Insulin ResistanceNCT02783703
Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
A study testing Medium chain triglycerides (MCT) in people with Insulin Resistance, run by Boston Medical Center at 1 site in United States.
Trial summary
The study team will investigate the racial differences in the metabolic and clinical responses to Medium chain triglycerides (MCT) between African American and Caucasian American subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Medium chain triglycerides (MCT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2017to 20 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English-speaking
- Males and female ambulatory subjects
- Self-identify as Caucasian/White or Black/African American
- Body Mass Index <=45
Who cannot join
- Diagnosis of type 2 diabetes or hemoglobin A1c >6.5
- Use of insulin, oral hypoglycemic, agents, or insulin-sensitizing agents
- Daily use of oral steroids
- Unstable weight within 3 months prior to baseline (e.g., weight gain or loss of >3%)
- Use of any weight loss medications or sex hormone therapy
- Daily use of psychotropic medications (for schizophrenia, bipolar disorder, obsessive compulsive disorder, posttraumatic stress disorder, psychotic disorder, mania)
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- Chronic kidney disease, on dialysis or history of renal transplant
- Poorly controlled cardiovascular disease or congestive heart failure
- Severe peripheral vascular disease or severe liver disease
- Cancer
- A condition requiring use of oxygen such as severe chronic obstructive pulmonary disease
- Women who are pregnant, lactating, or actively trying to become pregnant
- Any cognitive or other disorders that may interfere with participation or ability to follow restrictions
- Abnormal TSH levels (<0.01 or >1.5x the upper limit)
- Weight >450 lb (205 kg) or height > 6'6"
- Severe claustrophobia
- Has had or is preparing for bariatric surgery (pre- or post-bariatric)
- Medically required use of anticoagulant therapies
- Current use of MCT oil
- Anemia (hemoglobin and/or hematocrit outside sex-specific normal ranges)
Trial locations and contacts
1 site in 1 country.
About this study
The study team will investigate the racial differences in the metabolic and clinical responses to Medium chain triglycerides (MCT) between African American and Caucasian American subjects.
Read the detailed description
It is generally accepted that type 2 diabetes (T2D) arises from the progression of insulin resistance (IR), with hyperinsulinemia (HI) as a compensatory response. The possibility that HI can precede and contribute to insulin resistance (IR) and metabolic syndrome (MS) has been suggested but not tested in humans. While IR and HI are closely associated, demonstrating a primary role for HI in T2D is key to the development of new treatment strategies for this disease. One group in which HI could play a bigger role in T2D is African Americans (AA) who are known to be more hyperinsulinemic than Caucasian Americans (CA). Racial disparities in T2D treatment outcomes adversely affect AA. Our main hypothesis is that suppression of HI will contribute to the prevention and treatment of T2D, especially among AA. Our goal in this pilot study is to show that consumption of medium chain triglycerides (MCT) in the diet will decrease basal insulin secretion and HI, and will lead to improvement in the insulin sensitivity index (Si). 24 subjects (12 AA, 12 CA) will participate in a clinical trial in which they will receive MCT for 6 weeks. Insulin secretion dynamics and insulin sensitivity will be assessed by use of the frequently sampled intravenous glucose tolerance test (FSIVGTT) and Bergman's minimal model analysis.
- Conditions
- Insulin Resistance
- Being tested
- Medium chain triglycerides (MCT)
- Keywords
- Hyperinsulinemia
- Medical subject headings
- Insulin Resistance, Hyperinsulinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium chain triglycerides (MCT)Dietary supplement
Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth
| Study group | Role | What they receive |
|---|---|---|
| MCT | Experimental | Medium chain triglyceride (MCT) oil ingested daily for 6 weeks Receives: Dietary Supplement: Medium chain triglycerides (MCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test
Measured: Baseline to 6 weeks
Secondary outcomes (4)
Change from baseline to 6 weeks in resting energy expenditure (kilocalories)
Measured: Baseline to 6 weeks
Change from baseline to 6 weeks in body composition (% fat, muscle and bone)
Measured: Baseline to 6 weeks
Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed)
Measured: Baseline to 6 weeks
Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start28 Apr 2017
- Primary completion20 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University
- Responsible party
- Principal investigator, Caroline Apovian, Boston Medical Center
- Investigators
- Caroline M Apovian, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783703
- Sponsor's protocol ID
- H-35267
- Status last verified
- May 2019
- First submitted
- 23 May 2016
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Medium Chain Triglycerides in a Mixed Racial Population of Patients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02783703
- Acronym / sponsor ID
- H-35267
- Conditions
- Insulin Resistance
- Keywords
- Hyperinsulinemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- Boston University
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study team will investigate the racial differences in the metabolic and clinical responses to Medium chain triglycerides (MCT) between African American and Caucasian American subjects.
Detailed description
It is generally accepted that type 2 diabetes (T2D) arises from the progression of insulin resistance (IR), with hyperinsulinemia (HI) as a compensatory response. The possibility that HI can precede and contribute to insulin resistance (IR) and metabolic syndrome (MS) has been suggested but not tested in humans. While IR and HI are closely associated, demonstrating a primary role for HI in T2D is key to the development of new treatment strategies for this disease. One group in which HI could play a bigger role in T2D is African Americans (AA) who are known to be more hyperinsulinemic than Caucasian Americans (CA). Racial disparities in T2D treatment outcomes adversely affect AA. Our main hypothesis is that suppression of HI will contribute to the prevention and treatment of T2D, especially among AA. Our goal in this pilot study is to show that consumption of medium chain triglycerides (MCT) in the diet will decrease basal insulin secretion and HI, and will lead to improvement in the insulin sensitivity index (Si). 24 subjects (12 AA, 12 CA) will participate in a clinical trial in which they will receive MCT for 6 weeks. Insulin secretion dynamics and insulin sensitivity will be assessed by use of the frequently sampled intravenous glucose tolerance test (FSIVGTT) and Bergman's minimal model analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCT | Experimental | Dietary Supplement: Medium chain triglycerides (MCT)Medium chain triglyceride (MCT) oil ingested daily for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English-speaking
- Males and female ambulatory subjects
- Self-identify as Caucasian/White or Black/African American
- Body Mass Index <=45
Key exclusion criteria (20 listed)
- Diagnosis of type 2 diabetes or hemoglobin A1c >6.5
- Use of insulin, oral hypoglycemic, agents, or insulin-sensitizing agents
- Daily use of oral steroids
- Unstable weight within 3 months prior to baseline (e.g., weight gain or loss of >3%)
- Use of any weight loss medications or sex hormone therapy
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 |
|---|---|---|
| Medium chain triglycerides (MCT)Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth | Dietary supplement | MCT |
Primary outcome
Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test
Time frame: Baseline to 6 weeks
4 secondary outcomes
Change from baseline to 6 weeks in resting energy expenditure (kilocalories)
Time frame: Baseline to 6 weeks
Change from baseline to 6 weeks in body composition (% fat, muscle and bone)
Time frame: Baseline to 6 weeks
Change baseline to 6 weeks in physical activity (minutes of moderate or vigorous activity performed)
Time frame: Baseline to 6 weeks
Assessment of the following from Baseline to end of intervention: Adverse Events (AEs), Vital Signs, Anthropometrics
Time frame: Baseline to 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No. Patient data is protected by HIPAA. Results will be published in a peer-reviewed journal.
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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.
Caroline M Apovian, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medium chain triglycerides (MCT) in people with Insulin Resistance, run by Boston Medical 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 4 inclusion and 20 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 30 May 2019. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in insulin sensitivity to 6 weeks as measured by intravenous glucose tolerance test (time frame: Baseline to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 May 2019.