Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome

Sponsor

chenfengling (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04357392

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Prednisone	Early Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, double-blind, placebo-controlled, single center, pragmatic clinical trialRandomized, double-blind, placebo-controlled, single center, pragmatic clinical trial

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Study on the Effect of Glucocorticoid Intervention on the Improvement of Blood Glucose in Patients With Exogenous Insulin Antibody Syndrome

Anticipated Study Start Date :

May 20, 2020

Anticipated Primary Completion Date :

May 20, 2022

Anticipated Study Completion Date :

May 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Glucocorticoid intervention group prednisone	Drug: Prednisone Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks Other Names: oral antidiabetic agents insulin
Placebo Comparator: Placebo control group placebo	Drug: Prednisone Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks Other Names: oral antidiabetic agents insulin

Arm

Intervention/Treatment

Experimental: Glucocorticoid intervention group

prednisone

Drug: Prednisone

Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks

Other Names:

oral antidiabetic agents

insulin

Placebo Comparator: Placebo control group

placebo

Drug: Prednisone

Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks

Other Names:

oral antidiabetic agents

insulin

Outcome Measures

Primary Outcome Measures

Number of patients with HbA1c <7% at 12 and 24 weeks [24 weeks]

Secondary Outcome Measures

Blood glucose fluctuation at 4, 12 and 24 weeks [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)