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

NCT03909555 | Unknown DMC

• 1 other identifier: 20181015
• Study Type: observational
• Target: 777
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Continuous subcutaneous insulin infusion; chronic complications

Outcome Measures

Primary Outcomes (1)

• Difference in the proportions of chronic complications

  Difference in the proportions of macrovascular and microvascular complications between groups

  5 year

Secondary Outcomes (8)

• Difference of glycosylated hemoglobin A1C

  5 year

• Difference of fast blood glucose

  5 year

• Difference of C-peptides

  5 year

• Difference of insulin resistance

  5 year

• Difference of insulin usage

  5 year

Other Outcomes (1)

• New biomarkers which may indicate the occurrence of chronic complications of diabetes

  5 year

Study Arms (2)

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

Routine diabetic therapy

Received routine diabetic therapy

Other: Complications assessment

Interventions

Complications assessment OTHER

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; Short-term intensive insulin therapy

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangdong Provincial People's Hospital: collaborator
• Zhujiang Hospital: collaborator
• The Third Affiliated Hospital of Guangzhou Medical University: collaborator
• The Third Affiliated Hospital of Southern Medical University: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• First Affiliated Hospital of Jinan University: collaborator
• Guangzhou Red Cross Hospital: collaborator
• Dongguan Kanghua Hospital: collaborator

Study Sites (1)

endocrinology department of the first affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Jiewen Jin, Ph.D.

CONTACT

+8615298386724; jiewenjin_med@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endocrinology and Metabolism Department

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: April 10, 2019
• Study Start: June 1, 2019
• Primary Completion: June 30, 2021
• Study Completion: December 31, 2021
• Last Updated: April 10, 2019

Record last verified: 2019-03

Locations

CN (1)