Status:
UNKNOWN
Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome
Lead Sponsor:
chenfengling
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
30-60 years
Phase:
EARLY_PHASE1
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 a...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
May 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 20 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04357392
Start Date
May 20 2020
End Date
May 20 2023
Last Update
April 24 2020
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