Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Prednisone

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chen; Phone Number: 021-56691101-6271; Email: cfl1993@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. 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
2. Aged between 30-60 years
3. 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)
4. Type 2 diabetes mellitus patients who receiving insulin therapy
5. Those meeting all the above standards can be included

Exclusion Criteria:

1. Patients who had used animal insulin before the study
2. Type 1 diabetes, gestational diabetes and special type diabetes
3. 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)
4. Patients with other serious heart disease, endocrine disease, autoimmune or chronic wasting disease
5. Patients with severe primary diseases such as liver, kidney and hematopoietic system , Patients with psychosis
6. Patients who are using or need to use thiol containing drugs in the near future
7. Patients with severe insulin allergy
8. 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: insulin; oral antidiabetic agents
Placebo Comparator: Placebo control group; placebo	Drug: Prednisone; Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks; Other Names: insulin; oral antidiabetic agents

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with HbA1c <7% at 12 and 24 weeks	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood glucose fluctuation at 4, 12 and 24 weeks	24 weeks

Collaborators and Investigators

• Sponsor: chenfengling
• Investigators: Principal Investigator: Chen, The Ninth People's Hospital Affiliated to Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 20, 2020
• Primary Completion (Anticipated): May 20, 2022
• Study Completion (Anticipated): May 20, 2023

Study Registration Dates

• First Submitted: April 19, 2020
• First Submitted That Met QC Criteria: April 19, 2020
• First Posted (Actual): April 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Insulin; HbA1c; Glucocorticoids; Exogenous Insulin Antibody Syndrome
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hypoglycemic Agents; Prednisone
• Other Study ID Numbers: EIAS2020V4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD, all IPD that underlie results in a publication
• IPD Sharing Time Frame: when summary data are published
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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