Type 2 Diabetes MellitusNCT03909555
Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Type 2 Diabetes
An observational study of Type 2 Diabetes Mellitus, run by Sun Yat-sen University at 1 site in China.
Trial summary
Short-term intensive insulin therapy (SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. On the other hand, intensive control of glucose and lifestyle modification are two key elements in preventing chronic complications, especially microvascular… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Complications assessment
- How many people
- 777 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2019to 31 Dec 2021
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes
Who may be able to join
- Diagnosed as type 2 diabetes for at least 5 years;
- When diagnosed as diabetes for the first time, aged between 25 and 65 years, body mass index (BMI) 22-35 kg/m2, fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl);
- Short-term intensive insulin therapy group: Patients received short-term intensive insulin therapy for 14 days when newly diagnosed as type 2 diabetes and induce glycemic remission.
- Routine diabetic therapy group: Patients received routine diabetic therapy as guideline indicated and never induce glycemic remission.
Who cannot join
- Type 1 diabetes or special type of diabetes;
- Acute complications of diabetes (including DKA, HHS and lactic acidosis) when diagnosed as diabetes;
- Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy when diagnosed as diabetes;
- Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment when diagnosed as diabetes;
- Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal; Hemoglobin <100 g/L or need regular blood transfusion;
- Use of drugs that may influence blood glucose within 12 weeks;
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- Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
- Uncontrolled endocrine gland dysfunction;
- Patients with mental or communication disorders;
- Chronic cardiac insufficiency, heart function class III and above;
- Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
- Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Patients With Type 2 Diabetes
Short-term intensive insulin therapy (SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. On the other hand, intensive control of glucose and lifestyle modification are two key elements in preventing chronic complications, especially microvascular neuropathy. However, no study reported the long-term effect of SIIT on the chronic complications. In this multi-center, case-control study, effects of SIIT on the proportion of long-term chronic complications as well as potential biomarkers were investigated.
In total, 777 patients with type 2 diabetes, including 259 patients who participated SIIT when diabetes was newly diagnosed and 518 patients who received routine diabetic therapy will be enrolled in 12 centers in China. After baseline assessments, all patients will undergo complications assessment, including records of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score. Primary endpoint is the difference in the proportions of macrovascular and microvascular complications between groups. Secondary endpoints include the difference of glucose control, insulin resistance, complexity of anti-diabetic therapy and self-management skills and quality of life between two groups. What's more, new biomarkers, which may indicate the occurrence of chronic complications of diabetes, such as circulating endothelial progenitor, β cell dysfunction, and T cells.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Complications assessment
- Keywords
- Type 2 diabetes mellitus, Continuous subcutaneous insulin infusion, chronic complications
- 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.
Complications assessmentOther
Records of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score.
| Study group | Role | What they receive |
|---|---|---|
| Short-term intensive insulin therapy | Patients who used to participated in short-term intensive insulin therapy for 14 days when diabetes was newly diagnosed Receives: Other: Complications assessment | |
| Routine diabetic therapy | Received routine diabetic therapy Receives: Other: Complications assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the proportions of chronic complications
Difference in the proportions of macrovascular and microvascular complications between groups
Measured: 5 year
Secondary outcomes (8)
Difference of glycosylated hemoglobin A1C
Difference of glycosylated hemoglobin A1C between groups
Measured: 5 year
Difference of fast blood glucose
Difference of fast blood glucose between groups
Measured: 5 year
Difference of C-peptides
Difference of fast C-peptides between groups.
Measured: 5 year
Difference of insulin resistance
Difference of HOMA2-IR between groups. HOMA2-IR is calculated by fast blood glucose and C-peptide according to formula proposed by DR Matthew (the software can be accessed at http://www.ocdem.ox.ac.uk).
Measured: 5 year
Difference of insulin usage
Compare the proportion of insulin usage (including rapidly acting insulin, regular insulin, long-acting insulin and premixed insulin) between groups
Measured: 5 year
Difference of oral anti-diabetic drugs usage
Compare the proportion of oral anti-diabetic drugs usage (including biguanides, sulfonylureas, Glinides, glucosidase inhibitors, thiazolidinediones, DPP 4 inhibitors, SGLT-2 inhibitor and their combination) between groups
Measured: 5 year
Difference of attitudes toward diabetes
Compare the score of Diabetes Care Profile questionnaire between groups. Patients were questioned about five aspects, including positive attitude, negative attitude, ability to care for their diabetes, belief in importance of care, and self-care adherence. Each statement included a 5-point ranking scale, ranging from strongly disagree (never) to strongly agree (always), with 3 points as neutral. Items under the subscales of positive attitude, care ability, importance of care, and self-care adherence scoring ≥4 points and items of negative attitude scoring≤2 points were designated as good performance, whereas the opposites were poor.
Measured: 5 year
Difference of quality of life
Compare the score of Diabetes quality of life (DQOL) between groups. The DQOL contains a total of 46 items, and all the items are categorized into one of the following four domains: life satisfaction (15 items), diabetes impact (20 items), social/vocational related worries (7 items), and diabetes related worries (4 items). The DQOL adopts a 5-point Likert scale for its response options. The scores range from 1, labeled as "very satisfied," to 5, labeled as "very dissatisfied," for items in the life satisfaction domain; from 1, labeled as "never impacted," to 5, labeled as "always impacted," for items in the diabetes impact domain; and from 1, labeled as "never worried," to 5, labeled as "always worried," for the social/vocational related and diabetes related worries domains. Higher score indicating better outcome.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start1 Jun 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion31 Dec 2021 (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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 777 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Zhujiang Hospital, The Third Affiliated Hospital of Guangzhou Medical University, The Third Affiliated Hospital of Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Jinan University, Guangzhou Red Cross Hospital, Dongguan Kanghua Hospital
- Responsible party
- Principal investigator, Yanbing Li, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909555
- Sponsor's protocol ID
- 20181015
- Status last verified
- Mar 2019
- First submitted
- 21 Jan 2019
- Last updated
- 10 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03909555
- Acronym / sponsor ID
- 20181015
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Continuous subcutaneous insulin infusion, chronic complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 777 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Guangdong Provincial People's Hospital, Zhujiang Hospital, The Third Affiliated Hospital of Guangzhou Medical University, The Third Affiliated Hospital of Southern Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Jinan University, Guangzhou Red Cross Hospital, Dongguan Kanghua Hospital
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 10 Apr 2019 (actual)
- 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.
Short-term intensive insulin therapy (SIIT) is able to reverse β cell dysfunction and induce glycemic remission in patients with newly diagnosed type 2 diabetes. On the other hand, intensive control of glucose and lifestyle modification are two key elements in preventing chronic complications, especially microvascular neuropathy. However, no study reported the long-term effect of SIIT on the chronic complications. In this multi-center, case-control study, effects of SIIT on the proportion of long-term chronic complications as well as potential biomarkers were investigated.
In total, 777 patients with type 2 diabetes, including 259 patients who participated SIIT when diabetes was newly diagnosed and 518 patients who received routine diabetic therapy will be enrolled in 12 centers in China. After baseline assessments, all patients will undergo complications assessment, including records of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score. Primary endpoint is the difference in the proportions of macrovascular and microvascular complications between groups. Secondary endpoints include the difference of glucose control, insulin resistance, complexity of anti-diabetic therapy and self-management skills and quality of life between two groups. What's more, new biomarkers, which may indicate the occurrence of chronic complications of diabetes, such as circulating endothelial progenitor, β cell dysfunction, and T cells.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term intensive insulin therapy | – | Other: Complications assessmentPatients who used to participated in short-term intensive insulin therapy for 14 days when diabetes was newly diagnosed |
| Routine diabetic therapy | – | Other: Complications assessmentReceived routine diabetic therapy |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes
Key inclusion criteria (4 listed)
- Diagnosed as type 2 diabetes for at least 5 years;
- When diagnosed as diabetes for the first time, aged between 25 and 65 years, body mass index (BMI) 22-35 kg/m2, fasting plasma glucose (FPG) between 7.0 mmol/l (126 mg/dl) and 16.7 mmol/l (300 mg/dl);
- Short-term intensive insulin therapy group: Patients received short-term intensive insulin therapy for 14 days when newly diagnosed as type 2 diabetes and induce glycemic remission.
- Routine diabetic therapy group: Patients received routine diabetic therapy as guideline indicated and never induce glycemic remission.
Key exclusion criteria (12 listed)
- Type 1 diabetes or special type of diabetes;
- Acute complications of diabetes (including DKA, HHS and lactic acidosis) when diagnosed as diabetes;
- Serious microvascular complications: proliferative stage of retinopathy; urine AER >300 mg/g or urine protein positive, quantification >0.5 g/d; uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy when diagnosed as diabetes;
- Severe macrovascular complications: acute cerebrovascular accident, acute coronary syndrome, vascular intervention for peripheral arterial disease or amputation requiring hospitalization within 12 months prior to enrollment when diagnosed as diabetes;
- Blood creatinine clearance less than 50 ml/min, alanine aminotransferase ≥2.5×upper limit of normal, total bilirubin ≥1.5×upper limit of normal; Hemoglobin <100 g/L or need regular blood transfusion;
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 |
|---|---|---|
| Complications assessmentRecords of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score. | Other | Routine diabetic therapy, Short-term intensive insulin therapy |
Primary outcome
Difference in the proportions of chronic complications
Time frame: 5 year
Difference in the proportions of macrovascular and microvascular complications between groups
8 secondary outcomes
Difference of glycosylated hemoglobin A1C
Time frame: 5 year
Difference of fast blood glucose
Time frame: 5 year
Difference of C-peptides
Time frame: 5 year
Difference of insulin resistance
Time frame: 5 year
Difference of insulin usage
Time frame: 5 year
Difference of oral anti-diabetic drugs usage
Time frame: 5 year
Difference of attitudes toward diabetes
Time frame: 5 year
Difference of quality of life
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by 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 4 inclusion and 12 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 10 Apr 2019. 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 Jiewen Jin, Ph.D. (+8615298386724, jiewenjin_med@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the proportions of chronic complications (time frame: 5 year). 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 10 Apr 2019.