ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00592072
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : January 5, 2015
Last Update Posted : January 22, 2015
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Dietary Supplement: Medium chain fatty acid (Octanoic and Decanoic acid)
Other: Splenda (Placebo Control)
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title MCT Intervention First, Then Placebo Placebo Intervention First, Then MCT Intervention
Hide Arm/Group Description A total of 40 grams of medium-chain triglycerides (derived from coconut oil containing 67% octanoate, 27% decanaote, and 6% other fatty acids) is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice A total of 40 grams of cherry-flavored water sweetened with sucralose is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
Period Title: First Sequence
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Wash Out Period
Started 6 6
Completed 5 5
Not Completed 1 1
Reason Not Completed
Lost to Follow-up             1             1
Period Title: Second Sequence
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title Overall Number of Subjects
Hide Arm/Group Description 12 subjects started the study and 10 completed the study, however 11 subjects are reported in the baseline characteristics because one subjects withdrew before baseline data was collected.
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
The baseline number of subjects reflects the number of subjects with baseline data
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
34.8  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
1.Primary Outcome
Title Immediate Verbal Memory
Hide Description 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.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 15.85  (0.66) 17.36  (13.28)
Hypoglycemia 14.97  (1.13) 13.28  (1.04)
2.Primary Outcome
Title Delayed Verbal Memory
Hide Description The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 14.82  (1.25) 15.33  (1.40)
Hypoglycemia 14.80  (1.31) 11.58  (0.71)
3.Primary Outcome
Title Verbal Memory Recognition
Hide Description The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 13.19  (0.53) 14.27  (0.23)
Hypoglycemia 13.29  (0.50) 12.14  (0.19)
4.Primary Outcome
Title Digit Span Backward
Hide Description The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 0.60  (0.05) 0.64  (0.05)
Hypoglycemia 0.58  (0.05) 0.54  (0.05)
5.Primary Outcome
Title Letter/Number Sequencing
Hide Description The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 12.04  (0.81) 11.07  (0.85)
Hypoglycemia 10.97  (0.76) 9.92  (0.71)
6.Primary Outcome
Title Digit Symbol Coding
Hide Description The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 72.50  (5.27) 74.04  (4.59)
Hypoglycemia 74.99  (4.56) 68.56  (3.54)
7.Primary Outcome
Title Map Search (2min)
Hide Description The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 73.30  (1.70) 75.04  (1.92)
Hypoglycemia 75.11  (1.51) 74.67  (1.51)
8.Primary Outcome
Title Map Search (1min)
Hide Description The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Euglycemia 53.11  (4.16) 50.35  (3.27)
Hypoglycemia 48.42  (3.19) 42.94  (2.31)
9.Primary Outcome
Title Telephone Search
Hide Description This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.
Time Frame 90 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
With the validation span test, a decrease in cognitive performance from euglycemia to hypoglycemia (22+/-2.3 vs 13.4+/-2.5) or a difference of 8.6 has been reported. Using this, a sample size of 12 will provide 80% power to detect a 23% (i.e. 2 unit) attenuation of the effect of hypoglycemia on cognitive performance.
Arm/Group Title Type 1 Diabetes With MCT Oil Type 1 Diabetes Without MCT Oil
Hide Arm/Group Description:
Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Overall Number of Participants Analyzed 10 10
Least Squares Mean (Standard Error)
Unit of Measure: symbols/ 90 min
Euglycemia 2.86  (0.17) 3.14  (0.26)
Hypoglycemia 3.06  (0.20) 3.46  (0.34)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title MCT Intervention Placebo Intervention
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
MCT Intervention Placebo Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
MCT Intervention Placebo Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
MCT Intervention Placebo Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   3/12 (25.00%)   0/12 (0.00%) 
Gastrointestinal disorders     
Gastrointestinal Symptoms   3/12 (25.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr Robert Sherwin
Organization: Yale School of Medicine
Phone: 203-785-6222
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00592072     History of Changes
Other Study ID Numbers: DK66108b_0505000079
R37DK020495 ( U.S. NIH Grant/Contract )
DK20495
First Submitted: December 26, 2007
First Posted: January 11, 2008
Results First Submitted: February 4, 2013
Results First Posted: January 5, 2015
Last Update Posted: January 22, 2015