Prevention of Progression of Prediabetes, Obesity and CV Risk

Cardiovascular Diseases Clinical Trial

— Pre-DM  

Official title:

Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446531
• Other study ID #: STUDY00000485 Pre-DM
• Status: Recruiting
• Phase: Phase 1
• Start date: July 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Carolina Solis-Herrera, MD
• Phone: 210-567-4900
• Email: solisherrera[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Age = 18 years old

3. Body Mass Index (BMI)=25-40 kg/m2

4. Glycated Hemoglobin (HbA1c) = 5.7-6.4%

5. Blood Pressure (BP) <160/100

6. Estimated Glomerular Filtration Rate (eGFR) =30 ml/min•1.73m2

7. Body weight must be stable (±5 pounds) over the last 3 months.

8. 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.

9. Hispanic ethic group

10. Willing to adhere to medication regimen for up to 6 months.

11. Male or female, if female, met these criteria:

1. Not pregnant or breast-feeding

2. Negative pregnancy test result at visit 1 (screening)

3. During the entire study, women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or pills, or a vasectomized partner prior to receiving the first dose of study medication

12. Does not suffer from severe claustrophobia

13. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Exclusion Criteria:

1. Patients currently on one of the selected therapies

2. Extended diagnoses with Type 2 Diabetes

3. Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception

4. Known allergy/sensitivity to study drugs or their ingredients

5. Major oncologic diagnosis in the last 5 years

6. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

7. Inability or unwillingness of individual or legal guardian/representative to give written informed consent

8. Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study

9. Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days

10. Heart transplant recipient or listed for a heart transplant

11. Currently implanted left ventricular assist device

12. Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction

13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period

14. Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization

15. Implanted cardioverter defibrillator within 3 months prior to screening

16. Cardiac resynchronization therapy

Related Conditions & MeSH terms

• Body Weight
• Cardiovascular Diseases
• Disease Progression
• Pre-Diabetes
• Prediabetic State
• Weight, Body

Intervention

Drug:
• Placebo
Oral tablet administered once daily
• Rybelsus Tablet
Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.
• Jardiance 25Mg Tablet
Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily
• Metformin
Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)
• Actos
Oral tablet dosed at 15mg once daily

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Baptist Health Foundation of San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1c Level (HBA1c)	Percentage of glycated hemoglobin level in blood	Baseline and 6 months
Secondary	Body Mass Index (BMI)	Measure of body fat based on height and weight that applies to adult men and women	Baseline and 6 months
Secondary	Percentage of Body Fat Composition	Measurement of body fat using a DEXA scan	Baseline and 6 months
Secondary	Left Ventricular Function	Cardiac function is measured by left-ventricular function measured using cardiac MRI and expressed as a percentage	Baseline and 6 months
Secondary	Measure of phosphocreatine k-value	A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS	Baseline and 6 months
Secondary	Measure of oxidative capacity	A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS	Baseline and 6 months
Secondary	Measure of intramyocellular lipids (IMCL)	A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS	Baseline and 6 months
Secondary	Measure of extramyocellular lipids (EMCL)	A skeletal muscle bioenergetic measurement using skeletal muscle MRI/MRS	Baseline and 6 months
Secondary	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