Type 2 DiabetesNCT05752851
The Alteration of Gut Microbiota and Analysis of Related Factors in Newly Diagnosed Type 2 Diabetes Patients
An observational study of Type 2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
This Study aims to compare the characteristics of gut microbiota between the newly diagnosed T2DM and healthy subjects, and analysis the related clinical indicators that may affect the composition of gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Jul 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: T2DM patients who are not treated with any hypoglycemic drugs visited in the Department of Endocrinology at the Nanjing First Hospital from January 2023 to March 2023 were enrolled in this study.
Who may be able to join
- 1）18-65 years old 2）have no history of diabetes 3）fasting blood glucose <5.6 mmol/L 4) HbA1c<6.0%.
Who cannot join
- 1）BMI≥28kg/m2 2) People with type 1 diabetes, special type diabetes and pregnancy diabetes 3) Use antispasmodics, expanders, probiotics, prebiotics, antibacterial drugs or other drugs that affect intestinal microorganisms in the past month 4) Having inflammation, tumor, ulcer and other intestinal organic diseases, tumor, etc 5) History of abdominal surgery or gastrointestinal surgery 6) Suffer from mental illness or alcoholism, drug abuse or drug abuse. 7) Combined with other serious systemic diseases, such as cardiovascular disease, digestive disease, endocrine disease, skin disease, autoimmune disease, tumor, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First hospital
Nanjing, Jiangsu, 210006
Jianhua Ma, Profseeor, +8618951670116, majianhua196503@126.com
About this study
Official title: Nanjing First Hospital，Nanjing Medical University
This Study aims to compare the characteristics of gut microbiota between the newly diagnosed T2DM and healthy subjects, and analysis the related clinical indicators that may affect the composition of gut microbiota.
Read the detailed description
Previous studies have shown that gut microbiota imbalance is closely related to a variety of diseases, such as inflammatory bowel diseases (IBD), colorectal cancer (CRC), Alzheimer's disease (AD) and cardiovascular diseases. In recent years, more and more studies have found that gut microbiota plays an important role in chronic metabolic diseases such as obesity, fatty liver and diabetes. gut microbiota disorder may lead to insulin resistance，pancreatic islets injury and disorder of glycolipid metabolism through multiple metabolic pathways such as endotoxin, short chain fatty acids, bile acids, amino acids, promote the occurrence and development of T2DM. At present, there are relatively few population-based studies to assess the relationship between gut microbiota and diabetes, and the results are inconsistent or even contradictory, which may be due to the influence of the research population, disease status, diet, drugs and even detection technology. Therefore, the purpose of this study is to explore the difference of intestinal microbial characteristics between the initially diagnosed T2DM and the control group by using 16S rRNA gene sequencing analysis technology, so as to increase the understanding of the possible relationship between T2DM and intestinal microbiota, and provide theoretical support and direction guidance for the future biological treatment of diabetes.
- Conditions
- Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T2DM group | Collect stool and blood samples，No drugs use. | |
| Control group | Collect stool and blood samples，No drugs use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal 16S rRNA gene sequencing
Fecal 16S rRNA gene sequencing results of two group
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Feb 2023
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe 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-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05752851
- Sponsor's protocol ID
- KY20230116-10
- Status last verified
- Jan 2023
- First submitted
- 21 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nanjing First Hospital，Nanjing Medical University
- ClinicalTrials.gov ID
- NCT05752851
- Acronym / sponsor ID
- KY20230116-10
- Conditions
- Type 2 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 3 Mar 2023 (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.
This Study aims to compare the characteristics of gut microbiota between the newly diagnosed T2DM and healthy subjects, and analysis the related clinical indicators that may affect the composition of gut microbiota.
Detailed description
Previous studies have shown that gut microbiota imbalance is closely related to a variety of diseases, such as inflammatory bowel diseases (IBD), colorectal cancer (CRC), Alzheimer's disease (AD) and cardiovascular diseases. In recent years, more and more studies have found that gut microbiota plays an important role in chronic metabolic diseases such as obesity, fatty liver and diabetes. gut microbiota disorder may lead to insulin resistance，pancreatic islets injury and disorder of glycolipid metabolism through multiple metabolic pathways such as endotoxin, short chain fatty acids, bile acids, amino acids, promote the occurrence and development of T2DM. At present, there are relatively few population-based studies to assess the relationship between gut microbiota and diabetes, and the results are inconsistent or even contradictory, which may be due to the influence of the research population, disease status, diet, drugs and even detection technology. Therefore, the purpose of this study is to explore the difference of intestinal microbial characteristics between the initially diagnosed T2DM and the control group by using 16S rRNA gene sequencing analysis technology, so as to increase the understanding of the possible relationship between T2DM and intestinal microbiota, and provide theoretical support and direction guidance for the future biological treatment of diabetes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM group | – | –Collect stool and blood samples，No drugs use. |
| Control group | – | –Collect stool and blood samples，No drugs use. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- T2DM patients who are not treated with any hypoglycemic drugs visited in the Department of Endocrinology at the Nanjing First Hospital from January 2023 to March 2023 were enrolled in this study.
Key inclusion criteria (1 listed)
- 1）18-65 years old 2）have no history of diabetes 3）fasting blood glucose <5.6 mmol/L 4) HbA1c<6.0%.
Key exclusion criteria (1 listed)
- 1）BMI≥28kg/m2 2) People with type 1 diabetes, special type diabetes and pregnancy diabetes 3) Use antispasmodics, expanders, probiotics, prebiotics, antibacterial drugs or other drugs that affect intestinal microorganisms in the past month 4) Having inflammation, tumor, ulcer and other intestinal organic diseases, tumor, etc 5) History of abdominal surgery or gastrointestinal surgery 6) Suffer from mental illness or alcoholism, drug abuse or drug abuse. 7) Combined with other serious systemic diseases, such as cardiovascular disease, digestive disease, endocrine disease, skin disease, autoimmune disease, tumor, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal 16S rRNA gene sequencing
Time frame: Day one
Fecal 16S rRNA gene sequencing results of two group
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Individual participant dataSharing planned: Undecided
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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.
Jianhua Ma principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site 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 Nanjing First Hospital, Nanjing Medical University at 1 site 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 1 inclusion and 1 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 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Jianhua Jianhua, Doctor (+862552887091 ext. +861895167011, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal 16S rRNA gene sequencing (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2023.