Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03909555
Recruitment Status : Unknown
Verified March 2019 by Yanbing Li, Sun Yat-sen University.
Recruitment status was:  Not yet recruiting
First Posted : April 10, 2019
Last Update Posted : April 10, 2019
Sponsor:
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 of Southern Medical University
First Affiliated Hospital of Jinan University
Guangzhou Red Cross Hospital
Dongguan Kanghua Hospital
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University

Brief 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 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.


Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Other: Complications assessment

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 777 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Patients With Type 2 Diabetes
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
Short-term intensive insulin therapy
Patients who used to participated in short-term intensive insulin therapy for 14 days when diabetes was newly diagnosed
Other: Complications assessment
Records of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score.

Routine diabetic therapy
Received routine diabetic therapy
Other: Complications assessment
Records of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score.




Primary Outcome Measures :
  1. Difference in the proportions of chronic complications [ Time Frame: 5 year ]
    Difference in the proportions of macrovascular and microvascular complications between groups


Secondary Outcome Measures :
  1. Difference of glycosylated hemoglobin A1C [ Time Frame: 5 year ]
    Difference of glycosylated hemoglobin A1C between groups

  2. Difference of fast blood glucose [ Time Frame: 5 year ]
    Difference of fast blood glucose between groups

  3. Difference of C-peptides [ Time Frame: 5 year ]
    Difference of fast C-peptides between groups.

  4. Difference of insulin resistance [ Time Frame: 5 year ]
    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).

  5. Difference of insulin usage [ Time Frame: 5 year ]
    Compare the proportion of insulin usage (including rapidly acting insulin, regular insulin, long-acting insulin and premixed insulin) between groups

  6. Difference of oral anti-diabetic drugs usage [ Time Frame: 5 year ]
    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

  7. Difference of attitudes toward diabetes [ Time Frame: 5 year ]
    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.

  8. Difference of quality of life [ Time Frame: 5 year ]
    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.


Other Outcome Measures:
  1. New biomarkers which may indicate the occurrence of chronic complications of diabetes [ Time Frame: 5 year ]
    Proportion of circulating endothelial progenitor cells between groups. Low level of circulating endothelial progenitor cells indicating a worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with type 2 diabetes
Criteria

Inclusion Criteria:

  1. Diagnosed as type 2 diabetes for at least 5 years;
  2. 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);
  3. 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.
  4. Routine diabetic therapy group: Patients received routine diabetic therapy as guideline indicated and never induce glycemic remission.

Exclusion Criteria:

  1. Type 1 diabetes or special type of diabetes;
  2. Acute complications of diabetes (including DKA, HHS and lactic acidosis) when diagnosed as diabetes;
  3. 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;
  4. 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;
  5. 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;
  6. Use of drugs that may influence blood glucose within 12 weeks;
  7. Systemic infection or serious concomitant disease; patients with malignancy or chronic diarrhea;
  8. Uncontrolled endocrine gland dysfunction;
  9. Patients with mental or communication disorders;
  10. Chronic cardiac insufficiency, heart function class III and above;
  11. Pregnant women, lactating women and women of child bearing age who are not willing to take contraception during the study;
  12. Subjects who don't cooperate, cannot be followed up or have difficulty in completing the study considered by the investigator.

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): NCT03909555


Contacts
Layout table for location contacts
Contact: Jiewen Jin, Ph.D. +8615298386724 jiewenjin_med@163.com

Locations
Layout table for location information
China, Guangdong
endocrinology department of the first affiliated hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Sun Yat-sen University
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 of Southern Medical University
First Affiliated Hospital of Jinan University
Guangzhou Red Cross Hospital
Dongguan Kanghua Hospital
Additional Information:

Layout table for additonal information
Responsible Party: Yanbing Li, Director of Endocrinology and Metabolism Department, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03909555    
Other Study ID Numbers: 20181015
First Posted: April 10, 2019    Key Record Dates
Last Update Posted: April 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yanbing Li, Sun Yat-sen University:
Type 2 diabetes mellitus
Continuous subcutaneous insulin infusion
chronic complications
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases