Gut Microbiota in Obesity and Diabetes

Obesity Clinical Trial

Official title:

Comparison of Gut Microbiota in Obese, Diabetic and Healthy Control Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02180191
• Other study ID #: GSM-2012/48
• Secondary ID: GSM-2012
• Status: Completed
• Phase: N/A
• First received: July 1, 2014
• Last updated: July 1, 2014
• Start date: January 2013
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Gulhane School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical 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. Then, associations between analyzed gut microbial concentrations and clinical-biochemical blood parameters were assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity
• Type 2 Diabetes Mellitus

Intervention

Other:
• Comparison of the gut microbiota composition

Locations

Country	Name	City	State
Turkey	Department of Endocrinology and Metabolism, Gulhane School of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Gulhane School of Medicine

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	9 months	No
Secondary	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	9 months	No