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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02956655
• Other study ID #: 2016NO.093
• Status: Recruiting
• Phase: N/A
• First received: September 21, 2016
• Last updated: November 4, 2016
• Start date: July 2016

Study information

• Verified date: November 2016
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Li Zhang, Master
• Phone: 15626490129
• Email: 516700415[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.

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.

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

Device:
• H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The remission rate of diabetes		6 months	Yes
Secondary	ß-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	Yes
Secondary	ß-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	Yes
Secondary	Weight (kg)		before enrollment, after the intervention (at day 14th), 6 month after the intervention	No
Secondary	BMI (kg/m^2)		before enrollment, after the intervention (at day 14th), 6 month after the intervention	No
Secondary	Lipid profile (mmol/l)		before enrollment, after the intervention (at day 14th), 6 month after the intervention	No
Secondary	Uric acid (mmol/l)		before enrollment, after the intervention (at day 14th), 6 month after the intervention	No