Type 2 Diabetes MellitusNCT03377946
Effect of Probiotics on Pre-diabetes and Diabetes in China
A study testing probiotics in people with Type 2 Diabetes Mellitus, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- probiotics
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 21 Dec 2017to 31 Aug 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet Diabetes/pre-diabetes diagnostic criteria
- BMI 18-35kg/m2
Who cannot join
- Patients with diabetes or hyperlipidemia, and need regular use of drugs.
- Secondary obesity or diabetes
- Digestive, tumor, heart, lung, kidney, rheumatic immunity and other systemic serious diseases
- Pregnant women, women ready for pregnancy, and nursing mothers
- Take antibiotics or bacterial agents within 1 month
- Diarrhea or abscess in 1 month or blood or other abnormal feces
- Diabetics have a history of more than 2 years
- The OGTT experiment of diabetic patients FG≥9mmol/L or 2h≥14mmol/L
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
health management center,Southwest hospital
Chongqing, Chongqing Municipality, 400030
Ya lan zhang, MD, 13594348611, 281072454@qq.com
xiao lan zhao, MD, 13608303976, zhaoxiaolan65@126.com
About this study
Official title: Effect of Probiotics on Pre-diabetes and Diabetes in China-the Role of Gut Microbiota Composition
This study is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.
Read the detailed description
Methods: double-blind, randomized controlled trial. Number of participants: 160 patients with pre-diabetes and 60 diabetes. Intervention time: 3months. Data and Specimen collection time: at baseline and after the intervention.
Observation index
- Physical measurement: gender, age, weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, systolic pressure, diastolic blood pressure.
- Lifestyle questionnaire: diet, drinking, exercise, sleep and other habits.
- Blood test: blood glucose, OGTT, blood lipid, TNF-a, il-6, il-10, LPS, glp-1, gut microbiome metabolism products, T2DM related methylation.
- Gut microbiome detection: gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- probiotics, placebo
- Keywords
- pre-diabetes,diabetes,probiotics
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticsBiological
the probiotics group was taking probiotics 4 packets a day
placeboBiological
the placebo group was taking placebo 4 packets a day
| Study group | Role | What they receive |
|---|---|---|
| probiotics on type 2 diabetes | Experimental | take probiotics Receives: Biological: probiotics |
| probiotics on pre-diabetes | Experimental | take probiotics Receives: Biological: probiotics |
| placebo on type 2 diabetes | Placebo comparator | take placebo Receives: Biological: placebo |
| placebo on pre-diabetes | Placebo comparator | take placebo Receives: Biological: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of blood glucose and insulin sensitivity
blood glucose of fasting and 2 hours after OGTT，fasting insulin
Measured: 3~5 years
Changes of gut microbiota composition
Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
Measured: 3~5 years
Secondary outcomes (3)
Changes of blood inflammatory markers
blood TNF-a, Il-6, Il-10, LPS
Measured: 3~5 years
Composite changes in diabetes risk factors
blood pressure, triglyceride,Cholesterol,LDL,HDL, weight
Measured: 3~5 years
Composite changes of weight, waist circumference and BMI
weight, waist circumference,BMI,body fat
Measured: 3~5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start21 Dec 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Zeng, Chinese PLA General Hospital
- Investigators
- Qiang Zeng, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377946
- Sponsor's protocol ID
- CHPF2017019
- Status last verified
- Dec 2017
- First submitted
- 10 Dec 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotics on Pre-diabetes and Diabetes in China-the Role of Gut Microbiota Composition
- ClinicalTrials.gov ID
- NCT03377946
- Acronym / sponsor ID
- CHPF2017019
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- pre-diabetes,diabetes,probiotics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 21 Dec 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 19 Dec 2017 (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 is aimed at verifying the effects of probiotics (KAWAI:dead S.thermophilus) on glucos management among T2DM and pre-diabetes Chinese adult. Additionally, the investigators intend to verify the effects of probiotics on modifying the structure and function of gut microbiome.
Detailed description
Methods: double-blind, randomized controlled trial. Number of participants: 160 patients with pre-diabetes and 60 diabetes. Intervention time: 3months. Data and Specimen collection time: at baseline and after the intervention.
Observation index
- Physical measurement: gender, age, weight, BMI, waist circumference, hip circumference, waist-to-hip ratio, systolic pressure, diastolic blood pressure.
- Lifestyle questionnaire: diet, drinking, exercise, sleep and other habits.
- Blood test: blood glucose, OGTT, blood lipid, TNF-a, il-6, il-10, LPS, glp-1, gut microbiome metabolism products, T2DM related methylation.
- Gut microbiome detection: gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| probiotics on type 2 diabetes | Experimental | Biological: probioticstake probiotics |
| probiotics on pre-diabetes | Experimental | Biological: probioticstake probiotics |
| placebo on type 2 diabetes | Placebo comparator | Biological: placebotake placebo |
| placebo on pre-diabetes | Placebo comparator | Biological: placebotake placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Meet Diabetes/pre-diabetes diagnostic criteria
- BMI 18-35kg/m2
Key exclusion criteria (8 listed)
- Patients with diabetes or hyperlipidemia, and need regular use of drugs.
- Secondary obesity or diabetes
- Digestive, tumor, heart, lung, kidney, rheumatic immunity and other systemic serious diseases
- Pregnant women, women ready for pregnancy, and nursing mothers
- Take antibiotics or bacterial agents within 1 month
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 |
|---|---|---|
| probioticsthe probiotics group was taking probiotics 4 packets a day | Biological | probiotics on pre-diabetes, probiotics on type 2 diabetes |
| placebothe placebo group was taking placebo 4 packets a day | Biological | placebo on pre-diabetes, placebo on type 2 diabetes |
Primary outcome
Changes of blood glucose and insulin sensitivity
Time frame: 3~5 years
blood glucose of fasting and 2 hours after OGTT，fasting insulin
Changes of gut microbiota composition
Time frame: 3~5 years
Feces gut microbiome 16Sr DNA sequencing, gut microbiome bioinformatics analysis
3 secondary outcomes
Changes of blood inflammatory markers
Time frame: 3~5 years
Composite changes in diabetes risk factors
Time frame: 3~5 years
Composite changes of weight, waist circumference and BMI
Time frame: 3~5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
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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.
Qiang Zeng, MD principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics in people with Type 2 Diabetes Mellitus, run by Chinese PLA General Hospital 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 2 inclusion and 8 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 19 Dec 2017. 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. Some participants in this study may receive a placebo. 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 Fei Wang, MD (+86-10-68295950, wangfei301hmi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of blood glucose and insulin sensitivity (time frame: 3~5 years). The study lists 2 primary outcomes in all. 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 19 Dec 2017.