Back to results

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

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

30 Years - 60 Years (Adult)All SexesDoes not accept 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.)

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

NCT ID

NCT04357392

First Posted

April 19, 2020

Last Updated

April 22, 2020

Sponsor

chenfengling

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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

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

We'll reach out to this number within 24 hrs