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Observational Study of Drug Naive Diabetes Receiving Insulin Therapy

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03710811
Enrollment
150
Registered
2018-10-18
Start date
2017-09-01
Completion date
2021-08-30
Last updated
2018-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

insulin, drug naive

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.

Interventions

DRUGInsulin

Continuous Subcutaneous Insulin Infusion

Sponsors

Zhejiang Provincial People's Hospital
CollaboratorOTHER
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Circulating immunity cell profiles7 daysprofiles of circulating immunity cells such as T cells

Secondary

MeasureTime frameDescription
skeletal muscle parameter7 daysskeletal muscle parameters in magnetic resonance imaging

Other

MeasureTime frameDescription
fasting blood glucose7 daysfasting blood glucose

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026