CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Betaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01950039
NCT01950039Phase 2Completed
CompareCT.gov

Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation

Joslin Diabetes Center·interventional·Posted Sep 25, 2013·Updated Apr 20, 2021

In Brief

A Phase 2 clinical trial evaluating Betaine and Placebo for Obesity and Dysglycemia. Completed, enrolled 28 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Dysglycemia
CountriesUnited States
CollaboratorsAmerican Diabetes Association

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 25, 2013
Enrollment StartJan 1, 2014
Primary CompletionDec 1, 2017
Study CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 12.8 years ago

Interventions

Betainedrug

Betaine or placebo administered orally in divided doses over 12 weeks

Placebodrug

Placebo administered orally in divided doses over 3 months