Betaine is important in cellular metabolic pathways. Few epidemiologic studies link betaine levels to diabetes and cardiovascular disease. Small human studies suggest benefit for non-alcoholic liver disease. In this study we will determine if administration of betaine improves metabolic measures, liver fat and/or endothelial function in humans with glucose intolerance who are overweight.
This study is a single site, prospective, randomized (1:1), double masked, placebo controlled trial to assess metabolic effects of betaine compared to placebo on glycemia and insulin sensitivity, liver fat and endothelial function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
28
Joslin Diabetes Center and Brigham and Womens Hospital
Boston, Massachusetts, United States
Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.
Glucose levels were analyzed in the fasting state and two hours after glucose load, comparing baseline to 12 weeks.
Time frame: baseline and 12 weeks
Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)
Glucose tolerance was assessed by oral glucose tolerance, assessed using the change from baseline for fasting and 2 hour glucose, and change in Glucose AUC at 12 weeks from baseline was measured.
Time frame: baseline and 12 weeks
Hepatic Fat, Change From Baseline
Intrahepatic triglyceride levels were assessed by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (Siemens 3T TIM Skyra, software version VD13; Siemens, Erlangen, Germany).
Time frame: baseline and 12 weeks
Endothelial Function
Brachial artery reactivity to flow and nitroglycerin stimuli, assessed as percent change from baseline
Time frame: baseline and 12 weeks
Insulin Sensitivity
Euglycemic hyperinsulinemic clamp at baseline and at end of study (12 weeks) for assessment of: 1. glucose disposal (M) at low (25 mU/m2/min) and high (180 mU/m2/min) insulin infusion rates, reported as raw data 2. measurement of endogenous glucose production at basal and low insulin infusion (25 mU/m2/min), reported as change from measures at baseline of individual study days
Time frame: Baseline and 12 weeks
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