Clinical trial NCT02956655: Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients
Official title: Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2016-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The remission rate of diabetes
timeFrame: 6 months
Secondary outcomes:
measure: β-cell function--HOMA-IR
timeFrame: 6 months
measure: β-cell function--HOMA-B (%)
timeFrame: 6 months
measure: Weight (kg)
timeFrame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
measure: BMI (kg/m^2)
timeFrame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
measure: Lipid profile (mmol/l)
timeFrame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
measure: Uric acid (mmol/l)
timeFrame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Jian Qin, Doctor
role: STUDY_DIRECTOR
References: