Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Hemoglobin A1c Level (HBA1c)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Placebo
Randomization will occur 1:1:1:1 to this placebo group
干预措施: Placebo (Drug)
SGLT2 inhibitor Group
Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group
干预措施: Jardiance 25Mg Tablet (Drug)
GLP-1 Receptor Agonist Group
Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group
干预措施: Rybelsus Tablet (Drug)
Metformin with SGLT2 Inhibitor Group
Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group
干预措施: Metformin (Drug)
Metformin with SGLT2 Inhibitor Group
Randomization will occur 1:1:1:1 to this metformin plus SGLT2 inhibitor group
干预措施: Actos (Drug)
结局指标
主要结局
Hemoglobin A1c Level (HBA1c)
时间窗: Baseline and 6 months
Percentage of glycated hemoglobin level in blood
次要结局
- Body Mass Index (BMI)(Baseline and 6 months)
- Percentage of Body Fat Composition(Baseline and 6 months)
- Left Ventricular Function(Baseline and 6 months)
- Measure of phosphocreatine k-value(Baseline and 6 months)
- Measure of oxidative capacity(Baseline and 6 months)
- Patient Reported Outcomes (PROMIS)(Baseline and 6 months)
- Measure of intramyocellular lipids (IMCL)(Baseline and 6 months)
- Measure of extramyocellular lipids (EMCL)(Baseline and 6 months)