Gut Microbiota in Obesity and Diabetes

Completed

• Conditions: Type 2 Diabetes Mellitus; Obesity
• Interventions: Other: Comparison of the gut microbiota composition

• Registration Number: NCT02180191
• Lead Sponsor: Gulhane School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Status Verified: 2014-07
• Study First Submitted: 2014-07-01
• Study First Submitted QC: 2014-07-01
• Last Update Submitted: 2014-07-01
• Study First Posted: 2014-07-02
• Last Update Posted: 2014-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obesity	Comparison of the gut microbiota composition	27 obese individuals (20 men and 7 women with mean BMI: 39.98±5.56 kg/m2)
Diabetes	Comparison of the gut microbiota composition	26 patients with newly diagnosed type 2 diabetes (18 men and 8 women with mean BMI: 28.63±5.08 kg/m2)
Control	Comparison of the gut microbiota composition	Healthy control subjects (22 men and 6 women with mean BMI: 23.02±1.70 kg/m2)

Primary Outcome Measures

Name	Time	Method
The comparison of the gut microbiota composition	9 months	The gut microbiota composition of obese, diabetic and control individuals was analyzed by quantitative real-time PCR (qRT-PCR)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Endocrinology and Metabolism, Gulhane School of Medicine; 🇹🇷 Ankara, Turkey