Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The remission rate of diabetes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Fasting therapy (Other)
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.
干预措施: Exercise (Other)
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.
干预措施: Lifestyle guidance (Behavioral)
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.
干预措施: Exercise (Other)
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.
干预措施: Lifestyle guidance (Behavioral)
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.
干预措施: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland (Device)
结局指标
主要结局
The remission rate of diabetes
时间窗: 6 months
次要结局
- β-cell function--HOMA-B (%)(6 months)
- Lipid profile (mmol/l)(before enrollment, after the intervention (at day 14th), 6 month after the intervention)
- Weight (kg)(before enrollment, after the intervention (at day 14th), 6 month after the intervention)
- β-cell function--HOMA-IR(6 months)
- BMI (kg/m^2)(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)
研究者
Jian Qin
director of the education department
First Affiliated Hospital, Sun Yat-Sen University