Prevention of Progression of Prediabetes, Obesity and CV Risk

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Hemoglobin A1c Level (HBA1c) [Срок оценки: Baseline and 6 months]

Вторичные конечные точки (8)

• Body Mass Index (BMI) [Срок оценки: Baseline and 6 months]
• Percentage of Body Fat Composition [Срок оценки: Baseline and 6 months]
• Left Ventricular Function [Срок оценки: Baseline and 6 months]
• Measure of phosphocreatine k-value [Срок оценки: Baseline and 6 months]
• Measure of oxidative capacity [Срок оценки: Baseline and 6 months]
• Measure of intramyocellular lipids (IMCL) [Срок оценки: Baseline and 6 months]
• Measure of extramyocellular lipids (EMCL) [Срок оценки: Baseline and 6 months]
• Patient Reported Outcomes (PROMIS) [Срок оценки: Baseline and 6 months]

Критерии участия

Критерии включения

• 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:

• Not pregnant or breast-feeding
• Negative pregnancy test result at visit 1 (screening)
• 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
• Does not suffer from severe claustrophobia
• No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)

Критерии исключения

• Patients currently on one of the selected therapies
• Extended diagnoses with Type 2 Diabetes
• Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
• Known allergy/sensitivity to study drugs or their ingredients
• Major oncologic diagnosis in the last 5 years
• Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
• Inability or unwillingness of individual or legal guardian/representative to give written informed consent
• Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
• Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
• Heart transplant recipient or listed for a heart transplant
• Currently implanted left ventricular assist device
• Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
• Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
• 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
• Implanted cardioverter defibrillator within 3 months prior to screening
• Cardiac resynchronization therapy

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas Health Science Center at San Antonio — San Antonio

Идентификаторы

NCT: NCT06446531 · STUDY00000485 Pre-DM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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