Observational Study of Drug Naive Diabetes Receiving Insulin Therapy
1 other identifier
observational
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
October 15, 2018
CompletedFirst Posted
Study publicly available on registry
October 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2021
CompletedOctober 18, 2018
October 1, 2018
3 years
October 15, 2018
October 17, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Circulating immunity cell profiles
profiles of circulating immunity cells such as T cells
7 days
Secondary Outcomes (1)
skeletal muscle parameter
7 days
Other Outcomes (1)
fasting blood glucose
7 days
Study Arms (2)
Type 2 Diabetes
drug naive Type 2 Diabetes received insulin therapy
normal control
healthy volunteers as normal control
Interventions
Eligibility Criteria
drug naive type 2 diabetes and healthy controls
You may qualify if:
- for type 2 diabetes:
- Male or female age ≧ 25 years and ≦75 years old
- HbA1c ≧8.0%
- durg naive
- for normal controls：
- Male or female age ≧ 25 years and ≦75 years old
- Normal glucose tolerance confirmed by oral glucose tolerance test
You may not qualify if:
- 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
- pregnancy
- cancer
- use of antibiotics in 3 months
- chronic digestive inflammations
- magnetic resonance imaging contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008, China
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, China
Related Publications (2)
Zhang W, Wang H, Liu F, Ye X, Tang W, Zhang P, Gu T, Zhu D, Bi Y. Effects of Early Intensive Insulin Therapy on Endothelial Progenitor Cells in Patients with Newly Diagnosed Type 2 Diabetes. Diabetes Ther. 2022 Apr;13(4):679-690. doi: 10.1007/s13300-021-01185-w. Epub 2021 Dec 11.
PMID: 34894328DERIVEDTang W, Zhang B, Wang H, Li M, Wang H, Liu F, Zhu D, Bi Y. Improved skeletal muscle energy metabolism relates to the recovery of beta cell function by intensive insulin therapy in drug naive type 2 diabetes. Diabetes Metab Res Rev. 2019 Oct;35(7):e3177. doi: 10.1002/dmrr.3177. Epub 2019 May 27.
PMID: 31077529DERIVED
Biospecimen
blood sample with DNA
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
October 15, 2018
First Posted
October 18, 2018
Study Start
September 1, 2017
Primary Completion
August 30, 2020
Study Completion
August 30, 2021
Last Updated
October 18, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share
no plan to share