Observational Study of Drug Naive Diabetes Receiving Insulin Therapy

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03710811
• Other study ID #: INSULIN001
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: August 30, 2021

Study information

• Verified date: October 2018
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: August 30, 2021
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• Insulin
Continuous Subcutaneous Insulin Infusion

Locations

Country	Name	City	State
China	Zhejiang Provincial People'S Hospital	Hangzhou	Zhejiang
China	at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Zhejiang Provincial People’s Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	fasting blood glucose	fasting blood glucose	7 days
Primary	Circulating immunity cell profiles	profiles of circulating immunity cells such as T cells	7 days
Secondary	skeletal muscle parameter	skeletal muscle parameters in magnetic resonance imaging	7 days