Type 2 Diabetes MellitusNCT02956655
Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients
A study testing Fasting therapy, Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk) and Exercise in people with Type 2 Diabetes Mellitus, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Fasting therapy, Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk) and Exercise
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
Jian Qin, Doctor, 020-87330751, himybox@yeah.net
About this study
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Fasting therapy, Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk), Exercise, Lifestyle guidance, H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting therapyOther
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)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.
ExerciseOther
Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging
Lifestyle guidanceBehavioural
Lifestyle guidance is provided by specific physicians through phone calls
H-Tron Plus V100; Disetronic Medical System, Burgdorf, SwitzerlandDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The remission rate of diabetes
Measured: 6 months
Secondary outcomes (6)
β-cell function--HOMA-IR
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.
Measured: 6 months
β-cell function--HOMA-B (%)
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.
Measured: 6 months
Weight (kg)
Measured: before enrollment, after the intervention (at day 14th), 6 month after the intervention
BMI (kg/m^2)
Measured: before enrollment, after the intervention (at day 14th), 6 month after the intervention
Lipid profile (mmol/l)
Measured: before enrollment, after the intervention (at day 14th), 6 month after the intervention
Uric acid (mmol/l)
Measured: before enrollment, after the intervention (at day 14th), 6 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital, Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Qin, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Jian Qin, Doctor, Study director, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956655
- Sponsor's protocol ID
- 2016NO.093
- Status last verified
- Nov 2016
- First submitted
- 21 Sep 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fasting Therapy on Blood Glucose Control and Islet Function in Newly Diagnosed Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT02956655
- Acronym / sponsor ID
- 2016NO.093
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jul 2017 (estimated)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasting therapy | Experimental | Other: Fasting therapy, Other: Exercise, Behavioral: Lifestyle guidanceFasting 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. |
| Insulin intensive therapy | Active comparator | Drug: Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk), Other: Exercise, Behavioral: Lifestyle guidance, Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, SwitzerlandInsulin 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting therapyThe 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 | Fasting therapy |
| 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. | Drug | Insulin intensive therapy |
| ExerciseMiddle intense exercise for at least 2 hours,e.g. brisk walking or jogging | Other | Fasting therapy, Insulin intensive therapy |
| Lifestyle guidanceLifestyle guidance is provided by specific physicians through phone calls | Behavioural | Fasting therapy, Insulin intensive therapy |
| H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland | Device | Insulin intensive therapy |
Primary outcome
The remission rate of diabetes
Time frame: 6 months
6 secondary outcomes
β-cell function--HOMA-IR
Time frame: 6 months
β-cell function--HOMA-B (%)
Time frame: 6 months
Weight (kg)
Time frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
BMI (kg/m^2)
Time frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
Lipid profile (mmol/l)
Time frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
Uric acid (mmol/l)
Time frame: before enrollment, after the intervention (at day 14th), 6 month after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Qin, Doctor study director
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting therapy, Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk) and Exercise in people with Type 2 Diabetes Mellitus, run by First Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zhang, Master (15626490129, 516700415@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The remission rate of diabetes (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2016.