Phase 2 N=28 Randomized Quadruple-blind Other

Metabolic Effects of Betaine Supplementation

Obesity · Dysglycemia

Bottom Line

View on ClinicalTrials.gov: NCT01950039 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks. — -5; 3; 7; -4 mg/dl

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Betaine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Joslin Diabetes Center
Primary completion: Dec 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.	-5; 3; 7; -4	—
PRIMARY Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)	340; -413	—
PRIMARY Hepatic Fat, Change From Baseline	-0.01; -0.03	—
PRIMARY Endothelial Function	-0.5; -1.9; -0.9; -0.9	—
PRIMARY Insulin Sensitivity	90.4; 62.8; 110.9; 73.5; 406.8; 332.6	—

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.

Eligibility Criteria

Inclusion Criteria

1) Men and women aged 21-65 years old;
2) Dysglycemia/prediabetes is defined as impaired fasting glucose (≥100 mg/dl), impaired glucose tolerance (2 hour post 75 g oral glucose load 140-200 mg/dl) or HbA1c 5.7-6.5%);
3) overweight to grade 3 obesity (BMI 25 to 45 kg/m2).

Exclusion Criteria

1) cystathionine beta-synthase (CBS deficiency);
2) Presence of liver disease other than NAFLD;
3) Use of medications causing steatosis;
4) Known alcohol consumption ≥ 2 drink per day;
5) Use of medications known to cause insulin resistance;
6) Use of weight loss drugs (or program) within 3 months of screening;
7) Treatment with any experimental drug within the past 6 months;
8) Subjects must be willing to abstain from use of phosphodiesterase type 5 (PDE-5) inhibitors;
9) Pregnancy or lactation, and women of child bearing potential must use adequate contraception;
10) Surgery within 30 days of screening;
11) Heart disease defined as New York Heart Association Class III or IV cardiac status or hospitalization for congestive heart failure, unstable angina, myocardial infarction, cerebrovascular accident, transient ischemic attack or any revascularization within 6 months;
12) Uncontrolled hypertension;
13) eGFR 500 mg/dL;
18) Poor mental function or any other reason to expect patient difficulty in complying with study requirements;
19) Metal clips or implants that preclude magnetic resonance imaging.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01950039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.