance; Lifestyle guidance is provided by specific physicians through phone calls; Drug: Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk); Human Insulin (Novolin-R, Novo Nordisk) Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland The target fasting plasma glucose is set below 6.1mmol/l and the postprandial blood glucose below 8.0 mmol/l. If the glucose target cannot be achieved within 2 weeks or the subjects are not tolerated with this therapy, these members will be exclude from the study and they will receive other treatment according the standard treatment guidelines. After intervention, all the accomplished patients will undergo a 1 year period follow-up. Lifestyle guidance will be offered throughout the follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The remission rate of diabetes	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
β-cell function--HOMA-IR	HOMA means "Homeostasis model assessment". It is a designed model for evaluating the extent of individual's insulin resistance. The specific calculate formula is listed as follows, "fasting plasma glucose(mmol/l) × fasting insulin(mIU/L)/22.5". So it's a specific value without measurement. The normal value of it is 1. Higher than 1 indicate insulin resistance. HOMA-B refers to the basial pancreas islet function. The formula is "20 × fasting insulin / (fasting plasma glucose-3.5)". The measurement of it is percent(%). The normal value of it is 100%. The value of it will decrease when the patients's pancreas islet function is worse.	6 months
β-cell function--HOMA-B (%)	HOMA means "Homeostasis model assessment". It is a designed model for evaluating the extent of individual's insulin resistance. The specific calculate formula is listed as follows, "fasting plasma glucose(mmol/l) × fasting insulin(mIU/L)/22.5". So it's a specific value without measurement. The normal value of it is 1. Higher than 1 indicate insulin resistance. HOMA-B refers to the basial pancreas islet function. The formula is "20 × fasting insulin / (fasting plasma glucose-3.5)". The measurement of it is percent(%). The normal value of it is 100%. The value of it will decrease when the patients's pancreas islet function is worse.	6 months
Weight (kg)		before enrollment, after the intervention (at day 14th), 6 month after the intervention
BMI (kg/m^2)		before enrollment, after the intervention (at day 14th), 6 month after the intervention
Lipid profile (mmol/l)		before enrollment, after the intervention (at day 14th), 6 month after the intervention
Uric acid (mmol/l)		before enrollment, after the intervention (at day 14th), 6 month after the intervention

Collaborators and Investigators

• Sponsor: First Affiliated Hospital, Sun Yat-Sen University
• Investigators: Study Director: Jian Qin, Doctor, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: September 21, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 6, 2016

Study Record Updates

• Last Update Posted (Estimate): November 6, 2016
• Last Update Submitted That Met QC Criteria: November 4, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: 2016NO.093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO