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Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome

NCT04357392 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-04-24

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Prednisone

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

Sponsors & Collaborators

  • chenfengling

    lead OTHER

Principal Investigators

  • Chen · The Ninth People's Hospital Affiliated to Shanghai Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-20
Primary Completion
2022-05-20
Completion
2023-05-20

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04357392 on ClinicalTrials.gov