Diabetes Mellitus, Type 1NCT00592072
Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
A study testing Medium chain fatty acid (Octanoic and Decanoic acid) in people with Diabetes Mellitus, Type 1, run by Yale University at 1 site in United States.
Trial summary
At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Medium chain fatty acid (Octanoic and Decanoic acid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jul 2008
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 1 Diabetes Mellitus for greater than 5 years (C-peptide negative)
- Age 18-55 years
- Subject is on intensive insulin therapy resulting in a Hemoglobin A1c of less than 7.5%
- History of frequent hypoglycemic events as defined as having at least one blood glucose of less than 60 mg/dl in the last four weeks
Who cannot join
- History of hypoglycemia induced seizures
- Pregnancy
- Significant baseline anemia (hemoglobin < 11.0g/dl or hematocrit < 33%)
- A history of liver cirrhosis or porto-caval shunt surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1 Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)
Read the detailed description
Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes Mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be administered. Each subject will experience both conditions. The order in which the MCFA is given will be randomized.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Medium chain fatty acid (Octanoic and Decanoic acid), Splenda (Placebo Control)
- Keywords
- Diabetes Mellitus, Type 1, Medium Chain Fatty Acid, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium chain fatty acid (Octanoic and Decanoic acid)Dietary supplement
Also called Medium Chain Triglycerides, Octanoic and Decanoic acid, Fractionated coconut oil
Octanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations.
Splenda (Placebo Control)Other
Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor.
| Study group | Role | What they receive |
|---|---|---|
| Medium chain fatty acid (Octanoic and Decanoic acid) | Experimental | Not described Receives: Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid) |
| Splenda (Placebo Control) | Placebo comparator | Not described Receives: Other: Splenda (Placebo Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Verbal Memory
Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.
Measured: 90 minutes
Delayed Verbal Memory
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Measured: 90 minutes
Verbal Memory Recognition
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Measured: 90 minutes
Digit Span Backward
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
Measured: 90 minutes
Letter/Number Sequencing
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Measured: 90 minutes
Digit Symbol Coding
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Measured: 90 minutes
Map Search (2min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Measured: 90 minutes
Map Search (1min)
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Measured: 90 minutes
Telephone Search
This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startJul 2005
- Primary completionJul 2008
- Study completionJul 2008
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.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation
- Responsible party
- Sponsor
- Investigators
- Robert Sherwin, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592072
- Sponsor's protocol ID
- DK66108b_0505000079
- Other IDs
- R37DK020495, DK20495
- Status last verified
- Jan 2015
- First submitted
- 26 Dec 2007
- Last updated
- 22 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT00592072
- Acronym / sponsor ID
- DK66108b_0505000079
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Medium Chain Fatty Acid, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Juvenile Diabetes Research Foundation
- Study start
- Jul 2005
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Posted 5 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
At present, there are no therapeutic agents that can minimize severe hypoglycemia (low blood sugar) and its effects on long-term brain function. The aim of this study is to determine whether the human brain is able to use medium chain fatty acids (MCFA) and/or their metabolites as an alternative fuel source during acute hypoglycemia in patients with Type 1 Diabetes Mellitus (T1DM). The hypothesis is that medium chain fatty acids will provide a rapidly absorbed, non-carbohydrate fuel that will improve cognitive performance during episodes of hypoglycemia (low blood sugar.)
Detailed description
Twelve subjects between the ages of 18 years and 55 years who have had Type 1 Diabetes Mellitus for more than five years and have had tight control of their diabetes as determined by screening blood work will be invited to participate. Each study subject will undergo two hypoglycemic clamp studies (a procedure where the blood sugar is closely regulated with intravenous insulin and glucose.) In these hypoglycemic clamp studies, cognitive testing will be performed during 90 minutes of normal blood glucose followed by 90 minutes of hypoglycemia. During the hypoglycemic period, either the MCFA or a placebo will be administered. Each subject will experience both conditions. The order in which the MCFA is given will be randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medium chain fatty acid (Octanoic and Decanoic acid) | Experimental | Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid) |
| Splenda (Placebo Control) | Placebo comparator | Other: Splenda (Placebo Control) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Type 1 Diabetes Mellitus for greater than 5 years (C-peptide negative)
- Age 18-55 years
- Subject is on intensive insulin therapy resulting in a Hemoglobin A1c of less than 7.5%
- History of frequent hypoglycemic events as defined as having at least one blood glucose of less than 60 mg/dl in the last four weeks
Key exclusion criteria (4 listed)
- History of hypoglycemia induced seizures
- Pregnancy
- Significant baseline anemia (hemoglobin < 11.0g/dl or hematocrit < 33%)
- A history of liver cirrhosis or porto-caval shunt surgery
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 fatty acid (Octanoic and Decanoic acid)Also: Medium Chain Triglycerides, Octanoic and Decanoic acid, Fractionated coconut oilOctanoic acid(67%) and Decanoic acid (27%); MCFA 50g total at 25 minute intervals with front loading of 20g then 10g for three administrations. | Dietary supplement | Medium chain fatty acid (Octanoic and Decanoic acid) |
| Splenda (Placebo Control)Placebo drink will consist of dietary sweetener Splenda mixed in water at a concentration of 1g/100mL. An unsweetened cherry flavor Koolaid mix will be added at a concentration of 0.3g/100mL of the Splenda drink to enhance flavor. | Other | Splenda (Placebo Control) |
Primary outcome
Immediate Verbal Memory
Time frame: 90 minutes
Results of cognitive function in diabetic patients using tests such as digit symbol substitution (a test of memory), tests of everyday attention, telephone book searching and map searching during either administration of medium chain triglyceride oil or a control solution. The goal was to determine whether the human brain is able to use medium-chain fatty acids (MCFA) and /or their metabolites as an alternative fuel source and thus improve brain function during acute hypoglycemia in patients with type 1 diabetes. The lowest score is 0 and the highest score is 25. A higher score is an improvement.
Delayed Verbal Memory
Time frame: 90 minutes
The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Verbal Memory Recognition
Time frame: 90 minutes
The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Digit Span Backward
Time frame: 90 minutes
The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
Letter/Number Sequencing
Time frame: 90 minutes
The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Digit Symbol Coding
Time frame: 90 minutes
The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Map Search (2min)
Time frame: 90 minutes
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Map Search (1min)
Time frame: 90 minutes
The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Telephone Search
Time frame: 90 minutes
This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Sherwin, M.D. principal investigator
Yale University
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 fatty acid (Octanoic and Decanoic acid) in people with Diabetes Mellitus, Type 1, run by Yale University 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 4 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 22 Jan 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2015). 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?
Immediate Verbal Memory (time frame: 90 minutes). The study lists 9 primary outcomes in all. 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 22 Jan 2015.