ObesityPhase 2NCT01950039

Metabolic Effects of Betaine Supplementation

A Phase 2 study testing Betaine in people with Obesity and Dysglycemia, run by Joslin Diabetes Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 70 years
Conditions the study is for: Obesity, Dysglycemia
What is being tested?: Betaine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Aug 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

Show all 18Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Joslin Diabetes Center and Brigham and Womens Hospital
Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation

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.

Read the 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.

Conditions: Obesity, Dysglycemia
Being tested: Betaine, Placebo
Keywords: Obesity, Glucose Intolerance
Medical subject headings: Obesity, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BetaineDrug
Also called trimethyl glycine
Betaine or placebo administered orally in divided doses over 12 weeks
PlaceboDrug
Placebo administered orally in divided doses over 3 months

Study groups in NCT01950039
Study group	Role	What they receive
Betaine	Active comparator	Not described Receives: Drug: Betaine
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
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).
Measured: baseline and 12 weeks
Endothelial Function
Brachial artery reactivity to flow and nitroglycerin stimuli, assessed as percent change from baseline
Measured: 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
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2014Aug 2018

First posted25 Sep 2013 (estimated)
Study startJan 2014
Primary completionDec 2017
Study completionAug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01950039
Sponsor's protocol ID: 2013P001265
Other IDs: 7-13-CE-17
Status last verified: Mar 2021
First submitted: 16 Sep 2013
Last updated: 20 Apr 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 29860335

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bedside to Bench and Back: Cardiometabolic Effects of Betaine Supplementation
ClinicalTrials.gov ID: NCT01950039
Acronym / sponsor ID: 2013P001265
Conditions: Obesity, Dysglycemia
Keywords: Obesity, Glucose Intolerance
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Joslin Diabetes CenterUniversity, hospital or other
Collaborators: American Diabetes Association
Study start: Jan 2014
Primary completion: Dec 2017 (actual)
Study completion: Aug 2018 (actual)
First posted: 25 Sep 2013 (estimated)
Results: Posted 20 Apr 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Betaine	Active comparator	Drug: Betaine
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (18 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BetaineAlso: trimethyl glycineBetaine or placebo administered orally in divided doses over 12 weeks	Drug	Betaine
PlaceboPlacebo administered orally in divided doses over 3 months	Drug	Placebo

Primary outcome

Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.
Time frame: baseline and 12 weeks
Glucose levels were analyzed in the fasting state and two hours after glucose load, comparing baseline to 12 weeks.
Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)
Time frame: baseline and 12 weeks
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.
Hepatic Fat, Change From Baseline
Time frame: baseline and 12 weeks
Intrahepatic triglyceride levels were assessed by magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (Siemens 3T TIM Skyra, software version VD13; Siemens, Erlangen, Germany).
Endothelial Function
Time frame: baseline and 12 weeks
Brachial artery reactivity to flow and nitroglycerin stimuli, assessed as percent change from baseline
Insulin Sensitivity
Time frame: Baseline and 12 weeks
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

Results and safety

Results posted to the registry on 20 Apr 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Betaine	15	14
Placebo	13	13

Primary outcome: Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks.

Time frame: baseline and 12 weeks. Mean (95% Confidence Interval). Unit: mg/dl

Measure	Betaine n = 14	Placebo n = 13
fasting glucose	-5 (-12 to 1)	3 (-4 to 9)
2-hour glucose	7 (-10 to 25)	-4 (-22 to 13)

Primary outcome: Change in Glucose AUC at 12 Weeks From Baseline (Glucose Tolerance)

Time frame: baseline and 12 weeks. Mean (95% Confidence Interval). Unit: mg*min/dL

Measure	Betaine n = 14	Placebo n = 13
Value	340 (-993 to 1672)	-413 (-1749 to 923)

Primary outcome: Hepatic Fat, Change From Baseline

Time frame: baseline and 12 weeks. Mean (Standard Error). Unit: percent change in hepatic triglyceride

Measure	Betaine n = 13	Placebo n = 12
Value	-0.01 (0.02)	-0.03 (0.02)

Primary outcome: Endothelial Function

Time frame: baseline and 12 weeks. Mean (95% Confidence Interval). Unit: percent change from baseline

Measure	Betaine n = 14	Placebo n = 13
Percent change in flow-mediated dilation	-0.5 (-3.3 to 2.3)	-1.9 (-4.7 to 1.0)
Percent change in nitroglycerine-mediated dilation	-0.9 (-4.0 to 2.1)	-0.9 (-4.1 to 2.4)

Population analysed: One participant in the placebo group was not able to complete nitroglycerine-mediated dilation assessment.

Adverse events

Time frame: Adverse event data were collected for 14 weeks (during study drug administration and for 2 weeks after last study drug).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Betaine	0 of 14 (0%)	4 of 14 (28.6%)	0 of 14
Placebo	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 29860335Grizales 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Betaine in people with Obesity and Dysglycemia, run by Joslin Diabetes Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting and 2 Hour Glucose Levels, Comparing Baseline and 12 Weeks. (time frame: baseline and 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01950039, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.