Gut Microbiota in Obesity and Diabetes

July 1, 2014 updated by: Yalcin Basaran, Gulhane School of Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

81

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06180
        • Department of Endocrinology and Metabolism, Gulhane School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Tertiary referral center

Description

Inclusion Criteria:

  • Subjects with obesity or newly diagnosed type 2 diabetes
  • 18 years to 65 years of age

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obesity
27 obese individuals (20 men and 7 women with mean BMI: 39.98±5.56 kg/m2)
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)
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)
Other: Comparison of the gut microbiota composition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The relationship between metabolic parameters and the gut microbiota composition
Time Frame: 9 months
A multivariate linear regression analysis was performed in order to test associations between the gut microbiota composition and metabolic variables of participants
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulhane School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSM-2012/48
  • GSM-2012 (Other Identifier: Gulhane School of Medicine-2012)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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