Metabolic Effects of Betaine Supplementation

Obesity Clinical Trial

Official title:

Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950039
• Other study ID #: 2013P001265
• Secondary ID: 7-13-CE-17
• Status: Completed
• Phase: Phase 2
• Start date: January 2014
• Est. completion date: August 2018

Study information

• Verified date: March 2021
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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) overweight to grade 3 obesity (BMI 25 to 45 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.

Related Conditions & MeSH terms

• Dysglycemia
• Obesity

Intervention

Drug:
• Betaine
Betaine or placebo administered orally in divided doses over 12 weeks
• Placebo
Placebo administered orally in divided doses over 3 months

Locations

Country	Name	City	State
United States	Joslin Diabetes Center and Brigham and Womens Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	American Diabetes Association

Country where clinical trial is conducted

United States, 

References & 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 Prediabete — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Endothelial Function	Brachial artery reactivity to flow and nitroglycerin stimuli, assessed as percent change from baseline	baseline and 12 weeks
Primary	Insulin Sensitivity	Euglycemic hyperinsulinemic clamp at baseline and at end of study (12 weeks) for assessment of: glucose disposal (M) at low (25 mU/m2/min) and high (180 mU/m2/min) insulin infusion rates, reported as raw data; 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