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Metabolic Effects of Betaine Supplementation

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01950039
First Posted: September 25, 2013
Last Update Posted: November 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Joslin Diabetes Center
September 16, 2013
September 25, 2013
November 24, 2017
January 2014
December 2017   (Final data collection date for primary outcome measure)
  • Glucose tolerance [ Time Frame: 3 months ]
    Glucose tolerance test
  • Hepatic fat [ Time Frame: 3 months ]
    Magnetic resonance imaging
  • Endothelial Function [ Time Frame: 3 months ]
    Brachial artery reactivity
  • Insulin sensitivity [ Time Frame: 3 months ]
    Euglycemic hyperinsulinemic clamp
Same as current
Complete list of historical versions of study NCT01950039 on ClinicalTrials.gov Archive Site
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
  • 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.
 
Active, not recruiting
30
December 2017
December 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.
Sexes Eligible for Study: All
21 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01950039
2013P001265
7-13-CE-17 ( Other Grant/Funding Number: American Diabetes Association 7-13-CE-17 )
No
Not Provided
Not Provided
Joslin Diabetes Center
Joslin Diabetes Center
American Diabetes Association
Not Provided
Joslin Diabetes Center
November 2017

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