Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients
NCT ID: NCT02956655
Last Updated: 2016-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2016-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
Exercise
Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging
Lifestyle guidance
Lifestyle guidance is provided by specific physicians through phone calls
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.
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.
Exercise
Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging
Lifestyle guidance
Lifestyle guidance is provided by specific physicians through phone calls
H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland
Interventions
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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.
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.
Exercise
Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging
Lifestyle guidance
Lifestyle guidance is provided by specific physicians through phone calls
H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
70 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Jian Qin
director of the education department
Principal Investigators
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Jian Qin, Doctor
Role: STUDY_DIRECTOR
Sun Yat-sen University
Locations
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The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Jian Qin, Doctor
Role: primary
Other Identifiers
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2016NO.093
Identifier Type: -
Identifier Source: org_study_id