Gut Microbiota in Obesity and Diabetes
Comparison of Gut Microbiota in Obese, Diabetic and Healthy Control Individuals
2 other identifiers
observational
81
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedJuly 2, 2014
July 1, 2014
8 months
July 1, 2014
July 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
The relationship between metabolic parameters and the gut microbiota composition
9 months
Study Arms (3)
Obesity
27 obese individuals (20 men and 7 women with mean BMI: 39.98±5.56 kg/m2)
Diabetes
26 patients with newly diagnosed type 2 diabetes (18 men and 8 women with mean BMI: 28.63±5.08 kg/m2)
Control
Healthy control subjects (22 men and 6 women with mean BMI: 23.02±1.70 kg/m2)
Interventions
Eligibility Criteria
Tertiary referral center
You may qualify if:
- Subjects with obesity or newly diagnosed type 2 diabetes
- years to 65 years of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Endocrinology and Metabolism, Gulhane School of Medicine
Ankara, 06180, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
July 1, 2014
First Posted
July 2, 2014
Study Start
January 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
July 2, 2014
Record last verified: 2014-07