PreDiabetesPhase 4NCT05119179
Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes
A Phase 4 study testing Semaglutide in people with PreDiabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This project uses both transcriptomic- and genomic-level data to identify mechanisms of individual responses to glucagon-like peptide-1 (GLP-1) in Mexican-Americans with prediabetes. The GLP-1 hormone is essential for glucose reduction, weight loss, cardiovascular risk reduction, and renal protection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2021to 31 Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, ages 18 years and older
- Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or a hemoglobin A1C ranging from 5.7% to 6.4%
- High risk for progression to diabetes: defined as having at least one of the two following additional factors: Obesity (BMI ≥ 30 kg/m2) and/or metabolically unhealthy status. "Metabolically unhealthy status" is defined as at least two of the following: elevated blood pressure (SBP ≥ 130 mmHg and/or DBP ≥ 85 mmHg), elevated triglycerides ≥ 150 mg/dL, low HDL cholesterol (males < 40 mg/dL; females < 50 mg/dL), and elevated fasting glucose ≥ 100 mg/dL (Wu S et al., 2017).
- Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, hormonal contraception, intrauterine contraception, or surgical sterilization) for the duration of the study.
- Patients must have the following laboratory values: Hematocrit ≥ 34 vol%, estimated glomerular filtration rate ≥ 60 mL/min per 1.73 m2, AST (SGOT) < 2.5 times ULN, ALT (SGPT) < 2.5 times ULN, alkaline phosphatase < 2.5 times ULN
Who cannot join
- History of Type 1 or Type 2 diabetes mellitus
- Pregnant or breastfeeding women
- Medications: metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, insulin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, and/or corticosteroids over the last 3 months.
- Active malignancy
- History of clinically significant cardiac, hepatic, pancreatic or renal disease.
- History of any serious hypersensitivity reaction to the study medication (or any other incretin mimetic)
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- Prisoners or subjects who are involuntarily incarcerated
- Prior history of pancreatitis, medullary thyroid cancer, or multiple endocrine neoplasia type 2 (MEN 2)
- Family history of medullary thyroid cancer (a rare form of thyroid cancer) or MEN2. However, as many individuals may not be aware of the specific type of thyroid cancer, will also exclude any family history of thyroid cancer or MEN2.
- Hospitalization for COVID-19 in last 3 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UTHealth Clinical Research Unit (CRU) at UT Brownsville
Brownsville, Texas, 78520
Norma Perez-Olazaran, 956-755-0695, Norma.P.PerezOlazaran@uth.tmc.edu
Rocio Uribe, (956) 882-5165, Rocio.D.Uribe@uth.tmc.edu
About this study
This project uses both transcriptomic- and genomic-level data to identify mechanisms of individual responses to glucagon-like peptide-1 (GLP-1) in Mexican-Americans with prediabetes. The GLP-1 hormone is essential for glucose reduction, weight loss, cardiovascular risk reduction, and renal protection. Newly discovered mechanisms will illuminate causal links between disease genotype and phenotype, which may ultimately guide personalized therapeutic approaches for type 2 diabetes, prediabetes, obesity, cardiovascular disease, renal disease, and other related diseases.
Read the detailed description
This clinical trial will uncover new mechanisms of inter-individual responses to endogenous and exogenous glucagon-like peptide-1 (GLP-1) in Hispanics/Latinos (H/Ls) with prediabetes. The results move the management of prediabetes, type 2 diabetes mellitus (T2DM), and relevant metabolic diseases to a more individualized approach in an understudied and at-risk population. Few options exist for prediabetes treatment, and the current pharmaceutical management of T2DM does not predict drug treatment failures, nor differences in individual treatment responses and adverse effects. A precise, genetics-based approach will provide superior therapeutic management for patients. GLP-1-based therapies reduce blood glucose, promote weight loss, decrease cardiovascular events, and improve renal function. Prior genetic studies, most done in Caucasians, identified associations between genetic variants and decreased GLP-1-induced insulin secretion, in an effort to guide individualized treatment. However, these associations do not provide a clear mechanistic relationship between genotype and phenotype. Transcriptomic analyses will uncover many of these mechanisms. Here, we propose to 1) test the association of single nucleotide polymorphisms (SNPs) that regulate expression (eQTLs) of 11 candidate genes in a range of relevant metabolic tissues with differential GLP-1 response, 2) perform RNA sequencing before and after treatment to identify eQTLs in blood that predict response to GLP-1 therapy and develop risk-based prediction models in H/Ls, and 3) determine the effects of genetic regulation of candidate genes and newly discovered eQTLs phenome-wide in a large existing biobank, BioVU. For aims 1 and 2, responses will be measured in 300 study subjects with prediabetes recruited from an established Mexican-American cohort via the oral minimal model method, before and after GLP-1 therapy, quantifying GLP-1 hormone efficacy and GLP-1-induced pancreatic beta cell insulin release and peripheral insulin sensitivity. Procedures include serial measurements of plasma glucose, insulin, C-peptide, and GLP-1, and peripheral blood collection for RNA sequencing. Our central hypotheses are: (1) metabolic tissue-based eQTLs of GLP-1-associated genes will be associated with physiological response to endogenous and exogenous GLP-1,(2) identification of eQTLs associated with GLP-1 treatment-induced changes in whole blood will identify new gene targets, and (3) this data will lead to the creation of eQTL-based prediction models for related diseases. The study is innovative because it uses a novel combination of eQTL analysis and oral minimal model to assess GLP-1 response, examines a population highly underrepresented in pharmacogenomic studies, and utilizes novel statistical methods and applications to study gene expression. The significance of this newly acquired mechanistic information will ultimately guide precision therapeutic regimens for diabetes prevention and treatment, weight loss, cardiovascular risk reduction, and related metabolic complications in an understudied population.
- Conditions
- PreDiabetes
- Being tested
- Semaglutide
- Keywords
- prediabetes, Mexican-American, GLP-1, pharmacogenetics, expression quantitative trait loci
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Ozempic
Glucagon-like Peptide 1 Receptor Agonist
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Semaglutide 0.25 mg subcutaneously weekly for 4 weeks, followed by semaglutide 0.5 mg subcutaneously weekly for 8 weeks. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in beta cell responsivity
A rate which measures the ability of beta cells to secrete insulin
Measured: 12 weeks
Insulin Sensitivity
Measurement of the efficacy of insulin action at peripheral tissues
Measured: 12 weeks
Disposition Index
Product of beta cell responsivity and insulin sensitivity (see above)
Measured: 12 weeks
GLP-1-Induced Potentiation
Measurement of GLP-1 (glucagon-like peptide 1) hormonal efficacy in relationship to postprandial insulin secretion
Measured: 12 weeks
Mean change in GLP-1 Area Under the Curve (AUC)
Comparison of GLP-1 AUC measurements before and after drug intervention
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for TCF7L2
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for KCNQ1
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for WFS1
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for THADA
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for CNR1
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for CTRB1
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for CTRB2
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for GLP1R
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for CHST3
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for MTNR1B
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Gene expression changes for minor variants of eQTLs for SORCS1
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Measured: 12 weeks
Previously unidentified cis-eQTLs associated with change in gene expression due to GLP-1 challenge
Study has statistical power to detect previously unidentified eQTLs
Measured: 12 weeks
Secondary outcomes (6)
Mean change in glucose Area Under the Curve (AUC)
Comparison of glucose AUC measurements before and after drug intervention
Measured: 12 weeks
Mean change in C-peptide Area Under the Curve (AUC)
Comparison of C-peptide AUC measurements before and after drug intervention
Measured: 12 weeks
Change in hemoglobin A1C
Change in hemoglobin A1C (measured once on each study day) before and after intervention
Measured: 12 weeks
Mean change in insulin Area Under the Curve (AUC)
Comparison of insulin AUC measurements before and after drug intervention
Measured: 12 weeks
Creation of eQTL-based disease prediction models
Create and apply eQTL-based prediction models to investigate the clinical consequences of variable GLP-1- induced gene expression changes (identified as above) in large electronic health records (EHRs), and use these models to predict disease risk phenome-wide.
Measured: 5 years
Polygenic prediction model for GLP-1 therapy-associated outcomes
Creation of Polygenic prediction model using above data
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start22 Nov 2021
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, before and after clinical trial
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Absalon D Gutierrez, The University of Texas Health Science Center, Houston
- Investigators
- Absalon D Gutierrez, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05119179
- Sponsor's protocol ID
- HSC-MS-21-0297
- Other IDs
- 5R01DK127084
- Status last verified
- Mar 2026
- First submitted
- 5 Aug 2021
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes
- ClinicalTrials.gov ID
- NCT05119179
- Acronym / sponsor ID
- HSC-MS-21-0297
- Conditions
- PreDiabetes
- Keywords
- prediabetes, Mexican-American, GLP-1, pharmacogenetics, expression quantitative trait loci
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 15 Nov 2021 (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.
This project uses both transcriptomic- and genomic-level data to identify mechanisms of individual responses to glucagon-like peptide-1 (GLP-1) in Mexican-Americans with prediabetes. The GLP-1 hormone is essential for glucose reduction, weight loss, cardiovascular risk reduction, and renal protection. Newly discovered mechanisms will illuminate causal links between disease genotype and phenotype, which may ultimately guide personalized therapeutic approaches for type 2 diabetes, prediabetes, obesity, cardiovascular disease, renal disease, and other related diseases.
Detailed description
This clinical trial will uncover new mechanisms of inter-individual responses to endogenous and exogenous glucagon-like peptide-1 (GLP-1) in Hispanics/Latinos (H/Ls) with prediabetes. The results move the management of prediabetes, type 2 diabetes mellitus (T2DM), and relevant metabolic diseases to a more individualized approach in an understudied and at-risk population. Few options exist for prediabetes treatment, and the current pharmaceutical management of T2DM does not predict drug treatment failures, nor differences in individual treatment responses and adverse effects. A precise, genetics-based approach will provide superior therapeutic management for patients. GLP-1-based therapies reduce blood glucose, promote weight loss, decrease cardiovascular events, and improve renal function. Prior genetic studies, most done in Caucasians, identified associations between genetic variants and decreased GLP-1-induced insulin secretion, in an effort to guide individualized treatment. However, these associations do not provide a clear mechanistic relationship between genotype and phenotype. Transcriptomic analyses will uncover many of these mechanisms. Here, we propose to 1) test the association of single nucleotide polymorphisms (SNPs) that regulate expression (eQTLs) of 11 candidate genes in a range of relevant metabolic tissues with differential GLP-1 response, 2) perform RNA sequencing before and after treatment to identify eQTLs in blood that predict response to GLP-1 therapy and develop risk-based prediction models in H/Ls, and 3) determine the effects of genetic regulation of candidate genes and newly discovered eQTLs phenome-wide in a large existing biobank, BioVU. For aims 1 and 2, responses will be measured in 300 study subjects with prediabetes recruited from an established Mexican-American cohort via the oral minimal model method, before and after GLP-1 therapy, quantifying GLP-1 hormone efficacy and GLP-1-induced pancreatic beta cell insulin release and peripheral insulin sensitivity. Procedures include serial measurements of plasma glucose, insulin, C-peptide, and GLP-1, and peripheral blood collection for RNA sequencing. Our central hypotheses are: (1) metabolic tissue-based eQTLs of GLP-1-associated genes will be associated with physiological response to endogenous and exogenous GLP-1,(2) identification of eQTLs associated with GLP-1 treatment-induced changes in whole blood will identify new gene targets, and (3) this data will lead to the creation of eQTL-based prediction models for related diseases. The study is innovative because it uses a novel combination of eQTL analysis and oral minimal model to assess GLP-1 response, examines a population highly underrepresented in pharmacogenomic studies, and utilizes novel statistical methods and applications to study gene expression. The significance of this newly acquired mechanistic information will ultimately guide precision therapeutic regimens for diabetes prevention and treatment, weight loss, cardiovascular risk reduction, and related metabolic complications in an understudied population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, before and after clinical trial
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: SemaglutideSemaglutide 0.25 mg subcutaneously weekly for 4 weeks, followed by semaglutide 0.5 mg subcutaneously weekly for 8 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, ages 18 years and older
- Diagnosis of Prediabetes - defined as either impaired fasting glucose (fasting glucose of 100-125 mg/dL), impaired glucose tolerance (2-hour postprandial blood glucose of 140-199 mg/dL after 75-gram oral glucose challenge), and/or a hemoglobin A1C ranging from 5.7% to 6.4%
- High risk for progression to diabetes: defined as having at least one of the two following additional factors: Obesity (BMI ≥ 30 kg/m2) and/or metabolically unhealthy status. "Metabolically unhealthy status" is defined as at least two of the following: elevated blood pressure (SBP ≥ 130 mmHg and/or DBP ≥ 85 mmHg), elevated triglycerides ≥ 150 mg/dL, low HDL cholesterol (males < 40 mg/dL; females < 50 mg/dL), and elevated fasting glucose ≥ 100 mg/dL (Wu S et al., 2017).
- Women of childbearing age must agree to use an acceptable method of pregnancy prevention (barrier methods, abstinence, hormonal contraception, intrauterine contraception, or surgical sterilization) for the duration of the study.
- Patients must have the following laboratory values: Hematocrit ≥ 34 vol%, estimated glomerular filtration rate ≥ 60 mL/min per 1.73 m2, AST (SGOT) < 2.5 times ULN, ALT (SGPT) < 2.5 times ULN, alkaline phosphatase < 2.5 times ULN
Key exclusion criteria (10 listed)
- History of Type 1 or Type 2 diabetes mellitus
- Pregnant or breastfeeding women
- Medications: metformin, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT-2 inhibitors, thiazolidinediones, insulin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, and/or corticosteroids over the last 3 months.
- Active malignancy
- History of clinically significant cardiac, hepatic, pancreatic or renal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: OzempicGlucagon-like Peptide 1 Receptor Agonist | Drug | Semaglutide |
Primary outcome
Mean change in beta cell responsivity
Time frame: 12 weeks
A rate which measures the ability of beta cells to secrete insulin
Insulin Sensitivity
Time frame: 12 weeks
Measurement of the efficacy of insulin action at peripheral tissues
Disposition Index
Time frame: 12 weeks
Product of beta cell responsivity and insulin sensitivity (see above)
GLP-1-Induced Potentiation
Time frame: 12 weeks
Measurement of GLP-1 (glucagon-like peptide 1) hormonal efficacy in relationship to postprandial insulin secretion
Mean change in GLP-1 Area Under the Curve (AUC)
Time frame: 12 weeks
Comparison of GLP-1 AUC measurements before and after drug intervention
Gene expression changes for minor variants of eQTLs for TCF7L2
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for KCNQ1
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for WFS1
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for THADA
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for CNR1
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for CTRB1
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for CTRB2
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for GLP1R
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for CHST3
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for MTNR1B
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Gene expression changes for minor variants of eQTLs for SORCS1
Time frame: 12 weeks
eQTLs (expresion quantitative trait loci) are genes which affect the mRNA expression of another target gene.
Previously unidentified cis-eQTLs associated with change in gene expression due to GLP-1 challenge
Time frame: 12 weeks
Study has statistical power to detect previously unidentified eQTLs
6 secondary outcomes
Mean change in glucose Area Under the Curve (AUC)
Time frame: 12 weeks
Mean change in C-peptide Area Under the Curve (AUC)
Time frame: 12 weeks
Change in hemoglobin A1C
Time frame: 12 weeks
Mean change in insulin Area Under the Curve (AUC)
Time frame: 12 weeks
Creation of eQTL-based disease prediction models
Time frame: 5 years
Polygenic prediction model for GLP-1 therapy-associated outcomes
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Absalon D Gutierrez, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide in people with PreDiabetes, run by The University of Texas Health Science Center, Houston 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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Mar 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norma Perez-Olazaran ((956) 755-0695, Norma.P.PerezOlazaran@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in beta cell responsivity (time frame: 12 weeks). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.