Metabolic Effects of Betaine Supplementation

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Joslin Diabetes Center
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01950039
First received: September 16, 2013
Last updated: March 24, 2014
Last verified: March 2014

September 16, 2013
March 24, 2014
January 2014
October 2017   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01950039 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Metabolic Effects of Betaine Supplementation
Bedside to Bench and Back: Cardiometabolic 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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Obesity
  • Dysglycemia
  • Drug: Betaine
    Betaine or placebo administered orally in divided doses over 3 months.
    Other Name: trimethyl glycine
  • Drug: Placebo
    Placebo administered orally in divided doses over 3 months
  • Active Comparator: Betaine
    Intervention: Drug: Betaine
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
October 2017   (final data collection date for primary outcome measure)

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) Grade 1 obesity (BMI 27 to 36 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.
Both
21 Years to 65 Years
No
Contact: Allison B. Goldfine, MD 617-309-2643 allison.goldfine@joslin.harvard.edu
United States
 
NCT01950039
2013P001265, 7-13-CE-17
No
Joslin Diabetes Center
Joslin Diabetes Center
American Diabetes Association
Not Provided
Joslin Diabetes Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP