Metabolic Effects of Betaine Supplementation
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation|
- Glucose tolerance [ Time Frame: 3 months ] [ Designated as safety issue: No ]Glucose tolerance test
- Hepatic fat [ Time Frame: 3 months ] [ Designated as safety issue: No ]Magnetic resonance imaging
- Endothelial Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]Brachial artery reactivity
- Insulin sensitivity [ Time Frame: 3 months ] [ Designated as safety issue: No ]Euglycemic hyperinsulinemic clamp
|Study Start Date:||January 2014|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
|Active Comparator: Betaine||
Betaine or placebo administered orally in divided doses over 3 months.
Other Name: trimethyl glycine
|Placebo Comparator: Placebo||
Placebo administered orally in divided doses over 3 months
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.
|Contact: Allison B. Goldfine, MDemail@example.com|
|United States, Massachusetts|
|Joslin Diabetes Center and Brigham and Womens Hospital||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Allison B. Goldfine, MD 617-309-2643 firstname.lastname@example.org|