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Completed

NCT Number: NCT01950039

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.

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Key information

Conditions

Obesity Body Weight Dysglycemia Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Joslin Diabetes Center and Brigham and Womens Hospital

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Betaine

Drug

Betaine or placebo administered orally in divided doses over 12 weeks

Other names: trimethyl glycine

Placebo

Drug

Placebo administered orally in divided doses over 3 months

Primary outcomes

  1. Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.

    Time frame: baseline and 12 weeks

    Glucose levels were analyzed in the fasting state and two hours after glucose load, comparing baseline to 12 weeks.

  2. Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)

    Time frame: baseline and 12 weeks

    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.

  3. Hepatic Fat, Change From Baseline

    Time frame: baseline and 12 weeks

    Intrahepatic triglyceride levels were assessed by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (Siemens 3T TIM Skyra, software version VD13; Siemens, Erlangen, Germany).

  4. Endothelial Function

    Time frame: baseline and 12 weeks

    Brachial artery reactivity to flow and nitroglycerin stimuli, assessed as percent change from baseline

  5. Insulin Sensitivity

    Time frame: Baseline and 12 weeks

    Euglycemic hyperinsulinemic clamp at baseline and at end of study (12 weeks) for assessment of:

    • glucose disposal (M) at low (25 mU/m2/min) and high (180 mU/m2/min) insulin infusion rates, reported as raw data
    • 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

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Sep 25, 2013
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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