Type 2 DiabetesNCT02650830
Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress
An observational study of Type 2 Diabetes and Prediabetes, run by Yonsei University at 1 site in South Korea.
Trial summary
"The goal of this work is to critically test the hypothesis that there exists a different profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with normal controls. Read more about this study
- Who is it for?
- Ages 19 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Prediabetes, Non-alcoholic Fatty Liver Disease
- How many people
- 362 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Sep 2015to 2 Jul 2018
- 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 19 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.
Who may be able to join
- pre-diabetes 1. defined according to the ADA guideline (prediabetes definition) FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) or 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) or A1C 5.7-6.4% (39-46 mmol/mol)
- type 2 diabetes 1. defined according to the ADA guideline (DM definition) FPG ≥126 mg/dL (7.0 mmol/L) or 2-h PG ≥200 mg/dL (11.1 mmol/L) in the 75-g OGTT or A1C ≥6.5% (48 mmol/mol) or In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L) or 2. taking any anti-diabetic medications
- Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI <25kg/m2
Who cannot join
- subjects who refused to agree with informed consents
- subjects with organ-transplantation
- pregnant women
- type 1 diabetes -
Trial locations and contacts
1 site in 1 country.
About this study
"The goal of this work is to critically test the hypothesis that there exists a different profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with normal controls. Through confirmation of different profile of BAs in T2DM, investigator will suggest modulation of specific bile acids as a new possible treatment target in patients with T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before hyperglycemia.
In addition, investigator will evaluate the association between each BA species and serum total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration in serum. Investigatr also evaluates the correlation between each BA species and metabolic profiles and oxidative stress marker to find possible roles of each BA component in glucose metabolism.
- Keywords
- type 2 diabetes, prediabetes, bile acids profile, GLP-1, FGF-19
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
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 |
|---|---|---|
| 1) Normal control | metabolically healthy with no obesity | |
| 2) prediabetes | defined in 'inclusion criteria' | |
| 3) type 2 diabetes | defined in 'inclusion criteria' |
What is being measured
The primary outcome is the main question the study is designed to answer.
bile acid profile
Bile acids profile to predict T2DM will be measured using high performance liquid chromatography-tandem mass spectrometry.
Measured: 8h fasting blood sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study start12 Sep 2015
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
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 Yonsei 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 362 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650830
- Sponsor's protocol ID
- 4-2015-0503
- Status last verified
- Jan 2019
- First submitted
- 6 Jan 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: no plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress
- ClinicalTrials.gov ID
- NCT02650830
- Acronym / sponsor ID
- 4-2015-0503
- Keywords
- type 2 diabetes, prediabetes, bile acids profile, GLP-1, FGF-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 362 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Sep 2015 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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.
"The goal of this work is to critically test the hypothesis that there exists a different profile of bile acids (BAs) in patient with type 2 diabetes mellitus (T2DM) compared with normal controls. Through confirmation of different profile of BAs in T2DM, investigator will suggest modulation of specific bile acids as a new possible treatment target in patients with T2DM. Investigator also expect the specific BAs signature will be used to screen T2DM before hyperglycemia.
In addition, investigator will evaluate the association between each BA species and serum total glucagon like peptide-1 (GLP-1) or fibroblast growth factor-19 (FGF-19) concentrations to determine if the specific BAs profile is related with total GLP-1 or FGF-19 concentration in serum. Investigatr also evaluates the correlation between each BA species and metabolic profiles and oxidative stress marker to find possible roles of each BA component in glucose metabolism.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1) Normal control | – | –metabolically healthy with no obesity |
| 2) prediabetes | – | –defined in 'inclusion criteria' |
| 3) type 2 diabetes | – | –defined in 'inclusion criteria' |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are recruited from either patients who visit out-patient clinics (Diabetes center in Severance hospital) or healthy volunteers.
Key inclusion criteria (3 listed)
- pre-diabetes 1. defined according to the ADA guideline (prediabetes definition) FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (IFG) or 2-h PG in the 75-g OGTT 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT) or A1C 5.7-6.4% (39-46 mmol/mol)
- type 2 diabetes 1. defined according to the ADA guideline (DM definition) FPG ≥126 mg/dL (7.0 mmol/L) or 2-h PG ≥200 mg/dL (11.1 mmol/L) in the 75-g OGTT or A1C ≥6.5% (48 mmol/mol) or In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose ≥200 mg/dL (11.1 mmol/L) or 2. taking any anti-diabetic medications
- Normal control 1. should not be included in other groups as above and 2. not taking any medication related to diabetes and dyslipidemia and 3. BMI <25kg/m2
Key exclusion criteria (4 listed)
- subjects who refused to agree with informed consents
- subjects with organ-transplantation
- pregnant women
- type 1 diabetes -
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
bile acid profile
Time frame: 8h fasting blood sample
Bile acids profile to predict T2DM will be measured using high performance liquid chromatography-tandem mass spectrometry.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: No. no plan to share data
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Prediabetes, run by Yonsei University at 1 site in South Korea.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jan 2019. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bile acid profile (time frame: 8h fasting blood sample). 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 22 Jan 2019.