Metabolic Effects of Betaine Supplementation

NCT01950039 | Completed Phase 2 Results

• 2 other identifiers: 2013P0012657-13-CE-17
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Dysglycemia

Keywords

Obesity; Glucose Intolerance

Outcome Measures

Primary Outcomes (5)

• Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.

  Glucose levels were analyzed in the fasting state and two hours after glucose load, comparing baseline to 12 weeks.

  baseline and 12 weeks

• Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)

  Glucose tolerance was assessed by oral glucose tolerance, assessed using the change from baseline for fasting and 2 hour glucose, and change in Glucose AUC at 12 weeks from baseline was measured.

  baseline and 12 weeks

• Hepatic Fat, Change From Baseline

  Intrahepatic triglyceride levels were assessed by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (Siemens 3T TIM Skyra, software version VD13; Siemens, Erlangen, Germany).

  baseline and 12 weeks

• Endothelial Function

  Brachial artery reactivity to flow and nitroglycerin stimuli, assessed as percent change from baseline

  baseline and 12 weeks

• Insulin Sensitivity

  Euglycemic hyperinsulinemic clamp at baseline and at end of study (12 weeks) for assessment of: 1. glucose disposal (M) at low (25 mU/m2/min) and high (180 mU/m2/min) insulin infusion rates, reported as raw data 2. measurement of endogenous glucose production at basal and low insulin infusion (25 mU/m2/min), reported as change from measures at baseline of individual study days

  Baseline and 12 weeks

Study Arms (2)

Betaine

ACTIVE COMPARATOR

Drug: Betaine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Betaine DRUG

Betaine or placebo administered orally in divided doses over 12 weeks

Also known as: trimethyl glycine

Betaine

Placebo DRUG

Placebo administered orally in divided doses over 3 months

Placebo

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Men and women aged 21-65 years old;
• \) 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%);
• \) overweight to grade 3 obesity (BMI 25 to 45 kg/m2).

You may not qualify if:

• \) cystathionine beta-synthase (CBS deficiency);
• \) Presence of liver disease other than NAFLD;
• \) Use of medications causing steatosis;
• \) Known alcohol consumption ≥ 2 drink per day;
• \) Use of medications known to cause insulin resistance;
• \) Use of weight loss drugs (or program) within 3 months of screening;
• \) Treatment with any experimental drug within the past 6 months;
• \) Subjects must be willing to abstain from use of phosphodiesterase type 5 (PDE-5) inhibitors;
• \) Pregnancy or lactation, and women of child bearing potential must use adequate contraception;
• \) Surgery within 30 days of screening;
• \) 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;
• \) Uncontrolled hypertension;
• \) eGFR \<60; 14) History of acquired immune deficiency syndrome;
• \) History of malignancy within 5 years;
• \) Hemoglobin \<12 g/dL (males), \<10 g/dL (females);

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• American Diabetes Association: collaborator

Study Sites (1)

Joslin Diabetes Center and Brigham and Womens Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Grizales AM, Patti ME, Lin AP, Beckman JA, Sahni VA, Cloutier E, Fowler KM, Dreyfuss JM, Pan H, Kozuka C, Lee A, Basu R, Pober DM, Gerszten RE, Goldfine AB. Metabolic Effects of Betaine: A Randomized Clinical Trial of Betaine Supplementation in Prediabetes. J Clin Endocrinol Metab. 2018 Aug 1;103(8):3038-3049. doi: 10.1210/jc.2018-00507.

  PMID: 29860335 RESULT

MeSH Terms

Conditions

Obesity; Glucose Intolerance

Interventions

Betaine

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds

Results Point of Contact

• Title: Mary Elizabeth Patti MD
• Organization: Joslin Diabetes Center

mary.elizabeth.patti@joslin.harvard.edu

617 309 2635

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2013
• First Posted: September 25, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: August 1, 2018
• Last Updated: April 20, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-03

Locations

US (1)