Observational Study of Drug Naive Diabetes Receiving Insulin Therapy

Nanjing University

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin

Study type: Observational

Funder types: Other

Identifiers

NCT03710811

INSULIN001

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

Type 2 Diabetes

Description:

drug naive Type 2 Diabetes received insulin therapy

Treatment:

Drug: Insulin

normal control

Description:

healthy volunteers as normal control