Microbial Determinants of Dementia Risk in Type 2 Diabetics of Mexican Descent

NCT04602650 | Completed

• 1 other identifier: 20-0201
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Type 2 diabetes (T2D) predisposes individuals to neurodegeneration and dementia, including Alzheimer's Disease (AD); yet the link between metabolic and neurodegenerative disorders remains unknown. Here, the investigators will study a well-defined human population with increased prevalence and early onset of both T2D and AD, individuals of Mexican descent living in South Texas. The study will begin to explore the possibility that disruption of the structure of the bacterial community residing in the gut in type 2 diabetic individuals of Mexican descent living in South Texas is directly related to the increased prevalence of early onset AD in this population. In this study, the investigators will perform gene sequencing on DNA isolated from fecal samples to identify and compare the populations of bacteria living in individuals with T2D versus non-diabetic controls. The investigators will analyze the findings to determine if the community structure of the gut microbiome of individuals of Mexican descent with T2D is significantly altered compared to that of non-diabetics within the same population. The investigators' findings could lead to the identification of early indicators of dementia onset as well as novel therapies for treating metabolic and neurodegenerative diseases.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

• Fecal Microbial Gene Sequencing

  Metagenomic 16S ribosomal RNA (rRNA) gene sequencing will be performed on subject samples to determine the presence and measure the relative abundance of operational taxonomic units representative of bacterial genera, species, and strains present in the fecal sample.

  Baseline

Secondary Outcomes (3)

• Gastrointestinal health as measured by gastrointestinal symptom rating scale

  Baseline

• Food Preference Questionnaire

  Baseline

• Neurological History Questionnaire

  Baseline

Study Arms (2)

Type 2 Diabetic

Type 2 diabetic individuals of Mexican descent.

Non-diabetic Controls

Non-diabetic individuals of Mexican descent.

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will study subjects of Mexican descent living in Texas (aged 50-70 years) with a history of type 2 diabetes (T2D) (n=50, anticipated) and non-diabetic controls (aged 50 - 70 years) (n=50, anticipated).

You may qualify if:

• Male or female with a diagnosis of type 2 diabetes.
• Ages 50 to 70 years.
• Mexican descent living in Texas.
• Participant is willing and able to give informed consent for participation in the study.
• Male or female without history of type 2 diabetes.
• Ages 50 to 70 years.
• Mexican descent living in Texas.
• Participant is willing and able to give informed consent for participation in the study.

You may not qualify if:

• Hypertension that is not controlled by greater than 2 medications.
• Chronic kidney disease, CKD greater than 3.
• History of coronary bypass or stint placement.
• Current pregnancy.
• Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.
• Hypertension that is not controlled by greater than 2 medications.
• Chronic kidney disease, CKD greater than 3.
• History of coronary bypass or stint placement.
• Current pregnancy.
• Subjects with a history of inflammatory bowel disease, Celiac disease or active diverticular disease.

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

• Matz LM, Shah NS, Porterfield L, Stuyck OM, Jochum MD, Kayed R, Taglialatela G, Urban RJ, Buffington SA. Gut pathobiont enrichment observed in a population predisposed to dementia, type 2 diabetics of Mexican descent living in South Texas. Front Microbiomes. 2024;3:10.3389/frmbi.2024.1456642. doi: 10.3389/frmbi.2024.1456642. Epub 2024 Dec 3.

  PMID: 40969174 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Fecal bacterial DNA specimens will be retained.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Shelly Buffington, PhD

  University of Texas Medical Branch Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 26, 2020
• Study Start: January 14, 2021
• Primary Completion: May 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)