Effect of Glucocorticoid on Exogenous Insulin Antibody Syndrome

NCT04357392 | Unknown Early Phase 1

• 1 other identifier: EIAS2020V4
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Insulin; HbA1c; Exogenous Insulin Antibody Syndrome; Glucocorticoids

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (1)

• Blood glucose fluctuation at 4, 12 and 24 weeks

  24 weeks

Study Arms (2)

Glucocorticoid intervention group

EXPERIMENTAL

prednisone

Drug: Prednisone

Placebo control group

PLACEBO COMPARATOR

placebo

Drug: Prednisone

Interventions

Prednisone DRUG

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

Also known as: oral antidiabetic agents, insulin

Glucocorticoid intervention group; Placebo control group

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• chenfengling: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Prednisone; Hypoglycemic Agents; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Chen

  The Ninth People's Hospital Affiliated to Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen

CONTACT

021-56691101-6271; cfl1993@126.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Model Details: Randomized, double-blind, placebo-controlled, single center, pragmatic clinical trial

Study Record Dates

• First Submitted: April 19, 2020
• First Posted: April 22, 2020
• Study Start: May 20, 2020
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2023
• Last Updated: April 24, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: when summary data are published