Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity

Ki nem vehet részt

• Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB)
• Hypo- or hyper-thyroid disease (TSH >5.0, or <0.4 MIU/L) that is controlled for less than one year or someone currently taking thyroid hormone replacement
• Individuals that have been on a very low-calorie diet (<800 kcal/d), self-reported weight loss >5% in the preceding six months, or those taking weight loss medications
• Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components)
• Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment
• Moderate hepatic impairment (Child-Pugh Class B) or above
• Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics
• History of seizure disorder
• Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose >125 mg/dL, and/or an HbA1c test >6.5%)
• Individuals with eGFR <60 ml/min/1.72 m\^2 and a urinary albumin/creatinine ratio UACR>300 mg/g
• Anemia, defined by hemoglobin <11.5 g/dL (females) or <13.5 g/dL (males); sickle cell anemia or other blood disorders; and/or wound healing problems
• A clinically significant abnormal ECG and/or QTc interval above normal
• Elevated liver enzymes >75 U/L (ALT or AST)
• Current use of any drugs known to:; Have major drug-drug interactions with mirabegron or alpha-lipoic acid; Be CYP2D6 substrates; Prolong QT interval; Alter glucose metabolism or cause insulin resistance (in last six months); Treat diabetes mellitus; Treat hypertension; Be drugs of abuse
• An individual who meets any of the following criteria will be excluded from participation in this study:
• Elevated resting blood pressure >140/90 mmHg
• Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months
• Addiction to alcohol or substances of abuse within the last 5 years
• Self-reported current alcohol consumption of more than 2 servings of alcohol per day
• Self-reported current use of nicotine and/or tobacco products
• Inability to provide informed consent
• Unwilling or unable to eat metabolic meals, as determined by dietitian consult
• Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator

Egyéb feltételek

• INCLUSION CRITERIA; To be eligible to participate in this study, an individual must meet all of the following criteria:
• Adults 18 to 65 years of age
• BMI greater than or equal to 30 kg/m\^2 and less than or equal to 45 kg/m\^2