Trial Outcomes & Findings for Effect of Medium Chain Fatty Acids on Cognitive Function During Acute Hypoglycemia in Patients With Type 1 Diabetes (NCT NCT00592072)

NCT ID: NCT00592072

Last Updated: 2015-01-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 90 minutes
• Results posted on: 2015-01-22

Participant Flow

Participant milestones

Measure	MCT Intervention First, Then Placebo 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	Placebo Intervention First, Then MCT Intervention 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
First Sequence STARTED	6	6
First Sequence COMPLETED	6	6
First Sequence NOT COMPLETED	0	0
Wash Out Period STARTED	6	6
Wash Out Period COMPLETED	5	5
Wash Out Period NOT COMPLETED	1	1
Second Sequence STARTED	5	5
Second Sequence COMPLETED	5	5
Second Sequence NOT COMPLETED	0	0

Reasons for withdrawal

Measure	MCT Intervention First, Then Placebo 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	Placebo Intervention First, Then MCT Intervention 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
Wash Out Period Lost to Follow-up	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Overall Number of Subjects n=11 Participants 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.
Age, Continuous	34.8 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

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.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Immediate Verbal Memory Euglycemia	15.85 units on a scale Standard Error 0.66	17.36 units on a scale Standard Error 13.28
Immediate Verbal Memory Hypoglycemia	14.97 units on a scale Standard Error 1.13	13.28 units on a scale Standard Error 1.04

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

The highest score is 25 and the lowest score is 0. The higher scored indicate an improvement.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Delayed Verbal Memory Euglycemia	14.82 units on a scale Standard Error 1.25	15.33 units on a scale Standard Error 1.40
Delayed Verbal Memory Hypoglycemia	14.80 units on a scale Standard Error 1.31	11.58 units on a scale Standard Error 0.71

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

The highest score is 15. The lowest score is 0. Higher scores indicate an improvement.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Verbal Memory Recognition Euglycemia	13.19 units on a scale Standard Error 0.53	14.27 units on a scale Standard Error 0.23
Verbal Memory Recognition Hypoglycemia	13.29 units on a scale Standard Error 0.50	12.14 units on a scale Standard Error 0.19

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

The highest score is 35. The lowest score is 0. The higher the score indicates an improvement.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Digit Span Backward Euglycemia	0.60 units on a scale Standard Error 0.05	0.64 units on a scale Standard Error 0.05
Digit Span Backward Hypoglycemia	0.58 units on a scale Standard Error 0.05	0.54 units on a scale Standard Error 0.05

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

The highest score is 21. The lowest score is 0. Higher scores indicate an improvement.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Letter/Number Sequencing Euglycemia	12.04 units on a scale Standard Error 0.81	11.07 units on a scale Standard Error 0.85
Letter/Number Sequencing Hypoglycemia	10.97 units on a scale Standard Error 0.76	9.92 units on a scale Standard Error 0.71

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

The highest score is 133. The lowest score is 0. Higher scores indicate an improvement.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Digit Symbol Coding Euglycemia	72.50 units on a scale Standard Error 5.27	74.04 units on a scale Standard Error 4.59
Digit Symbol Coding Hypoglycemia	74.99 units on a scale Standard Error 4.56	68.56 units on a scale Standard Error 3.54

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Map Search (2min) Hypoglycemia	75.11 units on a scale Standard Error 1.51	74.67 units on a scale Standard Error 1.51
Map Search (2min) Euglycemia	73.30 units on a scale Standard Error 1.70	75.04 units on a scale Standard Error 1.92

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

The highest score is 80. The lowest score is 0. Higher scores indicate an improvement.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Map Search (1min) Euglycemia	53.11 units on a scale Standard Error 4.16	50.35 units on a scale Standard Error 3.27
Map Search (1min) Hypoglycemia	48.42 units on a scale Standard Error 3.19	42.94 units on a scale Standard Error 2.31

PRIMARY outcome

Timeframe: 90 minutes

Population: 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.

This is a ratio of how many symbols are found during a certain period of time. The highest ratio is the best result.

Outcome measures

Measure	Type 1 Diabetes With MCT Oil n=10 Participants Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.	Type 1 Diabetes Without MCT Oil n=10 Participants Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
Telephone Search Euglycemia	2.86 symbols/ 90 min Standard Error 0.17	3.14 symbols/ 90 min Standard Error 0.26
Telephone Search Hypoglycemia	3.06 symbols/ 90 min Standard Error 0.20	3.46 symbols/ 90 min Standard Error 0.34

Adverse Events

MCT Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Placebo Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MCT Intervention n=12 participants at risk	Placebo Intervention n=12 participants at risk
Gastrointestinal disorders Gastrointestinal Symptoms	25.0% 3/12	0.00% 0/12

Additional Information

Dr Robert Sherwin

Yale School of Medicine

Phone: 203-785-6222

Email: robert.sherwin@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place