Observational Study of Drug Naive Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School2 sites in 1 country150 target enrollmentSeptember 1, 2017

ConditionsType 2 Diabetes

InterventionsInsulin

DrugsInsulin

Overview

Phase: Not Applicable
Intervention: Insulin
Conditions: Type 2 Diabetes
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment: 150
Locations: 2
Primary Endpoint: Circulating immunity cell profiles
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A multi-centre, open-label trial to investigate the efficacy and possible mechanism of Continuous Subcutaneous Insulin Infusion treatment in patients with drug naive type 2 diabetes.

Registry

clinicaltrials.gov

Start Date

September 1, 2017

End Date

August 30, 2021

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Responsible Party

Principal Investigator

Dalong Zhu

Doctor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Eligibility Criteria

Inclusion Criteria

•for type 2 diabetes:
•Male or female age ≧ 25 years and ≦75 years old
•HbA1c ≧8.0%
•for normal controls：
•Male or female age ≧ 25 years and ≦75 years old
•Normal glucose tolerance confirmed by oral glucose tolerance test

Exclusion Criteria

•Islet antibody positive
•Athletes, has a history of skeletal muscle injury ( trauma or surgery ), skeletal muscle wasting diseases ( such as mitochondrial myopathy, muscular atrophy, etc )
•Acute infection(such as cute upper respiratory infection, acute pneumonia)
•long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs
•consists with other endocrine diseases
•use of antibiotics in 3 months
•chronic digestive inflammations
•magnetic resonance imaging contraindications