ObesityNCT02180191
Gut Microbiota in Obesity and Diabetes
An observational study of Obesity and Type 2 Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
Trial summary
An altered gut microbiota composition has recently been linked to obesity and diabetes. The principal aim of this study was to investigate and compare the gut microbiota composition of obese, diabetic and control individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Comparison of the gut microbiota composition
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2013to Sep 2013
- 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: Tertiary referral center
Who may be able to join
- Subjects with obesity or newly diagnosed type 2 diabetes
- 18 years to 65 years of age
Who cannot join
- Any chronic disease (other than obesity and diabetes)
- Alcohol consumption/smoking
- Pregnancy/breastfeeding
- The use of antibiotics, pro-prebiotics within 3 months
- <18 years or >65 years
- History of intestinal surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Endocrinology and Metabolism, Gulhane School of Medicine
Ankara, 06180
About this study
Official title: Comparison of Gut Microbiota in Obese, Diabetic and Healthy Control Individuals
An altered gut microbiota composition has recently been linked to obesity and diabetes. The principal aim of this study was to investigate and compare the gut microbiota composition of obese, diabetic and control individuals. Then, associations between analyzed gut microbial concentrations and clinical-biochemical blood parameters were assessed.
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Being tested
- Comparison of the gut microbiota composition
- Keywords
- Gut microbiota
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of the gut microbiota compositionOther
| Study group | Role | What they receive |
|---|---|---|
| Obesity | 27 obese individuals (20 men and 7 women with mean BMI: 39.98±5.56 kg/m2) Receives: Other: Comparison of the gut microbiota composition | |
| Diabetes | 26 patients with newly diagnosed type 2 diabetes (18 men and 8 women with mean BMI: 28.63±5.08 kg/m2) Receives: Other: Comparison of the gut microbiota composition | |
| Control | Healthy control subjects (22 men and 6 women with mean BMI: 23.02±1.70 kg/m2) Receives: Other: Comparison of the gut microbiota composition |
What is being measured
The primary outcome is the main question the study is designed to answer.
The comparison of the gut microbiota composition
The gut microbiota composition of obese, diabetic and control individuals was analyzed by quantitative real-time PCR (qRT-PCR)
Measured: 9 months
Secondary outcomes (1)
The relationship between metabolic parameters and the gut microbiota composition
A multivariate linear regression analysis was performed in order to test associations between the gut microbiota composition and metabolic variables of participants
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2014 (estimated)
- Study startJan 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulhane School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yalcin Basaran, Gulhane School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02180191
- Sponsor's protocol ID
- GSM-2012/48
- Other IDs
- GSM-2012
- Status last verified
- Jul 2014
- First submitted
- 1 Jul 2014
- Last updated
- 2 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Gut Microbiota in Obese, Diabetic and Healthy Control Individuals
- ClinicalTrials.gov ID
- NCT02180191
- Acronym / sponsor ID
- GSM-2012/48
- Conditions
- Obesity, Type 2 Diabetes Mellitus
- Keywords
- Gut microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Gulhane School of MedicineUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Jul 2014 (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.
An altered gut microbiota composition has recently been linked to obesity and diabetes. The principal aim of this study was to investigate and compare the gut microbiota composition of obese, diabetic and control individuals. Then, associations between analyzed gut microbial concentrations and clinical-biochemical blood parameters were assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | Other: Comparison of the gut microbiota composition27 obese individuals (20 men and 7 women with mean BMI: 39.98±5.56 kg/m2) |
| Diabetes | – | Other: Comparison of the gut microbiota composition26 patients with newly diagnosed type 2 diabetes (18 men and 8 women with mean BMI: 28.63±5.08 kg/m2) |
| Control | – | Other: Comparison of the gut microbiota compositionHealthy control subjects (22 men and 6 women with mean BMI: 23.02±1.70 kg/m2) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary referral center
Key inclusion criteria (2 listed)
- Subjects with obesity or newly diagnosed type 2 diabetes
- 18 years to 65 years of age
Key exclusion criteria (6 listed)
- Any chronic disease (other than obesity and diabetes)
- Alcohol consumption/smoking
- Pregnancy/breastfeeding
- The use of antibiotics, pro-prebiotics within 3 months
- <18 years or >65 years
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 |
|---|---|---|
| Comparison of the gut microbiota composition | Other | Control, Diabetes, Obesity |
Primary outcome
The comparison of the gut microbiota composition
Time frame: 9 months
The gut microbiota composition of obese, diabetic and control individuals was analyzed by quantitative real-time PCR (qRT-PCR)
1 secondary outcome
The relationship between metabolic parameters and the gut microbiota composition
Time frame: 9 months
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 2 Jul 2014.
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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 Obesity and Type 2 Diabetes Mellitus, run by Gulhane School of Medicine at 1 site in Turkey (Türkiye).
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 6 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 2 Jul 2014. 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 Turkey (Türkiye). 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?
The comparison of the gut microbiota composition (time frame: 9 months). 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 2 Jul 2014.