Clinical trial NCT01950039: Metabolic Effects of Betaine Supplementation
Official title: Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Dysglycemia
Keywords: Obesity
Glucose Intolerance
Lead sponsor: Joslin Diabetes Center
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2013-09-25
Enrollment: 28
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

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 \<60; 14) History of acquired immune deficiency syndrome;
* 15) History of malignancy within 5 years;
* 16) Hemoglobin \<12 g/dL (males), \<10 g/dL (females);
* 17) Triglycerides (TG) \>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.

Primary outcomes:
measure: Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.
timeFrame: baseline and 12 weeks
measure: Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)
timeFrame: baseline and 12 weeks
measure: Hepatic Fat, Change From Baseline
timeFrame: baseline and 12 weeks
measure: Endothelial Function
timeFrame: baseline and 12 weeks
measure: Insulin Sensitivity
timeFrame: Baseline and 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Joslin Diabetes Center and Brigham and Womens Hospital
state: Massachusetts
Study officials:
References:
citation: Grizales AM, Patti ME, Lin AP, Beckman JA, Sahni VA, Cloutier E, Fowler KM, Dreyfuss JM, Pan H, Kozuka C, Lee A, Basu R, Pober DM, Gerszten RE, Goldfine AB. Metabolic Effects of Betaine: A Randomized Clinical Trial of Betaine Supplementation in Prediabetes. J Clin Endocrinol Metab. 2018 Aug 1;103(8):3038-3049. doi: 10.1210/jc.2018-00507.