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| Name | Class |
|---|---|
| Baptist Health Foundation of San Antonio | UNKNOWN |
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The investigators are studying how to help people with prediabetes (Pre-DM) and obesity. The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.
While taking part in this study, participants will be asked to attend approximately 16 visits with the researchers or study staff.
Study participants are assigned (single-blinded, only the study team will know the assigned group) to one of 4 study groups, receiving a 6-month treatment with Nutritional Consultation + either SGLT2 Inhibitor (Empagliflozin), Rybelsus (GLP1 Receptor Agonist), Metformin + Pioglitazone, or placebo. A placebo is an inactive, harmless substance that looks like the other study drugs. This study does not require overnight stays at the hospital in any of the study groups.
Duration of the Study will be about 6-7 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Randomization will occur 1:1:1:1 to this placebo group |
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| SGLT2 inhibitor Group | Experimental | Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group |
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| GLP-1 Receptor Agonist Group | Experimental | Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group |
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| Metformin with SGLT2 Inhibitor Group | Experimental | Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral tablet administered once daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1c Level (HBA1c) | Percentage of glycated hemoglobin level in blood | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) | Measure of body fat based on height and weight that applies to adult men and women | Baseline and 6 months |
| Percentage of Body Fat Composition | Measurement of body fat using a DEXA scan |
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Inclusion Criteria:
Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the last 6 months.
Age ≥ 18 years old
Body Mass Index (BMI)=25-40 kg/m2
Glycated Hemoglobin (HbA1c) = 5.7-6.4%
Blood Pressure (BP) <160/100
Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
Body weight must be stable (±5 pounds) over the last 3 months.
Oral diuretics, if prescribed to the patient according to local guidelines and discretion of the investigator, should be stable for at least 1 week prior to randomization.
Hispanic ethic group
Willing to adhere to medication regimen for up to 6 months.
Male or female, if female, met these criteria:
Does not suffer from severe claustrophobia
No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Solis-Herrera, MD | Contact | 210-567-4900 | solisherrera@uthscsa.edu | |
| Francisca Acosta, PhD | Contact | acostafm@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Carolina Solis-Herrera, MD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
The Institution or respective designees may present or publish the results of a scientific investigation involving this Study in accordance with International Committee of Medical Journal Editors (ICMJE). The Sponsor Investigator, funding agency, or PI initiating the study will collaborate to determine who has publication rights for authorship upon review and approval of proposed manuscripts.
At the time of publication in a peer review journal
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D001835 | Body Weight |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| C570240 | empagliflozin |
| D013607 | Tablets |
| D008687 | Metformin |
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001645 | Biguanides |
| D006146 | Guanidines |
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Single-blind Randomized, placebo-controlled trial.
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This will be single blind study, given all treatment arms being pills, once subjects are randomized, they will not be told which mediation they are taking, and treatment will be dispensed in unmarked bottles at each timepoint.
| Rybelsus Tablet | Drug | Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose. |
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| Jardiance 25Mg Tablet | Drug | Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily |
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| Metformin | Drug | Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets) |
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| Actos | Drug | Oral tablet dosed at 15mg once daily |
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|
| Baseline and 6 months |
| Left Ventricular Function | Cardiac function is measured by left-ventricular function measured using cardiac MRI and expressed as a percentage | Baseline and 6 months |
| Measure of phosphocreatine k-value | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS | Baseline and 6 months |
| Measure of oxidative capacity | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS | Baseline and 6 months |
| Measure of intramyocellular lipids (IMCL) | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS | Baseline and 6 months |
| Measure of extramyocellular lipids (EMCL) | A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS | Baseline and 6 months |
| Patient Reported Outcomes (PROMIS) | A survey used to assess physical function. Subjects will rank 20 questions from a scale of 1 - 5, with 5 being the highest physical function and 1 being the lowest. The score will be added up, and the Raw score will be converted to T-Score using the PROMIS Adult v2.0 Physical Function 20a Short Form Conversion Table. The range of T-scores is 12.1-62.5. A higher score indicates higher physical function. | Baseline and 6 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000578 |
| Amidines |
| D009930 | Organic Chemicals |
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |