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

NCT02956655 | Unknown

• 1 other identifier: 2016NO.093
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• The remission rate of diabetes

  6 months

Secondary Outcomes (6)

• β-cell function--HOMA-IR

  6 months

• β-cell function--HOMA-B (%)

  6 months

• Weight (kg)

  before enrollment, after the intervention (at day 14th), 6 month after the intervention

• BMI (kg/m^2)

  before enrollment, after the intervention (at day 14th), 6 month after the intervention

• Lipid profile (mmol/l)

  before enrollment, after the intervention (at day 14th), 6 month after the intervention

Study Arms (2)

Fasting therapy

EXPERIMENTAL

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; Other: Exercise; Behavioral: Lifestyle guidance

Insulin intensive therapy

ACTIVE COMPARATOR

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); Other: Exercise; Behavioral: Lifestyle guidance; Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland

Interventions

Fasting therapy OTHER

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.

Fasting therapy

Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk) DRUG

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.

Insulin intensive therapy

Exercise OTHER

Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging

Fasting therapy; Insulin intensive therapy

Lifestyle guidance BEHAVIORAL

Lifestyle guidance is provided by specific physicians through phone calls

Fasting therapy; Insulin intensive therapy

H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland DEVICE

Insulin intensive therapy

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin; Exercise

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jian Qin, Doctor

  Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Li Zhang, Master

CONTACT

15626490129; 516700415@qq.com

Tingying Zhang, Master

CONTACT

15692025654; 277968025@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of the education department

Study Record Dates

• First Submitted: September 21, 2016
• First Posted: November 7, 2016
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Last Updated: November 7, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)