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

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ClinicalTrials.gov Identifier: NCT02956655
Recruitment Status : Unknown
Verified November 2016 by Jian Qin, First Affiliated Hospital, Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
Jian Qin, First Affiliated Hospital, Sun Yat-Sen University

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Other: Fasting therapy Drug: Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk) Other: Exercise Behavioral: Lifestyle guidance Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients
Study Start Date : July 2016
Estimated Primary Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Insulin

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.
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



Primary Outcome Measures :
  1. The remission rate of diabetes [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. β-cell function--HOMA-IR [ Time Frame: 6 months ]
    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.

  2. β-cell function--HOMA-B (%) [ Time Frame: 6 months ]
    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.

  3. Weight (kg) [ Time Frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention ]
  4. BMI (kg/m^2) [ Time Frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention ]
  5. Lipid profile (mmol/l) [ Time Frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention ]
  6. Uric acid (mmol/l) [ Time Frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956655


Contacts
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Contact: Li Zhang, Master 15626490129 516700415@qq.com
Contact: Tingying Zhang, Master 15692025654 277968025@qq.com

Locations
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China, Guangdong
The First Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Jian Qin, Doctor    020-87330751    himybox@yeah.net   
Sponsors and Collaborators
First Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Director: Jian Qin, Doctor Sun Yat-sen University

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Responsible Party: Jian Qin, director of the education department, First Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02956655     History of Changes
Other Study ID Numbers: 2016NO.093
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs