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Metabolic Effects of Betaine Supplementation

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ClinicalTrials.gov Identifier: NCT01950039
Recruitment Status : Active, not recruiting
First Posted : September 25, 2013
Last Update Posted : February 16, 2018
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Joslin Diabetes Center

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.

Condition or disease Intervention/treatment Phase
Obesity Dysglycemia Drug: Betaine Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : January 2014
Actual Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Glucose tolerance [ Time Frame: 3 months ]
    Glucose tolerance test

  2. Hepatic fat [ Time Frame: 3 months ]
    Magnetic resonance imaging

  3. Endothelial Function [ Time Frame: 3 months ]
    Brachial artery reactivity

  4. Insulin sensitivity [ Time Frame: 3 months ]
    Euglycemic hyperinsulinemic clamp



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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.

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

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 Posted: September 25, 2013    Key Record Dates
Last Update Posted: February 16, 2018
Last Verified: February 2018

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