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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
  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: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 ] [ 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


Estimated Enrollment: 30
Study Start Date: January 2014
Estimated Primary Completion Date: October 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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950039

Contacts
Contact: Allison B. Goldfine, MD 617-309-2643 allison.goldfine@joslin.harvard.edu

Locations
United States, Massachusetts
Joslin Diabetes Center and Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Allison B. Goldfine, MD    617-309-2643    allison.goldfine@joslin.harvard.edu   
Sponsors and Collaborators
Joslin Diabetes Center
American Diabetes Association
  More Information

No publications provided

Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT01950039     History of Changes
Other Study ID Numbers: 2013P001265, 7-13-CE-17
Study First Received: September 16, 2013
Last Updated: March 24, 2014
Health Authority: United States: Food and Drug Administration
United States: Partners Health Care Institutional Review Board

Keywords provided by Joslin Diabetes Center:
Obesity
Glucose Intolerance

Additional relevant MeSH terms:
Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Betaine
Antimetabolites
Gastrointestinal Agents
Hypolipidemic Agents
Lipid Regulating Agents
Lipotropic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014