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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
  Purpose
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.

Condition Intervention Phase
Obesity Dysglycemia Drug: Betaine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation

Resource links provided by NLM:


Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Betaine Drug: Betaine
Betaine or placebo administered orally in divided doses over 3 months.
Other Name: trimethyl glycine
Placebo Comparator: Placebo Drug: Placebo
Placebo administered orally in divided doses over 3 months

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

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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) 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01950039


Locations
United States, Massachusetts
Joslin Diabetes Center and Brigham and Womens Hospital
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
American Diabetes Association
  More Information

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01950039     History of Changes
Other Study ID Numbers: 2013P001265
7-13-CE-17 ( Other Grant/Funding Number: American Diabetes Association 7-13-CE-17 )
First Submitted: September 16, 2013
First Posted: September 25, 2013
Last Update Posted: November 24, 2017
Last Verified: November 2017

Keywords provided by Joslin Diabetes Center:
Obesity
Glucose Intolerance

Additional relevant MeSH terms:
Betaine
Gastrointestinal Agents
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents