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

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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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow for 3 periods

Period 1:   First Sequence
    MCT Intervention First, Then Placebo   Placebo Intervention First, Then MCT Intervention
STARTED   6   6 
COMPLETED   6   6 
NOT COMPLETED   0   0 

Period 2:   Wash Out Period
    MCT Intervention First, Then Placebo   Placebo Intervention First, Then MCT Intervention
STARTED   6   6 
COMPLETED   5   5 
NOT COMPLETED   1   1 
Lost to Follow-up                1                1 

Period 3:   Second Sequence
    MCT Intervention First, Then Placebo   Placebo Intervention First, Then MCT Intervention
STARTED   5   5 
COMPLETED   5   5 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The baseline number of subjects reflects the number of subjects with baseline data

Reporting Groups
  Description
Overall Number of Subjects 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.

Baseline Measures
   Overall Number of Subjects 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.8  (8.9) 
Gender 
[Units: Participants]
 
Female   6 
Male   5 


  Outcome Measures

1.  Primary:   Immediate Verbal Memory   [ Time Frame: 90 minutes ]

2.  Primary:   Delayed Verbal Memory   [ Time Frame: 90 minutes ]

3.  Primary:   Verbal Memory Recognition   [ Time Frame: 90 minutes ]

4.  Primary:   Digit Span Backward   [ Time Frame: 90 minutes ]

5.  Primary:   Letter/Number Sequencing   [ Time Frame: 90 minutes ]

6.  Primary:   Digit Symbol Coding   [ Time Frame: 90 minutes ]

7.  Primary:   Map Search (2min)   [ Time Frame: 90 minutes ]

8.  Primary:   Map Search (1min)   [ Time Frame: 90 minutes ]

9.  Primary:   Telephone Search   [ Time Frame: 90 minutes ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No technical limitations were seen.


  More Information

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
e-mail: robert.sherwin@yale.edu



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