AzTrials
AzTrials

DiabetesNCT04602650

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

An observational study of Diabetes, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes
How many people
12 participants
Where
1 siteUnited States
Study dates
14 Jan 2021to 31 Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

  • Type 2 Diabetic Inclusion Criteria
  • 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.
  • Non-Diabetic Control Inclusion Criteria
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  • 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.

Who cannot join

  • Type 2 Diabetic Exclusion Criteria
  • 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.
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  • Other medical condition or medication administration deemed exclusionary by the study investigators.
  • Non-Diabetic Control Exclusion Criteria
  • 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.
  • Other medical condition or medication administration deemed exclusionary by the study investigators.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Texas Medical Branch

    Galveston, Texas, 77555

Other trials in United States

About this study

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.

Read the detailed description

Type 2 diabetes (T2D) as a common antecedent of pathological neurodegeneration and dementia, including Alzheimer's Disease (AD); yet the mechanistic link between metabolic and neurodegenerative disorders remains unresolved. 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 lay critical groundwork toward addressing the investigators' overarching hypothesis that dysbiosis of the gut microbiome in type 2 diabetic individuals of Mexican descent living in South Texas is causally related to the increased prevalence of comorbid, early onset AD in this population. In this study, the investigators will perform state-of-the-art metagenomic 16S ribosomal RNA (rNRA) gene sequencing and bioinformatic analysis on fecal samples collected from type 2 diabetic and non-diabetic control individuals of Mexican descent to test the working hypothesis that the community structure of the gut microbiome of individuals of Mexican descent with T2D is significantly altered compared to that of nondiabetics within the same population. To the investigators' knowledge, this multidisciplinary pilot study will be the first to investigate the gut microbial community structure of type 2 diabetic versus that of nondiabetic individuals of Mexican descent. Furthermore, it has the potential to provide mechanistic insight into how T2D predisposes individuals to the neuropathology and cognitive impairment characteristic of AD and to identify a novel class of interventions that target the host gut microbiome for the prevention of early onset AD in a predisposed population, as well as the population at large.

Human subjects will be recruited through the University of Texas Medical Branch at Galveston (UTMB) Endocrinology and pre-screened to confirm that the potential participants meet established inclusion and exclusion criteria as either T2D or nondiabetic controls, as defined in the UTMB human subjects protocol associated with this project. Pre-screened participants that meet the defined criteria will be invited to attend an appointment with a study coordinator held at the UTMB Clinical Research Center. Consented and enrolled study participants will be asked to complete medical history, dietary preference, and gastrointestinal function questionnaires and instructed as to how to use the provided OMNIgene-GUT RNA (OMR)-200 fecal sample collection kit (DNA GenoTek). Participants will submit the collected fecal sample via shipment of a pre-paid and labeled shipping envelope. Samples will be deidentified and stored at -80oC in the Buffington Lab prior to shipment to the Baylor College of Medicine Center for Metagenomic and Microbiome Research (CMMR) for metagenomic 16S rRNA gene sequencing. Briefly, bacterial genomic DNA will be extracted using the MagAttract PowerSoil Kit (Qiagen) and the 16S ribosomal DNA (rDNA) V4 region will be amplified by polymerase chain reaction (PCR) and sequenced on the MiSeq platform (Illumina). 16S rRNA gene read pairs will be demultiplexed based on unique molecular barcodes added to primers used for amplification and reads will be merged using USEARCH. 16S rRNA gene sequences will be clustered into Operational Taxonomic Units (OTUs) using the UPARSE algorithm and mapped to an optimized version of the SILVA database to determine taxonomies. The investigators will then use a custom script developed by the CMMR to construct a rarefied OTU table for downstream analyses of alpha-diversity, beta-diversity, and phylogenetic trends to identify any changes in community structure between type 2 diabetic and non-diabetic individuals of Mexican descent enrolled in the study.

Conditions
Diabetes
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04602650
Study groupRoleWhat they receive
Type 2 DiabeticType 2 diabetic individuals of Mexican descent.
Non-diabetic ControlsNon-diabetic individuals of Mexican descent.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (3)
  1. Gastrointestinal health as measured by gastrointestinal symptom rating scale

    The Gastrointestinal Symptom Rating Scale (GSRS) is a specific 15-item questionnaire. Subjects are asked to numerically score their subjective symptoms on a scale of 1-7 (1 = no discomfort at all; 7 = very severe discomfort). The sum of the scores for all 15 items is regarded as the GSRS total score. Total scores range from 15 (best outcome) to 105 (worst outcome). GSRS will be measured at baseline.

    Measured: Baseline

  2. Food Preference Questionnaire

    The Food Preference Questionnaire (FPQ) is a specific 3-item questionnaire. Subjects are asked to first indicate whether they identify as vegan, vegetarian, pescetarian, or none of the above. They are then asked whether they have any food allergies to eleven common food allergies and have the option to specify a food allergy not listed under "Other." Finally, the subject is asked to indicate preference (ranging from "dislike a lot" to "like a lot") for 59 specific food items in a table. FPQ will be acquired at baseline.

    [Modified from "Food Preference Questionnaire for Adolescents and Adults," University College London, Institute of Epidemiology and Health Care, Research Department of Behavioural Science and Health.]

    Measured: Baseline

  3. Neurological History Questionnaire

    The Neurological History Questionnaire (NHQ) is a specific 2-item questionnaire. First, subjects are asked to indicate whether they have ever been diagnosed one of ten common neurological disorders. In the second question, subjects are asked to indicate whether they have experienced either of the following neurological events: (1) ischemic stroke or (2) mild traumatic brain injury.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2020
  2. Study start14 Jan 2021
  3. Primary completion31 May 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04602650
Sponsor's protocol ID
20-0201
Status last verified
Feb 2023
First submitted
20 Oct 2020
Last updated
15 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We do not plan to make individual participant data (IPD) available to other researchers.

Publications

  • 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;3:1456642. doi: 10.3389/frmbi.2024.1456642. Epub 2024 Dec 3.

    PubMed 40969174

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by The University of Texas Medical Branch, Galveston at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fecal Microbial Gene Sequencing (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04602650, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

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