Background:
Obesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \[MG\]) combined with a supplement (alpha-lipoic acid \[ALA\]) may help.
Objective:
To learn how MG and ALA can help the body process food.
Eligibility:
People aged 18 to 65 years with a body mass index between 30 and 45 kg/m2.
Design:
Participants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.
The study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.
During the clinic stays, participants will undergo many tests:
They will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.
They will have imaging scans.
They will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.
Participants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....
Adults 18 to 65 years of age
BMI greater than or equal to 30 kg/m² and less than or equal to 45 kg/m²
Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).
Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).
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%).
Elevated resting blood pressure >140/90 mmHg.
Crossover
Alpha-lipoic acid
DrugALA (2.4g) is in a capsule taken twice per day, once in the morning and once in the evening.
Mirabegron
DrugMirabegron (50mg) is a yellow pill taken once per day in the morning.
Placebo
DrugPlacebo will be visibly similar to ALA capsules. They are off-white, clear vegetable-based capsules containing an inert microcrystalline cellulose powder.
Changes in the Insulin sensitivity index (SI) obtained from FSIGT, in (mU/L)^-1 * min^-1
Change in the Insulin sensitivity index before and after 4 weeks of MG and ALA minus change in the insulin sensitivity index before and after 4 weeks of MG and placebo. This measures a change in insulin sensitivity index following ALA while controlling for changes in insulin sensitivity index due to placebo.Delta SI = (SI after ALA - SI before ALA)- (SI after placebo - SI before placebo)
Maximum observed plasma concentration of ALA (Cmax)
Maximum observed plasma concentration of ALA in ug/mL, measured in serial blood sampling conducted in first 6 hours following MG+ALA dose at study visit
Time to maximum observed plasma concentration of ALA (Tmax)
Tmax of ALA in minutes, measured in serial blood sampling conducted in first 6 hours following MG+ALA dose at study visit
Area under the concentration-time curve for ALA
AUC calculated by measuring ALA concentrations in serial blood samples taken in first 6 hours following MG+ALA dose at study visit
Changes in adipose tissue local inflammation in adipose tissue biopsy samples
Calculated as number of macrophages per high-power fieldChange in inflammation = (macrophages after ALA - macrophages before ALA) - (macrophages after placebo - macrophages before placebo)
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