Observational Study of Drug Naive Diabetes Receiving Insulin Therapy

• Conditions: Type 2 Diabetes
• Interventions: Drug: Insulin

• Registration Number: NCT03710811
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Status Verified: 2018-10
• Study First Submitted: 2018-10-15
• Study First Submitted QC: 2018-10-17
• Last Update Submitted: 2018-10-17
• Study First Posted: 2018-10-18
• Last Update Posted: 2018-10-18
• Primary Completion: 2020-08-30
• Study Completion: 2021-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

for type 2 diabetes:

1. Male or female age ≧ 25 years and ≦75 years old
2. HbA1c ≧8.0%
3. durg naive

for normal controls：

1. Male or female age ≧ 25 years and ≦75 years old
2. Normal glucose tolerance confirmed by oral glucose tolerance test

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes	Insulin	drug naive Type 2 Diabetes received insulin therapy

Primary Outcome Measures

Name	Time	Method
Circulating immunity cell profiles	7 days	profiles of circulating immunity cells such as T cells

Secondary Outcome Measures

Name	Time	Method
skeletal muscle parameter	7 days	skeletal muscle parameters in magnetic resonance imaging

Trial Locations

Locations (2)

at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China

Zhejiang Provincial People'S Hospital; 🇨🇳 Hangzhou, Zhejiang, China