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.
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
Show all 10Show fewer
- 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.
Show all 14Show fewer
- 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
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 group | Role | What they receive |
|---|---|---|
| Type 2 Diabetic | Type 2 diabetic individuals of Mexican descent. | |
| Non-diabetic Controls | Non-diabetic individuals of Mexican descent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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.
- First posted26 Oct 2020
- Study start14 Jan 2021
- Primary completion31 May 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelly Buffington, PhD, Principal investigator, University of Texas Medical Branch Galveston
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbial Determinants of Dementia Risk in Type 2 Diabetics of Mexican Descent
- ClinicalTrials.gov ID
- NCT04602650
- Acronym / sponsor ID
- 20-0201
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetic | – | –Type 2 diabetic individuals of Mexican descent. |
| Non-diabetic Controls | – | –Non-diabetic individuals of Mexican descent. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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).
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fecal Microbial Gene Sequencing
Time frame: Baseline
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.
3 secondary outcomes
Gastrointestinal health as measured by gastrointestinal symptom rating scale
Time frame: Baseline
Food Preference Questionnaire
Time frame: Baseline
Neurological History Questionnaire
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Derived from this study: PubMed 40969174Matz 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.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelly Buffington, PhD principal investigator
University of Texas Medical Branch Galveston
1 site in 1 country: see every site and its status.
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.