Type 2 DiabetesNCT03710811
Observational Study of Drug Naive Diabetes Receiving Insulin Therapy
An observational study of Type 2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Insulin
- Type of treatment
- Injection or infusion
- How many people
- 150 participants
- Where
- 2 sitesChina
- Study dates
- 1 Sep 2017to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: drug naive type 2 diabetes and healthy controls
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- cancer
- use of antibiotics in 3 months
- chronic digestive inflammations
- magnetic resonance imaging contraindications
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang
xiao ye, MD, 86-571-85893937
xiao ye, MD
- Recruiting
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Dalong Zhu, MD,PhD, 86-25-83-105302, zhudldr@gmail.com
Yan Bi, MD,PhD, 86-25-83-105302, biyan@nju.edu.cn
About this study
Official title: Observational Study of Drug Naive Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Insulin
- Keywords
- insulin, drug naive
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Continuous Subcutaneous Insulin Infusion
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes | drug naive Type 2 Diabetes received insulin therapy Receives: Drug: Insulin | |
| normal control | healthy volunteers as normal control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating immunity cell profiles
profiles of circulating immunity cells such as T cells
Measured: 7 days
Secondary outcomes (1)
skeletal muscle parameter
skeletal muscle parameters in magnetic resonance imaging
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start1 Sep 2017
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710811
- Sponsor's protocol ID
- INSULIN001
- Status last verified
- Oct 2018
- First submitted
- 15 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share
Publications
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.
PubMed 34894328Tang 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.
PubMed 31077529
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Drug Naive Type 2 Diabetes Receiving Continuous Subcutaneous Insulin Infusion Therapy
- ClinicalTrials.gov ID
- NCT03710811
- Acronym / sponsor ID
- INSULIN001
- Conditions
- Type 2 Diabetes
- Keywords
- insulin, drug naive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Collaborators
- Zhejiang Provincial People's Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2021 (estimated)
- First posted
- 18 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes | – | Drug: Insulindrug naive Type 2 Diabetes received insulin therapy |
| normal control | – | –healthy volunteers as normal control |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- drug naive type 2 diabetes and healthy controls
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InsulinContinuous Subcutaneous Insulin Infusion | Drug | Type 2 Diabetes |
Primary outcome
Circulating immunity cell profiles
Time frame: 7 days
profiles of circulating immunity cells such as T cells
1 secondary outcome
skeletal muscle parameter
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Derived from this study: PubMed 34894328Zhang 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.
- Derived from this study: PubMed 31077529Tang 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.
- Individual participant dataSharing planned: No. no plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating immunity cell profiles (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03710811, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.