Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome
Primary Purpose
Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Insulin, HbA1c, Exogenous Insulin Antibody Syndrome, Glucocorticoids
Eligibility Criteria
Inclusion Criteria:
- The diagnosis of type 2 diabetes was in accordance with the WHO diagnostic criteria of diabetes in 1999:fasting blood glucose ≥ 7.0mmol/l and / or blood glucose ≥ 11.1mmol/l in 2 hours after OGTT
- Aged between 30-60 years
- Positive detection of insulin antibody, hyperinsulinemia (refer to WHO standard in 1999, fasting insulin > 15 μ IU / ml or 2h postprandial insulin > 80 μ IU / ml)
- Type 2 diabetes mellitus patients who receiving insulin therapy
- Those meeting all the above standards can be included
Exclusion Criteria:
- Patients who had used animal insulin before the study
- Type 1 diabetes, gestational diabetes and special type diabetes
- Diabetic acute complications (ketoacidosis, hyperosmotic nonketotic coma, lactic acidosis) or serious chronic complications ; serious chronic complications (proliferative retinopathy, foot ulcer or gangrene, Complications of heart, brain and kidney)
- Patients with other serious heart disease, endocrine disease, autoimmune or chronic wasting disease
- Patients with severe primary diseases such as liver, kidney and hematopoietic system , Patients with psychosis
- Patients who are using or need to use thiol containing drugs in the near future
- Patients with severe insulin allergy
- Glucocorticoid contraindications (severe psychosis and epilepsy, active peptic ulcer or tuberculosis, recent gastrointestinal anastomosis, fracture, wound repair period, corneal ulcer, adrenocortical hyperfunction, severe hypertension, pregnant women, infection beyond the control of antibiotics, such as varicella, mould infection, etc.)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Glucocorticoid intervention group
Placebo control group
Arm Description
prednisone
placebo
Outcomes
Primary Outcome Measures
Number of patients with HbA1c <7% at 12 and 24 weeks
Secondary Outcome Measures
Blood glucose fluctuation at 4, 12 and 24 weeks
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04357392
Brief Title
Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome
Official Title
Study on the Effect of Glucocorticoid Intervention on the Improvement of Blood Glucose in Patients With Exogenous Insulin Antibody Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 20, 2020 (Anticipated)
Primary Completion Date
May 20, 2022 (Anticipated)
Study Completion Date
May 20, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
chenfengling
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs). Exogenous insulin antibody can cause blood glucose fluctuation, high blood glucose and refractory hypoglycemia, and have a serious impact on the health of diabetic patients. After adding glucocorticoid, some EIAs patients can reduce insulin dosage, correct hypoglycemia, even eliminate insulin antibody in about half a year, and achieve the goal of blood glucose stability. But up to now, there is no study to evaluate the improvement of blood glucose by glucocorticoid intervention in EIAS patients receiving insulin therapy. This project plans to collect 20 cases of EIAS and carry out a randomized, double-blind, placebo-controlled clinical trial to evaluate the improvement of blood glucose by glucocorticoid intervention.
Detailed Description
Diabetic patients who have long-term insulin used can product antibody against exogenous insulin, the investigators named this condition Exogenous insulin antibody syndrome (EIAs).Exogenous insulin antibody can lead to serious clinical consequences , such as blood glucose fluctuations, high blood glucose and refractory hypoglycemia, which is not only affect patients' blood glucose control, but also have a serious impact on the health of diabetic patients. Change to the oral antidiabetic drugs, change the insulin type or add glucocorticoids to the patients with serious disease are the main treatments. However, most of these treatment schemes are case reports, and there is no randomized controlled cohort study on the treatment scheme. The biosynthetic human insulin sequence is exactly the same as that of human insulin. Why do some diabetics have insulin antibody? The investigators speculated that insulin antibody production in some patients with EIAs is related to autoimmune disorder. After adding glucocorticoid, some EIAs patients can reduce insulin dosage, correct hypoglycemia, even eliminate insulin antibody in about half a year, and achieve the goal of blood glucose stability. However, there is no study to evaluate the effect of glucocorticoid intervention on the improvement of blood glucose in the EIAs population. This project plans to collect 20 cases of EIAs and carry out a randomized, double-blind, placebo-controlled clinical trial to evaluate the improvement of blood glucose by glucocorticoid intervention, so as to provide scientific basis for the standardized diagnosis and treatment of EIAs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Insulin, HbA1c, Exogenous Insulin Antibody Syndrome, Glucocorticoids
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double-blind, placebo-controlled, single center, pragmatic clinical trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Glucocorticoid intervention group
Arm Type
Experimental
Arm Description
prednisone
Arm Title
Placebo control group
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Prednisone
Other Intervention Name(s)
oral antidiabetic agents, insulin
Intervention Description
Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks
Primary Outcome Measure Information:
Title
Number of patients with HbA1c <7% at 12 and 24 weeks
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Blood glucose fluctuation at 4, 12 and 24 weeks
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The diagnosis of type 2 diabetes was in accordance with the WHO diagnostic criteria of diabetes in 1999:fasting blood glucose ≥ 7.0mmol/l and / or blood glucose ≥ 11.1mmol/l in 2 hours after OGTT
Aged between 30-60 years
Positive detection of insulin antibody, hyperinsulinemia (refer to WHO standard in 1999, fasting insulin > 15 μ IU / ml or 2h postprandial insulin > 80 μ IU / ml)
Type 2 diabetes mellitus patients who receiving insulin therapy
Those meeting all the above standards can be included
Exclusion Criteria:
Patients who had used animal insulin before the study
Type 1 diabetes, gestational diabetes and special type diabetes
Diabetic acute complications (ketoacidosis, hyperosmotic nonketotic coma, lactic acidosis) or serious chronic complications ; serious chronic complications (proliferative retinopathy, foot ulcer or gangrene, Complications of heart, brain and kidney)
Patients with other serious heart disease, endocrine disease, autoimmune or chronic wasting disease
Patients with severe primary diseases such as liver, kidney and hematopoietic system , Patients with psychosis
Patients who are using or need to use thiol containing drugs in the near future
Patients with severe insulin allergy
Glucocorticoid contraindications (severe psychosis and epilepsy, active peptic ulcer or tuberculosis, recent gastrointestinal anastomosis, fracture, wound repair period, corneal ulcer, adrenocortical hyperfunction, severe hypertension, pregnant women, infection beyond the control of antibiotics, such as varicella, mould infection, etc.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen
Phone
021-56691101-6271
Email
cfl1993@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen
Organizational Affiliation
The Ninth People's Hospital Affiliated to Shanghai Jiaotong University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD, all IPD that underlie results in a publication
IPD Sharing Time Frame
when summary data are published
Learn more about this trial
Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome
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