Identification of Gut Microbiome and Metabolome Biomarkers in Diabetes

H
Heba Ismail

Primary Investigator

Enrolling By Invitation
1 years - 75 years
All
Phase N/A
100 participants needed
4 Locations

Brief description of study

What is the purpose of this study?

The purpose of this study is to evaluate the gut microbiome and circulating microbial metabolites of children and adults with prediabetes and diabetes so we can compare the differences across different stages of diabetes but also across different forms of diabetes and different age groups.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants will be identified by review of medical records and our diabetes registry database. We will then contact them by phone as well as in clinic or during their hospital stay to gauge their interest. Pediatric subjects will primarily be recruited from the Riley Pediatric Diabetes Team's patient population of type-1 diabetics during clinic visits or upon diagnosis and inpatient records. Recruitment will also occur at Diabetes clinics at Methodist Hospital. The onset of T1D in adults tends to be more gradual and some individuals may be first mis-identified as having Type 2 diabetes. However, we may have the opportunity to collect a blood or stool sample from an adult with T1D who is hospitalized or being seen in an outpatient Endocrinology clinic. Moreover, our diabetes team also has contact with adults with new onset T1D who self-refer for evaluation for other clinical research studies.

Detailed description of study

What will happen during the study?

  • Collection and biobanking of stool and blood from subjects with T1D, T2D, genetic forms of diabetes and prediabetes.
  • Collection and biobanking of stool and blood from subjects with recently diagnosed T1D or T2D.
  • Subjects will collect stool samples at home and complete a diet recall. They will also have their blood drawn.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Prediabetes, Type 1 Diabetes, T1D, Type 2 Diabetes, T2D, Riley
  • Age: 1 years - 75 years
  • Gender: All

Inclusion Criteria

•    Able to provide informed consent/assent as appropriate 
•    Age 1-75 yrs.
•    Type 1 diabetes, defined by lean phenotype, or lean phenotype with evidence of autoimmune diabetes at any age.
•    Recent T1D diagnosis (within 2 weeks).  
•    Age 1-75 years of age
•    Type 2 diabetes, defined by typical obesity-associated DM with age of onset over 20, without evidence of rare variant forms
•    Recognized rare variant forms of diabetes such as; antibody negative, ketone positive (aka Flatbush) diabetes, and  maturity onset diabetes of youth (MODY).In situations where the diagnosis is known, this will be included in the Repository record.
•    Enrolled in a diabetes research study


Exclusion Criteria
•    Any condition that, in the investigator’s opinion, may compromise study participation or may confound the interpretation of the study results.
•    Psychiatric impairment or current use of anti-psychotic medication
•    History of recurrent infections
•    History of on-going infections or antibiotic treatment within the past 4-6 weeks
•    History of immune compromise
•    Steroid intake (systemic) within the past 4 weeks.

Updated on 20 Mar 2025. Study ID: PENDO-IIR-GUT-MICROBIOME, 25593
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